,,ii #aafth ,,congress #b;d ,session ,s4 #cdjd ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,march #e1 #bjbj,mr4 ,burr 7for himself and ,mr4 ,bennet7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act to provide for the regulation of in vitro clinical tests1 and for other purposes4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,verifying ,accurate ,leading-edge ,,ivct ,development ,act of #bjbj or the ,,valid ,act of #bjbj4 7b7 ,table of contents ,the table of contents of this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4 ,sec4 #b4 ,definitions4 ,sec4 #c4 ,regulation of in vitro clinical tests4 ,,subchapter ,j--,in ,vitro ,clinical ,tests ,,subchapter ,j4 ,in ,vitro ,clinical ,tests,sec4 #ehg4 ,definitions4 ,sec4 #ehg;,a4 ,applicability4 ,sec4 #ehg;,b4 ,premarket review4 ,sec4 #ehg;,c4 ,breakthrough in vitro clinical tests4 ,sec4 #ehg;,d4 ,technology certification4 ,sec4 #ehg;,e4 ,mitigating measures4 ,sec4 #ehg;,f4 ,regulatory pathway redesignation4 ,sec4 #ehg;,g4 ,advisory committees4 ,sec4 #ehg;,h4 ,request for informal feedback4 ,sec4 #ehg;,i4 ,registration and listing4 ,sec4 #ehg;,j4 ,test design and quality requirements4 ,sec4 #ehg,k4 ,labeling requirements4 ,sec4 #ehg,l4 ,adverse event reporting4 ,sec4 #ehg,m4 ,corrections and removals4 ,sec4 #ehg,n4 ,restricted in vitro clinical tests4 ,sec4 #ehg,o4 ,appeals4 ,sec4 #ehg,p4 ,accredited persons4 ,sec4 #ehg,q4 ,recognized standards4 ,sec4 #ehg,r4 ,investigational use4 ,sec4 #ehg,s4 ,collaborative communities for in vitro clinical tests4 ,sec4 #ehg,t4 ,comprehensive test information system4 ,sec4 #ehg,u4 ,preemption4 ,sec4 #ehg,v4 ,adulteration4 ,sec4 #ehg,w4 ,misbranding4 ,sec4 #ehg,x4 ,postmarket surveillance4 ,sec4 #ehg,y4 ,electronic format for submissions4 ,sec4 #ehg,z4 ,postmarket remedies4 ,sec4 #d4 ,enforcement and other provisions4 ,sec4 #e4 ,transition4 ,sec4 #f4 ,emergency use authorization4 ,sec4 #g4 ,antimicrobial susceptibility tests4 ,sec4 #h4 ,combination products4 ,sec4 #i4 ,resources4 4 #b4 ,definitions 7a7 ,in general ,section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7 is amended-- 7#a7 by adding at the end the following3 7ss7 7#a7 ,the term in vitro clinical test-- 7,a7 means a test intended by its developer 7as defined in section #ehg7 to be used in the collection1 preparation1 analysis1 or in vitro clinical examination of specimens taken or derived from the human body for the purpose of-- 7i7 identifying or diagnosing a disease or condition2 7ii7 providing information for diagnosing1 screening1 measuring1 detecting1 predicting1 prognosing1 analyzing1 or monitoring a disease or condition1 including by making a determination of an individual's state of health2 or 7iii7 selecting1 monitoring1 or informing therapy or treatment for a disease or condition2 and 7,b7 may include-- 7i7 a test protocol or laboratory test protocol2 7ii7 an instrument 7as defined in section #ehg7aa772 7iii7 an article for taking1 deriving1 holding1 or transporting specimens from the human body 7as defined in section #ehg7af772 7iv7 software1 excluding software that is excluded by section #ebj7o7 from the definition of a device under section #bja7;h71 and excluding modifications that are exempt in accordance with section #ehg;,a7l77#b77;,a72 and 7v7 subject to subparagraph 7#b71 a component or part of a test1 a test protocol1 an instrument1 an article1 or software described in any of clauses 7,a7 through 7,d7 of such subparagraph1 whether alone or in combination1 including reagents1 calibrators1 and controls4 7#b7 ,notwithstanding subparagraph 7#a77v71 an article intended to be used as a component or part of an in vitro clinical test described in subparagraph 7#a7 is excluded from the definition in subparagraph 7#a7 if the article consists of any of the following3 7,a7 ,blood1 blood components1 or human cells or tissues1 from the time of acquisition1 donation1 or recovery of such article1 including determination of donor eligibility1 as applicable1 until such time as the article is released as a component or part of an in vitro clinical test by the establishment that collected such article4 7,b7 ,an article used for invasive sampling1 a needle1 or a lancet1 except to the extent such article1 needle1 or lancet is an integral component of an article for holding1 storing1 or transporting a specimen4 7,c7 ,general purpose laboratory equipment1 including certain pre-analytical equipment1 as determined by the ,secretary4 7,d7 ,an article used solely for personal protection during the administering1 conducting1 or otherwise performing of test activities4 2 7#b7 by adding at the end of section #bja7;g7 the following3 7#c7 ,the term drug does not include an in vitro clinical test4 2 and 7#c7 in section #bja7;h71 by striking section #ebj7o7 and inserting section #ebj7o7 or an in vitro clinical test4 7b7 ,exclusion from definition of biological product ,section #cea7;i77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;i77#a77 is amended-- 7#a7 by striking 7#a7 ,the term biological product means and inserting 7#a77;,a7 ,the term biological product means2 and 7#b7 by adding at the end the following3 7,b7 ,the term biological product does not include an in vitro clinical test as defined in section #bja7ss7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act4 4 7c7 ,in vitro clinical test definition ,in this ,act1 the term in vitro clinical test has the meaning given such term in section #bja7ss7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a74 #c4 ,regulation of in vitro clinical tests ,the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq47 is amended-- 7#a7 by amending the heading of chapter ,v to read as follows3 ,drugs1 ,devices1 and ,in ,vitro ,clinical ,tests2 and 7#b7 by adding at the end of chapter ,v the following3 ,j ,in ,vitro ,clinical ,tests #ehg4 ,definitions ,in this subchapter3 7#a7 ,analytical validity 7,a7 ,the term analytical validity means1 with respect to an in vitro clinical test1 the ability of the in vitro clinical test1 to-- 7i7 sufficiently identify1 measure1 detect1 calculate1 or analyze one or more analytes1 biomarkers1 substances1 or other targets intended to be identified1 measured1 detected1 calculated1 or analyzed by the test2 or 7ii7 as applicable1 assist in such identification1 measurement1 detection1 calculation1 or analysis4 7,b7 ,for an article for taking or deriving specimens from the human body described in section #bja7ss77#a77;,b77iii71 the term analytical validity means that such article performs as intended and will support the analytical validity of an in vitro clinical test with which it is used4 7#b7 ,applicable standard ,the term applicable standard1 with respect to an in vitro clinical test1 means a reasonable assurance of analytical and clinical validity1 except that such term-- 7,a7 with respect to test instruments1 means a reasonable assurance of analytical validity2 and 7,b7 with respect to articles for taking or deriving specimens from the human body for purposes described in clause 7i7 or 7ii7 of section #bja7ss77#a77;,a7 means a reasonable assurance of analytical validity and1 where applicable1 safety4 7#c7 ,clinical use ,the term clinical use means the operation1 application1 or functioning of an in vitro clinical test in connection with human specimens1 including patient1 consumer1 and donor specimens1 for the purpose for which it is intended as described in section #bja7ss77#a77;,a74 7#d7 ,clinical validity ,the term clinical validity means the ability of an in vitro clinical test to achieve the purpose for which it is intended as described in section #bja7ss77#a77;,a74 7#e7 ,cross-referenced test ,the term cross-referenced test means an in vitro clinical test that references in its labeling the name or intended use of another medical product that is not an in vitro clinical test4 7#f7 ,develop ,the term develop1 with respect to an in vitro clinical test1 means-- 7,a7 designing1 validating1 producing1 manufacturing1 remanufacturing1 propagating1 or assembling an in vitro clinical test2 7,b7 importing an in vitro clinical test2 7,c7 modifying an in vitro clinical test initially developed by a different person in a manner that-- 7i7 changes any of the listing elements that define indications for use specified in paragraph 7#aj71 performance claims1 or1 as applicable1 the safety of such in vitro clinical test2 or 7ii7 affects the analytical or clinical validity of the in vitro clinical test as intended by the developer2 or 7,d7 adopting1 using1 or disseminating for use as an in vitro clinical test an article not previously intended for clinical use4 7#g7 ,developer ,the term developer means a person who engages in an activity described in paragraph 7#f7 for clinical use4 7#h7 ,first of a kind ,the term first-of-a-kind means1 with respect to an in vitro clinical test1 a test that has an intended use and a combination of the elements specified in paragraph 7#aj7 that differ from the intended use and such elements of other in vitro clinical tests that already are legally available in the ,united ,states4 7#i7 ,high-risk 7,a7 ,in general ,subject to subparagraph 7,b71 the term high-risk1 with respect to an in vitro clinical test or category of in vitro clinical tests1 means that an undetected inaccurate result from such test or category-- 7i7 presents potential unreasonable risk for serious or irreversible harm or death to a patient or patients1 or would otherwise cause serious harm to the public health2 or 7ii7 is potentially likely to result in the absence1 delay1 or discontinuation of life-supporting or life-sustaining medical treatment4 7,b7 ,exception ,the term high-risk does not include an in vitro clinical test described in subparagraph 7,a7 if mitigating measures are established and applied to sufficiently mitigate the risk of inaccurate results as described in subparagraph 7,a71 including-- 7i7 the degree to which the technology for the intended use of the in vitro clinical test is well-characterized1 and the criteria for performance of the test are well-established to be sufficient for the intended use2 and 7ii7 the clinical circumstances under which the in vitro clinical test is used1 and the availability of other tests 7such as confirmatory or adjunctive tests7 or relevant material standards4 7#aj7 ,indications for use ,the term indications for use means one or more in vitro clinical tests that have all of the following notification elements in common3 7,a7 ,substance or substances measured by the in vitro clinical test1 such as an analyte1 protein1 or pathogen4 7,b7 ,test method4 7,c7 ,test purpose or purposes1 as described in section #bja7ss77#a77;,a74 7,d7 ,diseases or conditions for which the in vitro clinical test is intended for use1 including intended patient populations4 7,e7 ,context of use1 such as in a clinical laboratory1 in a health care facility1 prescription home use1 over-the-counter use1 or direct-to-consumer testing4 7#aa7 ,instrument ,the term instrument means an in vitro clinical test that is hardware intended by the hardware's developer to be used with one or more in vitro clinical tests to generate a clinical test result1 including software used to effectuate the hardware's functionality4 7#ab7 ,instrument family ,the term instrument family means more than one instrument for which the developer demonstrates and documents1 with respect to all such instruments1 that all-- 7,a7 have the same basic architecture1 design1 and performance characteristics1 such as tolerance limits and signal range2 7,b7 have the same intended use or uses and function2 7,c7 share the same measurement principles1 detection methods1 and reaction conditions2 and 7,d7 produce the same or similar analytical results from samples of the same specimen type or types4 7#ac7 ,laboratory operations ,the term laboratory operations-- 7,a7 means the conduct of a laboratory examination or other laboratory procedure on materials derived from the human body1 including the conduct of an in vitro clinical test and associated activities within or under the oversight of a laboratory and not related to the design of an in vitro clinical test2 and 7,b7 includes-- 7i7 performing pre-analytical and post-analytical processes for an in vitro clinical test2 7ii7 conducting standard operating procedures2 and 7iii7 preparing reagents or other test materials that do not meet the definition of a in vitro clinical test for clinical use under section #bja7ss74 7#ad7 ,low-risk ,the term low-risk1 with respect to an in vitro clinical test or category of in vitro clinical tests1 means that-- 7,a7 an undetected inaccurate result from such in vitro clinical test1 or such category of in vitro clinical tests1 when used as intended-- 7i7 would cause minimal or no harm1 or minimal or no disability1 or immediately reversible harm1 or would lead to only a remote risk of adverse patient impact or adverse public health impact2 or 7ii7 could cause non-life threatening injury1 harm that is medically reversible1 or a delay in necessary treatment2 or 7,b7 mitigating measures are sufficient to ensure the test meets the requirements of subparagraph 7,a7 7#ae7 ,mitigating measures ,the term mitigating measures-- 7,a7 means requirements that the ,secretary determines1 based on available evidence1 are necessary-- 7i7 for an in vitro clinical test1 or a category of in vitro clinical tests1 to meet the applicable standard2 or 7ii7 to mitigate the risk of harm ensuing from an inaccurate result or misinterpretation of any result2 and 7,b7 includes1 as appropriate1 applicable requirements regarding labeling1 performance standards1 performance testing1 submission of clinical data1 advertising1 website posting of information1 clinical studies1 postmarket surveillance1 user comprehension studies1 training1 and conformance to standards4 7#af7 ,specimen receptacle ,the term specimen receptacle means an in vitro clinical test specifically intended for the holding1 storing1 or transporting of specimens derived from the human body or for in vitro examination for purposes described in clause 7i7 or 7ii7 of section #bja7ss77#a77;,a74 7#ag7 ,technology ,the term technology-- 7,a7 means a developer's grouping of in vitro clinical tests that do not significantly differ in control mechanisms1 energy sources1 or operating principals and for which design1 development1 and manufacturing1 including analytical and clinical validation as applicable1 of the tests would be addressed in a similar manner or through similar procedures2 and 7,b7 may include clot detection1 colorimetric 7non-immunoassay71 electrochemical 7non-immunoassay71 enzymatic 7non-immunoassay71 flow cytometry1 fluorometry 7non-immunoassay71 immunoassay1 mass spectrometry or chromatography 7such as ,,hplc71 microbial culture1 next generation sequencing 7also known as ,,ngs71 nephlometric or turbidimetric 7non-immunoassay71 singleplex or multiplex non-,,ngs nucleic acid analysis1 single-based technology1 spectroscopy1 and any other technology1 as the ,secretary determines appropriate4 7#ah7 ,test ,the term test1 unless otherwise provided1 means an in vitro clinical test4 7#ai7 ,valid scientific evidence ,the term valid scientific evidence-- 7,a7 means1 with respect to an in vitro clinical test1 evidence-- 7i7 that has been generated and evaluated by persons qualified by training or experience to do so1 using procedures generally accepted by other persons so qualified2 and 7ii7 from which it can be fairly and responsibly concluded by qualified experts whether the applicable standard has been met by the in vitro clinical test for its intended use2 and 7,b7 may include evidence described in subparagraph 7,a7 consisting of-- 7i7 peer-reviewed literature2 7ii7 clinical guidelines2 7iii7 reports of significant human experience with an in vitro clinical test2 7iv7 bench studies2 7v7 case studies or histories2 7vi7 clinical data2 7vii7 consensus standards2 7viii7 reference standards2 7ix7 data registries2 7x7 postmarket data2 7xi7 real world data2 7xii7 clinical trials2 and 7xiii7 data collected in countries other than the ,united ,states if such data are demonstrated to be adequate for the purpose of making a regulatory determination under the applicable standard in the ,united ,states4 7#bj7 ,well-characterized ,the term well-characterized1 with respect to an in vitro clinical test1 means well-established and well-recognized by the scientific or clinical community1 if adequately evidenced by one or more of the following3 7,a7 ,peer-reviewed literature4 7,b7 ,practice guidelines4 7,c7 ,consensus standards4 7,d7 ,recognized standards of care4 7,e7 ,technology in use for many years4 7,f7 ,scientific publication by multiple sites4 7,g7 ,adoption by the scientific or clinical community4 7,h7 ,real world data4 #ehg;,a4 ,applicability 7a7 ,in general 7#a7 ,applicability of this subchapter 7,a7 ,in general ,an in vitro clinical test shall be subject to the requirements of this subchapter1 except as otherwise provided this subchapter4 7,b7 ,interstate commerce ,any in vitro clinical test that is offered for clinical use in the ,united ,states is deemed to be introduced into interstate commerce for purposes of enforcing the requirements of this ,act4 7,c7 ,non-applicable requirement ,subject to any exemption or exclusion in this section1 an in vitro clinical test shall not be subject to any provision or requirement of this ,act other than this subchapter unless such other provision or requirement-- 7i7 applies expressly to in vitro clinical tests2 or 7ii7 describes the authority of the ,secretary when regulating such in vitro clinical tests or subset of in vitro clinical tests1 with respect to-- 7,i7 all articles regulated by the ,secretary pursuant to this ,act2 or 7,,ii7 a subset of such articles that includes in vitro clinical tests4 7#b7 ,laboratories and blood and tissue establishments 7,a7 ,relation to laboratory certification pursuant to section #cec of the ,,phsa ,nothing in this subchapter shall be construed to modify the authority of the ,secretary with respect to laboratories or clinical laboratories under section #cec of the ,public ,health ,service ,act4 7,b7 ,avoiding duplication ,in implementing this subchapter1 the ,secretary shall avoid issuing or enforcing regulations that are duplicative of regulations under section #cec4 7,c7 ,blood and tissue ,nothing in this subchapter shall be construed to modify the authority of the ,secretary with respect to laboratories1 establishments1 or other facilities to the extent they are engaged in the propagation1 manufacture1 or preparation1 including filling1 testing1 labeling1 packaging1 and storage1 of blood1 blood components1 human cells1 tissues1 or tissue products under this ,act or section #cea or #cfa of the ,public ,health ,service ,act4 7#c7 ,practice of medicine 7,a7 ,in general ,nothing in this subchapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed in vitro clinical test for any condition or disease within a health care practitioner-patient relationship pursuant to applicable ,federal or ,state law4 7,b7 ,rules of construction 7i7 ,sale1 distribution1 labeling ,nothing in this paragraph shall be construed to limit the authority of the ,secretary to establish or enforce restrictions on the sale1 distribution1 or labeling of an in vitro clinical test under this ,act4 7ii7 ,promotion of unapproved uses ,nothing in this paragraph shall be construed to alter any prohibition on the promotion of unapproved uses of legally marketed in vitro clinical tests4 7#d7 ,special rule 7,a7 ,premarket review applicable ,notwithstanding the exemptions from premarket review under section #ehg;,b set forth in subsections 7b71 7c71 7d71 7e71 7f71 7g71 7h71 7j71 and 7k7 an in vitro clinical test 7including any article for taking or deriving specimens7 shall be subject to the requirements of section #ehg;,b if the ,secretary determines1 in accordance with subparagraph 7,b71 that-- 7i7 7,i7 there is insufficient valid scientific evidence to support the analytical validity or the clinical validity of such in vitro clinical test2 and 7,,ii7 such in vitro clinical test is being offered by its developer with materially deceptive or fraudulent analytical or clinical claims2 7ii7 it is reasonably possible that such in vitro clinical test will cause serious adverse health consequences2 or 7iii7 in the case of specimen receptacles1 there is sufficient valid scientific evidence indicating that a specimen receptacle did not perform as intended1 will not support the analytical validity of tests with which it is used1 or as applicable1 is not safe for use4 7,b7 ,process 7i7 ,request for information ,if the ,secretary has valid scientific evidence indicating that the criteria listed in subparagraph 7,a7 apply to an in vitro clinical test1 the ,secretary may request that the developer of the test submit information-- 7,i7 pertaining to such criteria2 and 7,,ii7 establishing the basis for any claimed exemption from premarket review4 7ii7 ,deadline for submitting information ,upon receiving a request for information under clause 7i71 the developer of an in vitro clinical test shall submit the information within #cj days of such receipt4 7iii7 ,review deadline ,upon receiving a submission under clause 7ii71 the ,secretary shall-- 7,i7 review the submitted information within #fj calendar days of such receipt2 and 7,,ii7 determine whether the criteria listed in subparagraph 7,a7 apply to the in vitro clinical test4 7iv7 ,premarket review required 7,i7 ,in general ,if the ,secretary finds that the criteria listed in subparagraph 7,a7 apply to the in vitro clinical test1 the developer shall-- 7aa7 promptly1 and not later than #ij days after the date of receipt of such information1 submit an application for premarket review of the test under section #ehg;,b2 or 7bb7 cease to market the test4 7,,ii7 ,extension ,the ,secretary may grant an extension to a developer of the #ij-;day time period under subclause 7,i77aa71 as appropriate4 7v7 ,continued marketing ,during the period beginning on the date of a request for information under clause 7ii7 and ending on the date of the disposition of an application for premarket review of the in vitro clinical test under section #ehg;,b1 the developer of the test may continue to market the test for clinical use1 unless the ,secretary issues an order to the developer under clause 7vi7 to immediately cease distribution of the test4 7vi7 ,order to cease distribution 7,i7 ,in general ,if the developer of an in vitro clinical test fails to submit an application for premarket review of the test by the deadline applicable under clause 7iv71 or the ,secretary finds that the criteria listed in subparagraph 7,a7 apply to an in vitro clinical test and that it is in the best interest of the public health1 the ,secretary may issue an order1 within #aj calendar days of the applicable deadline or finding by the ,secretary1 requiring the developer of such in vitro clinical test1 and any other appropriate person 7including a distributor or retailer of the in vitro clinical test7 to immediately-- 7aa7 cease distribution of the test pending approval of an application for premarket review of the test under section #ehg;,b2 and 7bb7 notify health professionals and other user facilities of the order to cease distribution and advise health care professionals to cease use of such in vitro clinical test4 7,,ii7 ,hearing and review ,an order under subclause 7,i7 shall provide the person subject to the order with an opportunity for an informal hearing1 to be held not later than #aj days after the date of the issuance of the order1 on the actions required by the order and on whether the order should be amended to require a recall of such in vitro clinical test4 ,if1 after providing an opportunity for such a hearing1 the ,secretary determines that inadequate grounds exist to support the actions required by the order1 the ,secretary shall terminate the order within #cj days of the hearing4 ,upon terminating an order1 the ,secretary shall provide written notice of such termination to the developer4 7vii7 ,amendment to require recall ,if the ,secretary determines that an order issued under clause 7vi7 should be amended to include a recall of the in vitro clinical test with respect to which the order was issued1 the ,secretary shall amend the order to require a recall4 ,in such amended order1 the ,secretary shall specify a timetable in which the in vitro clinical test recall will occur and shall require periodic reports to the ,secretary describing the progress of the recall4 ,upon termination of the recall1 the ,secretary shall provide written notice of such termination to the developer4 7viii7 ,effect of test approval ,any order issued under this paragraph with respect to an in vitro clinical test shall cease to be in effect if such test is granted approval under section #ehg;,b1 provided that the in vitro clinical test is developed and offered for clinical use in accordance with such approval4 7#e7 ,emergency use 7,a7 ,in general ,in the case of a public health emergency under section #cai of the ,public ,health ,service ,act1 an in vitro clinical test is exempt from the requirements of this subchapter and may be lawfully marketed in accordance with subparagraph 7,b74 7,b7 ,criteria ,an in vitro clinical test may be lawfully marketed in accordance with the exemption described in subparagraph 7,a7 if such test-- 7i7 is authorized for an emergency use under section #efd7;b72 or 7ii7 is developed and used in laboratories for which a certificate is in effect under section #cec of the ,public ,health ,service ,act to conduct high-complexity testing and the developer-- 7,i7 is pursuing an emergency use authorization under section #efd and provides updates to the ,secretary on efforts to pursue such authorization2 7,,ii7 validates such in vitro clinical test prior to use2 7,,iii7 notifies the ,secretary of the assay validation2 and 7,,iv7 includes a statement together with the results of the test that reads3 ,this ,,ivct was developed for use as a part of a response to a public health emergency4 ,this test has not been reviewed by the ,food and ,drug ,administration44 7,c7 ,disposition of product ,with respect to a previously unapproved in vitro clinical test or an in vitro clinical tests with an unapproved use1 for which an emergency use authorization under section #efd7;b7 ceases to be effective1 the ,secretary shall consult with the manufacturer of such product with respect to the appropriate disposition of the product4 7,d7 ,streamlining of application review ,a developer may include any data or information already submitted to the ,secretary within the emergency use authorization as a part of a premarket application under section #ehg;,b or a technology certification application under section #ehg;,d4 7b7 ,components and ,parts 7#a7 ,exemption 7,a7 ,in general ,subject to subparagraph 7,b71 a component1 part1 or raw material described in section #bja7ss77#a77;,f7 is exempt from the requirements of this subchapter if it is-- 7i7 intended for further development as described in paragraph 7#b72 or 7ii7 is otherwise to be regulated based on its risk when used as intended by the developer1 notwithstanding its subsequent use by a developer as a component1 part1 or raw material of another in vitro clinical test4 7,b7 ,inapplicability to other tests ,notwithstanding subparagraph 7,a71 an in vitro clinical test that is described in section #bja7ss77#a77;,b7 and that uses a component or part described in such subparagraph shall be subject to the requirements of this subchapter1 unless the test is otherwise exempted under this section4 7#b7 ,further development ,a component1 part1 or raw material 7as described in paragraph 7#a77;,a77 is intended for further development 7for purposes of such paragraph7 if-- 7,a7 it is intended solely for use in the development of another in vitro clinical test2 and 7,b7 in the case of such a test that is introduced or delivered for introduction into interstate commerce after the date of enactment of the ,verifying ,accurate ,leading-edge ,,ivct ,development ,act of #bjbj1 the labeling of such test bears the following statement3 ,this product is intended solely for further development of an in vitro clinical test and is exempt from ,,fda regulation4 ,this product must be evaluated by the in vitro clinical test developer if it is used with or in the development of an in vitro clinical test44 7c7 ,grandfathered tests 7#a7 ,exemption ,an in vitro clinical test that meets the criteria set forth in paragraph 7#b7 is exempt from the requirements of this subchapter1 except as provided under section #ehg;,a7a77#d71 the registration and listing requirements under section #ehg;,i1 and the adverse reporting requirements under section #ehg,l1 and may be lawfully marketed subject to the other applicable requirements of this ,act1 if-- 7,a7 each test report template for the test bears a statement of adequate prominence that reads as follows3 ,this in vitro clinical test was developed and first introduced prior to the date of enactment of the ,verifying ,accurate ,leading-edge ,,ivct ,development ,act of #bjbj and has not been reviewed by the ,food and ,drug ,administration42 and 7,b7 the developer of the test-- 7i7 maintains documentation demonstrating that the test meets and continues to meet the criteria set forth in paragraph 7#b72 and 7ii7 makes such documentation available to the ,secretary upon request4 7#b7 ,criteria for exemption ,an in vitro clinical test is exempt as specified in paragraph 7#a7 if the test-- 7,a7 7i7 was first offered for clinical use by such laboratory before the date of enactment of the ,verifying ,accurate ,leading-edge ,,ivct ,development ,act of #bjbj2 7ii7 was developed by a clinical laboratory for which a certificate is in effect under section #cec of the ,public ,health ,service ,act that meets the requirements under section #cec for performing high-complexity testing2 and 7iii7 is performed-- 7,i7 in the same clinical laboratory in which it was developed2 7,,ii7 by another clinical laboratory for which a certificate is in effect under section #cec within the same corporate organization and having common ownership by the same parent corporation2 or 7,,iii7 by a laboratory within a public health laboratory network coordinated or managed by the ,centers for ,disease ,control and ,prevention2 7,b7 does not have in effect an approval under section #eae1 a clearance under section #eaj7k71 an authorization under section #eac7;f77#b71 or an approval under section #ebj7m72 and 7,c7 is not modified on or after the date of enactment of the ,verifying ,accurate ,leading-edge ,,ivct ,development ,act of #bjbj by its initial developer 7or another person7 in a manner such that the test is a new in vitro clinical test under subsection 7l74 7#c7 ,modifications ,in the case of a modification to an vitro clinical test that is exempt as specified in paragraph 7#a7 or determines that such modification is otherwise not subject to premarket review pursuant to section #ehg;,a7l71 the test continues to qualify for such exemption if the person modifying such test-- 7,a7 documents each such modification and maintains a summary of the basis for such determination2 and 7,b7 provides such documentation and summary to the ,secretary upon request or inspection4 7d7 ,tests exempt from section #eaj7k7 7#a7 ,exemption ,an in vitro clinical test is exempt from premarket review under section #ehg;,b and may be lawfully marketed subject to the other applicable requirements of this ,act1 if the in vitro clinical test-- 7,a7 7i7 was offered for clinical use prior to the date of enactment of the ,verifying ,accurate ,leading-edge ,,ivct ,development ,act of #bjbj2 and 7ii7 immediately prior to such date of enactment was exempt pursuant to subsection 7l7 or 7m77#b7 of section #eaj from the requirements for submission of a report under section #eaj7k72 or 7,b7 7i7 was not offered for clinical use prior to such date of enactment2 7ii7 is not a test platform2 and 7iii7 falls within a category of tests that was exempt from the requirements for submission of a report under section #eaj7k7 as of such date of enactment 7including class ,,ii devices and excluding class ,i devices described in section #eaj7l774 7#b7 ,effect on special controls ,for any in vitro clinical test1 or category of in vitro clinical tests1 that is exempt from premarket review based on the criteria in paragraph 7#b71 any special control that applied to a device within a predecessor category immediately prior to the date of enactment of ,verifying ,accurate ,leading-edge ,,ivct ,development ,act of #bjbj shall be deemed a mitigating measure applicable under section #ehg;,e to an in vitro clinical test within the successor category1 except to the extent such mitigating measure is withdrawn or changed in accordance with section #ehg;,e4 7#c7 ,near-patient testing ,not later than #a year after the date of enactment of the ,verifying ,accurate ,leading-edge ,,ivct ,development ,act of #bjbj1 the ,secretary shall issue draft guidance indicating categories of tests that shall be exempt from premarket review under section #ehg;,b when offered for near-patient testing 7point of care71 which were not exempt from submission of a report under section #eaj7k7 pursuant to subsection 7l7 or 7m77#b7 of section #eaj and regulations imposing limitations on exemption for in vitro devices intended for near-patient testing 7point of care74 7e7 ,low-,risk tests 7#a7 ,exemption ,an in vitro clinical test is exempt from premarket review under section #ehg;,b and may be lawfully marketed subject to the other applicable requirements of this ,act1 including section #ehg;,i7b77#f71 if such test meets the definition of low-risk under section #ehg4 7#b7 ,list of low-risk tests 7,a7 ,in general ,the ,secretary shall maintain1 and make publicly available on the website of the ,food and ,drug ,administration1 a list of in vitro clinical tests1 and categories of in vitro clinical tests1 that are low-risk in vitro clinical tests for purposes of the exemption under this subsection4 7,b7 ,inclusion ,the list under subparagraph 7,a7 shall consist of-- 7i7 all in vitro clinical tests and categories of in vitro clinical tests that are exempt from premarket review pursuant to subsection 7d77#a7 or 7d77#c72 and 7ii7 all in vitro clinical tests and categories of in vitro clinical tests that are designated by the ,secretary pursuant to subparagraph 7,c7 as low-risk for purposes of this subsection4 7,c7 ,designation of tests and categories ,without regard to subchapter ,,ii of chapter #e of title #e1 ,united ,states ,code1 the ,secretary may designate1 in addition to the tests and categories described in subparagraph 7,b77i71 additional in vitro clinical tests1 and categories of in vitro clinical tests1 as low-risk in vitro clinical tests for purposes of the exemption under this subsection4 ,the ,secretary may make such a designation on the ,secretary's own initiative or in response to a request by any person4 ,in making such a designation for a test or category of tests1 the ,secretary shall consider-- 7i7 whether the test1 or category of tests1 is low-risk 7as defined in section #ehg72 and 7ii7 such other factors as the ,secretary determines to be relevant to the protection of the public health4 7f7 ,manual tests 7#a7 ,exemption ,an in vitro clinical test is exempt from all requirements of this subchapter if the output of such in vitro clinical test is the result of direct1 manual observation1 without the use of automated instrumentation or software for intermediate or final interpretation1 by a qualified laboratory professional1 and such in vitro clinical test-- 7,a7 is designed1 manufactured1 and used within a single clinical laboratory for which a certificate is in effect under section #cec of the ,public ,health ,service ,act that meets the requirements under section #cec for performing high-complexity testing2 7,b7 is not a high-risk test1 or is a high-risk test that the ,secretary has determined meets at least one condition in paragraph 7#b7 and is otherwise appropriate for this exemption2 and 7,c7 is not intended for testing donors1 donations1 and recipients of blood1 blood components1 human cells1 tissues1 cellular-based products1 or tissue-based products4 7#b7 ,high-risk test limitation or condition ,a high-risk test may be exempt under paragraph 7#a7 from the requirements of this subchapter only if-- 7,a7 no component or part of such test1 including any reagent1 is introduced into interstate commerce under the exemption under subsection 7b77#a7 7relating to components or parts intended for further development71 and any article for taking or deriving specimens from the human body used in conjunction with the test remains subject to the requirements of this subchapter2 or 7,b7 the test has been developed in accordance with the applicable test design and quality requirements under section #ehg;,j4 7g7 ,humanitarian test exemption 7#a7 ,in general ,an in vitro clinical test is exempt from premarket review under section #ehg;,b and may be lawfully marketed subject to the other applicable requirements of this ,act1 if-- 7,a7 such in vitro clinical test-- 7i7 is intended for use for a disease or condition for which no more than #aj1jjj 7or such other number determined by the ,secretary7 individuals would be subject to negative or positive diagnosis by such test in the ,united ,states per year2 and 7ii7 is not intended to diagnose a contagious disease or condition that is highly likely to result in fatal or irreversibly debilitating outcome and for which prompt and accurate diagnosis offers the opportunity to mitigate a public health impact of the condition2 and 7,b7 the developer of the test-- 7i7 maintains documentation 7which may include literature citations in specialized medical journals1 textbooks1 specialized medical society proceedings1 governmental statistics publications1 or1 if no such studies or literature citations exist1 credible conclusions from appropriate research or surveys7 demonstrating that such test meets and continues to meet the criteria described in this paragraph2 and 7ii7 makes such documentation available to the ,secretary upon request4 7#b7 ,cross-referenced tests ,in order to be eligible for an exemption under this subsection1 the developer of a cross-referenced test shall submit a request under section #ehg;,h for informal feedback4 7h7 ,custom tests and low-,volume tests ,an in vitro clinical test is exempt from premarket review under section #ehg;,b1 the quality requirements under section #ehg;,j1 and the notification requirements under section #ehg;,i1 and may be lawfully marketed subject to the other applicable requirements of this ,act1 if-- 7#a7 such in vitro clinical test-- 7,a7 is a low-volume test performed in a laboratory in which it was developed or developed in a laboratory within the same corporate organization with the laboratory in which such test is performed and is administered to no more than #e patients per year1 unless otherwise determined by the ,secretary2 or 7,b7 is a custom test developed or modified to diagnose a unique pathology or physical condition of a specific patient for which no other in vitro clinical test is commercially available in the ,united ,states1 and is-- 7i7 not intended for use with respect to other patients2 and 7ii7 after the development of the custom test1 not included in any test menu1 template test report1 or other promotional materials1 and not otherwise advertised2 and 7#b7 the developer of the test-- 7,a7 maintains documentation demonstrating that such test meets and continues to meet the applicable criteria described in paragraph 7#a72 7,b7 makes such documentation1 such as a prescription order requesting the custom test for an individual patient1 available to the ,secretary upon request2 and 7,c7 informs the ,secretary1 on an annual basis1 in a manner prescribed by the ,secretary by guidance1 that such test was introduced into interstate commerce4 7i7 ,public health surveillance activities 7#a7 ,in general ,the provisions of this subchapter shall not apply to a test intended by the developer to be used solely for public health surveillance activities1 including the collection and testing of information or biospecimens1 conducted1 supported1 requested1 ordered1 required1 or authorized by a public health authority4 7#b7 ,limitation ,such activities-- 7,a7 are limited to those necessary to allow a public health authority to identify1 monitor1 assess1 or investigate potential public health signals1 onsets of disease outbreaks1 or conditions of public health importance 7including trends1 risk factors1 patterns in diseases1 or increases in injuries from using consumer products72 and 7,b7 include those associated with providing timely situational awareness and priority setting during the course of a threat to the public health 7including natural or man-made disasters and deliberate attacks on the ,united ,states74 7#c7 ,exclusion ,an in vitro clinical test is not excluded from the provisions of this subchapter if such test is intended for use in making clinical decisions for individual patients4 7j7 ,law enforcement or employer testing ,an in vitro clinical test that is intended solely for use in forensic analysis1 law enforcement activity1 or employment purposes is exempt from the requirements of this ,act4 ,an in vitro clinical test that is intended for use in making clinical decisions for individual patients1 or whose individually identifiable results may be reported back to an individual patient or the patient's health care provider1 even if also intended for law enforcement or employment testing purposes1 is not intended solely for use in law enforcement or employment testing for purposes of this subsection4 7k7 ,in vitro clinical tests under a technology certification order ,an in vitro clinical test that is within the scope of a technology certification order1 as described in section #ehg;,d7a77#b71 is exempt from premarket review under section #ehg;,b4 7l7 ,modified tests 7#a7 ,in general ,an in vitro clinical test that is modified1 by the initial developer of the test or a different person1 is a new in vitro clinical test subject to the requirements of this subchapter if the modification-- 7,a7 affects the analytical or clinical validity of such test2 7,b7 causes the test to no longer comply with applicable mitigating measures under section #ehg;,e or restrictions under section #ehg,n2 or 7,c7 as applicable1 affects the safety of an article for taking or deriving specimens from the human body for a purpose described in section #bja7ss77#a74 7#b7 ,exemptions ,notwithstanding paragraph 7#a71 an in vitro clinical test that is modified by the initial developer of the test or a different person is not a new in vitro clinical test if the modification-- 7,a7 is a software update that does not have an adverse effect on the analytical or clinical validity or result in an increased risk to patients and consumers2 7,b7 is made pursuant to methods or criteria included in the change protocol premarket submission1 amendment1 or supplement approved by the ,secretary for the in vitro clinical test being modified2 7,c7 is a labeling change that is appropriate to address patient or user harm2 or 7,d7 is a specimen-related modification that is made to extend specimen stability or aligns with the data and information submitted in an approved application for premarket review under section #ehg;,b or an order issued under section #ehg;,d4 7#c7 ,documentation ,when a person modifies an in vitro clinical test that was developed by another person1 such modified test is exempt from the requirements of this subchapter provided that such person-- 7,a7 documents the modification that was made and the basis for determining that the modification1 considering the changes individually and collectively1 was not a type of modification described in paragraph 7#a72 and 7,b7 provides such documentation to the ,secretary upon request or inspection4 7m7 ,investigational use ,an in vitro clinical test for investigational use is exempt from the requirements of this ,act1 except as provided in section #ehg,r4 7n7 ,transfer or sale of ,in vitro clinical tests 7#a7 ,transfer and assumption of regulatory obligations ,if ownership of an in vitro clinical test is sold or transferred in such manner that the developer transfers the regulatory submissions and obligations applicable under this subchapter with respect to the test1 the transferee or purchaser becomes the developer of the test and shall have all regulatory obligations applicable to such a test under this subchapter4 ,the transferee or purchaser shall update the registration and listing information under section #ehg;,i for the in vitro clinical test4 7#b7 ,transfer or sale of premarket approval 7,a7 ,notice required ,if a developer of an in vitro clinical test transfers or sells the approval of the in vitro clinical test1 the transferor or seller shall-- 7i7 submit a notice of the transfer or sale to the ,secretary and update the registration and listing information under section #ehg;,i for the in vitro clinical test2 and 7ii7 submit a supplemental application if required under section #ehg;,b7h74 7,b7 ,effective date of approval transfer ,a transfer or sale described in subparagraph 7,a7 shall become effective upon completion of a transfer or sale described in paragraph 7#a7 or the approval of a supplemental application under section #ehg;,b7h7 if required1 whichever is later4 ,the transferee or purchaser shall update the registration and listing information under section #ehg;,i for the in vitro clinical test within #ae calendar days of the effective date of the transfer or sale4 7#c7 ,transfer or sale of technology certification 7,a7 ,requirements for transfer or sale of technology certification ,an unexpired technology certification can be transferred or sold if the transferee or purchaser-- 7i7 is an eligible person under section #ehg;,d7b77#a72 and 7ii7 maintains1 upon such transfer or sale1 the site1 test design and quality requirements1 processes and procedures under the scope of technology certification1 and scope of the technology certification identified in the applicable technology certification order4 7,b7 ,notice required ,if a developer of an in vitro clinical test transfers or sells a technology certification order that has not expired1 the transferor or seller shall submit a notice of the transfer or sale to the ,secretary and shall update the registration and listing information under section #ehg;,i for all in vitro clinical tests covered by the technology certification4 7,c7 ,effective date of technology certification transfer ,the transfer of a technology certification shall become effective upon completion of a transfer or sale described in subparagraph 7,a74 ,the transferee or purchaser shall update the registration and listing information under section #ehg;,i for the in vitro clinical test within #cj calendar days of the effective date of the technology certification transfer4 7,d7 ,new technology certification required ,if the requirements of subclause 7,a77ii7 are not met1 then the technology certification order cannot be transferred and the transferee or purchaser of an in vitro clinical test must submit an application for technology certification and obtain a technology certification order prior to offering the test for clinical use4 7o7 ,general laboratory equipment ,any instrument that does not produce an analytical result1 and that functions as a component of pre-analytical procedures related to in vitro clinical tests1 is not subject to the requirements of this subchapter1 provided that-- 7#a7 the instrument is operating in a clinical laboratory that is certified under section #cec of the ,public ,health ,service ,act2 and 7#b7 the instrument can be serviced by the manufacturer of such instrument or1 if that manufacturer is no longer in business1 a third party with the ability to service such instrument4 7p7 ,instrument families ,in the case of an instrument family1 premarket approval under section #ehg;,b7d7 of one version of the in vitro clinical test is required1 and previous and updated versions of the same test within such instrument family shall be deemed to be subject to the approval pursuant to that section1 unless the ,secretary determines otherwise1 as set forth in guidance4 7q7 ,general exemption authority ,the ,secretary may1 by order published in the ,federal ,register following notice and an opportunity for comment1 exempt a class of persons from any section under this subchapter upon a finding that such exemption is appropriate for the protection of the public health and other relevant considerations4 7r7 ,regulations ,the ,secretary may issue regulations to implement this subchapter4 #ehg;,b4 ,premarket review 7a7 ,in general ,no person shall introduce or deliver for introduction into interstate commerce any in vitro clinical test1 unless-- 7#a7 an approval of an application filed pursuant to subsection 7c7 or 7d7 is effective with respect to test2 or 7#b7 the test is exempt under section #ehg;,a from premarket review under this section4 7b7 ,transparency and predictability 7#a7 ,pre-submission meeting or request for informal feedback ,pursuant to section #ehg;,h1 prior to filing an application under subsection 7c7 or 7d71 any person may request a meeting or written correspondence with the ,secretary to discuss the eligibility of an in vitro clinical test for premarket review or other information related to the filing of an application4 ,the ,secretary shall respond to such request within #de calendar days4 7#b7 ,streamlining of applications 7,a7 ,premarket application and technology certification ,if a person files a premarket application under this section and provides any additional documentation required under section #ehg;,d1 the in vitro clinical test that is the subject of the application may be utilized as the representative test reviewed by the ,secretary to provide an approval for both a premarket application under this section and a technology certification order under section #ehg;,d4 7,b7 ,representative assays for premarket approval ,with respect to a technology certification application filed under section #ehg;,d1 the representative test1 as described in subparagraph 7,a71 used to issue a technology certification order under section #ehg;,d shall be deemed a test with premarket approval under this section4 7c7 ,application 7#a7 ,filing ,any person may file with the ,secretary an application for premarket approval of an in vitro clinical test4 7#b7 ,application content ,an application submitted under paragraph 7#a7 with respect to an in vitro clinical test shall include the following1 in such format as the ,secretary specifies3 7,a7 ,general information regarding the in vitro clinical test1 including-- 7i7 the name and address of the applicant2 7ii7 the table of contents for the application and the identification of the information the applicant claims as trade secret or confidential commercial or financial information2 7iii7 a description of the test's intended use2 7iv7 an explanation regarding test function and any significant performance characteristics2 and 7v7 an explanation of how the development and validation activities support the test meeting the applicable standard4 7,b7 ,a summary of the data and information in the application for the in vitro clinical test1 including-- 7i7 a brief description of any existing alternative practices or procedures for diagnosing the disease or condition for which the in vitro clinical test is intended1 as applicable2 7ii7 a brief description of the foreign and domestic marketing history of the test1 if any1 including a list of all countries in which the test has been marketed and a list of all countries in which the test has been withdrawn from marketing for any reason related to the applicable standard of the in vitro clinical test1 if known by the applicant2 7iii7 a summary of the any studies submitted for such test1 including a description of the objective of the study1 a description of the experimental design of the study1 a brief description of how the data were collected and analyzed1 a brief description of the results of the technical data submitted1 and a brief description of any nonclinical or clinical studies2 7iv7 a risk assessment of the test2 and 7v7 conclusions drawn from any studies described in clause 7iii71 including a discussion demonstrating that the data and information in the application constitute valid scientific evidence and meet the applicable standard under section #ehg7aj71 an explanation of how the development and validation activities1 as applicable1 support that the test meets the applicable standard under section #ehg7aj71 and a discussion of any adverse effects of the test on health and proposals to mitigate those risks1 if any4 7,c7 ,the signature of the person filing the premarket application or an authorized representative4 7,d7 ,a bibliography of all published reports reasonably known to the applicant related to such test and a discussion of data and information relevant to the evaluation of the applicable standard that may be met by such test4 7,e7 ,a statement that the applicant believes to the best of the applicant's knowledge that all data and information submitted to the ,secretary are truthful and accurate and that no material fact has been omitted in the application4 7,f7 ,except as provided under subsection 7d71 applicable information regarding the methods used in1 or the facilities or controls used for1 the development of the test to demonstrate compliance with the applicable quality requirements under section #ehg;,j4 7,g7 ,information demonstrating compliance with any relevant-- 7i7 mitigating measures under section #ehg;,e2 and 7ii7 standards established or recognized under section #ead prior to the date of enactment of the ,verifying ,accurate ,leading-edge ,,ivct ,development ,act of #bjbj1 or1 after applicable standards are established or recognized under section #ehg,q1 with such standards4 7,h7 ,valid scientific evidence to support analytical and clinical validity of the test1 which shall include-- 7i7 summary information for all supporting validation studies performed2 and 7ii7 raw data1 such as tabulations of data and results as required under section #had4bj7;b77#f77;ii7 of title #ba1 ,code of ,federal ,regulations 7or any successor regulations72 7iii7 for nonclinical laboratory studies involving the test1 a statement that studies were conducted in compliance with applicable good laboratory practices2 and 7iv7 for investigations involving human subjects1 statements that any clinical investigation involving human subjects was conducted in compliance with applicable-- 7,i7 institutional review board regulations2 7,,ii7 informed consent regulations2 and 7,,iii7 investigational use requirements in section #ehg,r4 7,i7 ,to the extent the application seeks authorization to make modifications to the test within the scope of the approval1 a change protocol that includes validation procedures and acceptance criteria for anticipated modifications that could be made to the test within the scope of the approval4 7,j7 ,proposed labeling1 in accordance with the requirements of section #ehg,k4 7,k7 ,such other data or information as the ,secretary may require in accordance with the least burdensome requirements of subsection 7j74 7#c7 ,guidance for premarket and special premarket applications ,in accordance with section #e of the ,verifying ,accurate ,leading-edge ,,ivct ,development ,act of #bjbj1 the ,secretary shall issue draft guidance detailing the information to be provided in a premarket application and special premarket application under this section4 ,the ,secretary shall issue final guidance not later than #ij calendar days after the close of the comment period for such guidance4 7#d7 ,refuse to file a premarket or special premarket application ,if1 after receipt of an application under this section1 the ,secretary refuses to file such application1 the ,secretary shall provide to the developer1 within #fj calendar days of receipt of such application1 a description of the reason for such refusal1 and identify the information required1 if any1 to allow for the filing of the application4 7#e7 ,substantive review for deficient application ,if1 after receipt of an application under this section1 the ,secretary determines that any portion of such application is deficient1 the ,secretary shall provide to the applicant1 within #ge calendar days of receipt of such application1 a description of such deficiencies and identify the information required to correct such deficiencies4 7d7 ,special premarket review 7#a7 ,in general ,any person may file with the ,secretary an application for special premarket approval for-- 7,a7 an instrument2 7,b7 a specimen receptacle2 7,c7 an in vitro clinical test eligible for a technology certification order under section #ehg;,d2 or 7,d7 a first-of-a-kind test1 unless it is a high-risk test1 a direct-to-consumer test1 or cross-referenced test that does not have mitigating measures4 7#b7 ,application content ,an application under paragraph 7#a7 shall include-- 7,a7 the information required for applications submitted under subsection 7c77#b71 except that applications under paragraph 7#a7 need not include-- 7i7 quality requirement information2 or 7ii7 raw data unless explicitly requested by the ,secretary2 7,b7 in the case of a specimen receptacle1 safety information2 and 7,c7 data1 as applicable1 to support software validation1 electromagnetic compatibility1 and electrical safety1 and information demonstrating compliance with maintaining quality systems documentation4 7#c7 ,inspections ,with respect to an application under paragraph 7#a71 preapproval inspections authorized by an employee of the ,food and ,drug ,administration or a person accredited under section #ehg,p need not occur unless requested by the ,secretary4 7e7 ,instrument family ,when an in vitro clinical test has been approved1 or is otherwise legally marketed1 for use on a specific approved or legally marketed instrument within an instrument family1 a submission under this section shall not be required for that in vitro clinical test in order for it to be used on a new instrument within that instrument's family4 7f7 ,amendments to an application 7#a7 ,in general ,an applicant may amend an original or supplemental application under subsection 7c7 or 7d74 7#b7 ,required amendment or supplement ,an applicant shall amend or supplement an application submitted under subsection 7c7 or 7d7 if the applicant becomes aware of information that-- 7,a7 could reasonably affect an evaluation of whether the applicable standard has been met2 or 7,b7 could reasonably affect the statement of contraindications1 warnings1 precautions1 and adverse reactions in the proposed labeling4 7#c7 ,request for amendment or supplement ,the ,secretary may request that an applicant amend or supplement an application under subsection 7c7 or 7d7 with any information necessary for review under this section4 7g7 ,action on an application for premarket approval 7#a7 ,review 7,a7 ,disposition ,as promptly as possible1 but not later than #ij calendar days after an application under subsection 7c7 is accepted for submission 7unless the ,secretary determines that an extension is necessary to review one or more major amendments to the application71 or not later than #fj calendar days after an application under subsection 7d7 is accepted for submission1 the ,secretary1 after considering any applicable report and recommendations pursuant to advisory committees under section #ehg;,g1 or prior to the establishment of such advisory committees1 any recommendations by a classification panel under section #eac1 shall issue an order approving the application1 unless the ,secretary finds that the grounds for approval in paragraph 7#b7 are not met4 7,b7 ,reliance on proposed labeling ,in determining whether to approve or deny an application under paragraph 7#a71 the ,secretary shall rely on the intended use included in the proposed labeling1 provided that such labeling is not false or misleading based on a fair evaluation of all material facts4 7#b7 ,approval of an application 7,a7 ,in general ,the ,secretary shall approve an application submitted under subsection 7c7 with respect to an in vitro clinical test if the ,secretary finds that there is a reasonable assurance that the applicable standard is met1 and-- 7i7 except as provided under subsection 7d71 the applicant is in compliance with applicable quality requirements in section #ehg;,j or as otherwise specified in a condition of approval1 or maintains the documentation required to be in compliance with such requirements if the applicant is not required to submit such documentation as a part of the application under this section2 7ii7 the application does not contain a false statement of material fact2 7iii7 based on a fair evaluation of all material facts1 the proposed labeling is truthful and non-misleading and complies with the requirements of section #ehg,k2 7iv7 except as provided under subsection 7d71 the applicant permits1 if requested1 authorized employees of the ,food and ,drug ,administration and persons accredited under section #ehg,p an opportunity-- 7,i7 to inspect at a reasonable time and in a reasonable manner the facilities and all pertinent equipment1 finished and unfinished materials1 containers1 and labeling therein1 including all things 7including records1 files1 papers1 and controls7 bearing on whether an in vitro clinical test is adulterated1 misbranded1 or otherwise in violation of this ,act2 and 7,,ii7 to view and to copy and verify all records pertinent to the application and the in vitro clinical test2 7v7 the test conforms with any applicable performance standards under section #ehg,q and any applicable mitigating measures under section #ehg;,e2 and 7vi7 all nonclinical laboratory studies and clinical investigations involving human subjects that are described in the application were conducted in a manner that meets the requirements of this section4 7,b7 ,conditions of approval ,an order approving an application pursuant to this paragraph may require conditions of approval for the in vitro clinical test1 including conformance with performance standards under section #ehg,q and restrictions under section #ehg,n4 7,c7 ,first-of-a-kind test ,for a first-of-a-kind in vitro clinical test1 an order approving an application pursuant to this paragraph-- 7i7 may impose requirements for tests with the same indications for use1 including conformance with performance standards under section #ehg,q and mitigating measures under section #ehg;,e1 and comply with restrictions under section #ehg,n2 and 7ii7 shall indicate whether subsequent in vitro clinical tests with the same intended use may meet an exemption set forth in section #ehg;,a4 7,d7 ,publication ,the ,secretary shall publish each order approving an application pursuant to this paragraph on the public website of the ,food and ,drug ,administration and make publicly available a summary of the data used to grant the approval1 except to the extent the ,secretary determines that such order-- 7i7 contains commercially confidential or trade secret information2 or 7ii7 relates to national security or countermeasures is restricted from disclosure pursuant to statutory provisions other than this section4 7#c7 ,review of denials ,an applicant whose application submitted under subsection 7c7 or 7d7 has been denied approval may1 by petition filed not more than #fj calendar days after the date on which the applicant receives notice of such denial1 obtain review of the denial in accordance with section #ehg,o4 7h7 ,supplements to an application 7#a7 ,risk ,analysis ,prior to implementing any modification to an in vitro clinical test1 the holder of the application approved under subsection 7c7 or 7d7 for such test shall perform risk analyses in accordance with section #ehg;,j1 unless such modification is included in the change protocol submitted by the applicant and approved under this section or exempt under section #ehg;,a7l74 7#b7 ,supplement requirement 7,a7 ,in general ,except as provided in subparagraph 7,b71 or otherwise specified by the ,secretary1 the holder of the application approved under subsection 7g7 for an in vitro clinical test shall submit to the ,secretary and receive approval of a supplement before implementing a modification to the test1 unless such modification is exempt under section #ehg;,a7l74 7,b7 ,adjustments to change protocol ,a person may submit under this paragraph a supplemental application adjusting the change protocol of the test at any time after the initial filing of an application under subsection 7c7 or 7d74 7,c7 ,exceptions ,subject to subparagraphs 7,d7 and 7,e71 and so long as the holder of an approved application submitted under subsection 7c7 or 7d7 for an in vitro clinical test does not add a manufacturing site1 or change activities at an existing manufacturing site1 with respect to the test1 the holder may1 without prior approval of a supplement1 implement the following modifications to the test3 7i7 ,modifications included in and implemented in accordance with an approved change protocol under subsection 7c77#b77;,i74 7ii7 ,modifications that do not change-- 7,i7 the analytical or clinical validity of the test2 7,,ii7 the intended use of the test unless provided under an approved change protocol under subsection 7c77#b77;,i72 or 7,,iii7 the safety of the specimen receptacles4 7iii7 ,labeling changes to address a safety concern4 7iv7 ,modifications that are exempt under section #ehg;,a7l74 7,d7 ,reporting for change protocol modifications ,as a component of the report required under subsection 7k71 the holder of an application approved under subsection 7g7 for an in vitro clinical test shall-- 7i7 report any modification to the test described in clause 7i7 or 7ii7 of subparagraph 7,b7 in the next annual report for the test under subsection 7k7 following the date on which the test1 with such modification1 is introduced into interstate commerce2 and 7ii7 include in such report-- 7,i7 a description of the modification2 and 7,,ii7 as applicable1 a summary of the analytical validity and clinical validity of the test1 as modified1 and any changes to acceptance criteria4 7,e7 ,reporting for other category of exceptions ,the holder of the application approved under subsection 7c7 or 7d7 for an in vitro clinical test shall-- 7i7 report to the ,secretary any modification to the test described in clause 7iii7 of subparagraph 7,c7 not more than #fj days after the date on which the test1 with the modification1 is introduced into interstate commerce2 and 7ii7 include in the report-- 7,i7 a summary of the relevant change or changes2 7,,ii7 the rationale for implementing such change or changes2 and 7,,iii7 a description of how the change or changes were evaluated4 7,f7 ,request for supplement ,upon review of the information received under subparagraph 7,d7 and a finding that the relevant modification is inconsistent with the standard specified under subparagraph 7,c71 the ,secretary may require a supplement under subparagraph 7,a74 ,if the ,secretary determines that a supplement under subparagraph 7,a7 is required1 the ,secretary shall notify the applicant of such determination4 ,such notification shall include a justification for the submission of a supplement4 ,prior to the submission of a supplement under this subparagraph1 the applicant may request a meeting or written correspondence to gain agency feedback as to the necessity of such supplemental filing4 ,the ,secretary shall respond to such meeting request within #cj calendar days of receipt4 7#c7 ,contents of ,supplement ,unless otherwise specified by the ,secretary1 a supplement under this subsection shall include-- 7,a7 for modifications other than manufacturing site changes-- 7i7 a description of the modification2 7ii7 data to demonstrate that the applicable standard is met2 7iii7 acceptance criteria2 and 7iv7 any revised labeling2 and 7,b7 for manufacturing site changes-- 7i7 the matter listed in subparagraph 7,a72 and 7ii7 information regarding the methods used in1 or the facilities or controls used for1 the development of the test to demonstrate compliance with the applicable quality requirements under section #ehg;,j4 7#d7 ,additional ,data ,the ,secretary may require1 when necessary1 data to evaluate a modification to an in vitro clinical test that is in addition to the data otherwise required under the preceding paragraphs if the data request is in accordance with the least burdensome requirements under subsection 7j74 7#e7 ,conditions of ,approval ,in an order approving a supplement under this subsection1 the ,secretary may require conditions of approval for the in vitro clinical test1 including compliance with restrictions under section #ehg,n and conformance to performance standards under section #ehg,q4 7#f7 ,approval ,the ,secretary shall approve a supplement under this subsection if-- 7,a7 the data demonstrate that the modified in vitro clinical test meets the applicable standard2 and 7,b7 the holder of the application approved under subsection 7g7 for the test has demonstrated compliance with applicable quality and inspection requirements1 as applicable and appropriate4 7#g7 ,publication ,the ,secretary shall publish on the public website of the ,food and ,drug ,administration notice of any order approving a supplement under this subsection1 except that such publication shall exclude-- 7,a7 commercial confidential or trade secret information2 and 7,b7 any other information that the ,secretary determines to relate to national security or countermeasures or to be restricted from disclosure pursuant to another provision of law4 7#h7 ,review of ,denial ,an applicant whose supplement under this subsection has been denied approval may1 by petition filed on or before the #fjth calendar day after the date upon which the applicant receives notice of such denial1 obtain review of the denial in accordance with section #ehg,o4 7i7 ,withdrawal and temporary suspension of approval 7#a7 ,order withdrawing approval 7,a7 ,in general ,the ,secretary may1 within #aj calendar days of providing due notice and an opportunity for an informal hearing to the holder of an approved application for an in vitro clinical test under this section1 issue an order withdrawing approval of the application if the ,secretary finds that-- 7i7 the grounds for approval in subsection 7g7 are no longer met2 or 7ii7 there is a reasonable likelihood that the test would cause death or serious adverse health consequences1 including by causing the absence1 delay1 or discontinuation of life-saving or life sustaining medical treatment4 7,b7 ,content ,an order under subparagraph 7,a7 withdrawing approval of an application shall state each ground for withdrawal and shall notify the holder of such application #fj calendar days prior to issuing such order4 7,c7 ,publication ,the ,secretary shall publish any order under subparagraph 7,a7 on the public website of the ,food and ,drug ,administration1 except that such publication shall exclude-- 7i7 commercial confidential or trade secret information2 and 7ii7 any other information that the ,secretary determines to relate to national security or countermeasures or to be restricted from disclosure pursuant to another provision of law4 7#b7 ,order of temporary suspension ,if1 after providing due notice and an opportunity for an informal hearing to the holder of an approved application for an in vitro clinical test under this section1 the ,secretary determines there is a reasonable likelihood that the in vitro clinical test would cause death or serious adverse health consequences1 including by causing the absence1 delay1 or discontinuation of life-saving or life-sustaining medical treatment1 the ,secretary shall by order temporarily suspend the approval of the application4 ,if the ,secretary issues such an order1 the ,secretary shall proceed expeditiously under paragraph 7#a7 to withdraw approval of such application4 7j7 ,least burdensome requirements 7#a7 ,in general ,in carrying out this subchapter1 the ,secretary shall consider the least burdensome means necessary to provide a reasonable assurance of analytical and clinical validity1 or applicable standard1 and other regulatory requirements1 as determined by the ,secretary4 7#b7 ,necessary defined ,for purposes of paragraph 7#a7 and paragraph 7#c71 the term necessary means the minimum required information that would support a determination by the ,secretary that the application provides a reasonable assurance of analytical and clinical validity1 or other applicable standard or regulatory requirement1 as determined by the ,secretary4 7#c7 ,consideration of role of postmarket information ,for purposes of this subsection1 the ,secretary shall consider the role of postmarket information in determining the least burdensome appropriate means necessary to demonstrate that the applicable standard and other regulatory requirements have been met4 7k7 ,annual report 7#a7 ,in general ,unless the ,secretary specifies otherwise1 the holder of an approved application under this section shall submit an annual report each year at a time designated by the ,secretary in the approval order4 ,such report shall-- 7,a7 identify all modifications required to be reported that an approved application holder has made to any test that is covered by the approval order1 including any modification that requires a supplement under subsection 7h77#b72 and 7,b7 include any other information required by the ,secretary4 7#b7 ,exception ,the annual reporting requirement in paragraph 7#a7 shall not apply to in vitro clinical tests that are deemed to have a premarket approval based on a prior approval under section #eae7;c71 clearance under section #eaj7k71 or authorization under section #eac7;f74 7l7 ,service of orders ,orders of the ,secretary under this section with respect to applications under subsection 7c7 or 7d7 or supplements under subsection 7h7 shall be served-- 7#a7 in person by any officer or employee of the ,department of ,health and ,human ,services designated by the ,secretary2 or 7#b7 by mailing the order by registered mail or certified mail or electronic equivalent addressed to the applicant at the last known address in the records of the ,secretary4 #ehg;,c4 ,breakthrough in vitro clinical tests 7a7 ,in ,general ,the purpose of this section is to encourage the ,secretary and provide the ,secretary with sufficient authority to apply efficient and flexible approaches to expedite the development of1 and prioritize the review of1 in vitro clinical tests that represent breakthrough technologies4 7b7 ,establishment of program ,the ,secretary shall establish a program to expedite the development of1 and provide for the priority review of1 in vitro clinical tests4 7c7 ,eligibility ,the program developed under subsection 7b7 shall be available for any in vitro clinical test that-- 7#a7 provides or enables more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions compared to existing approved or precertified alternatives2 and 7#b7 is a test-- 7,a7 that represents a breakthrough technology2 7,b7 for which no approved or precertified alternative exists2 7,c7 that offers a clinically meaningful advantage over existing approved or precertified alternatives1 including the potential1 compared to existing approved or precertified alternatives1 to reduce or eliminate the need for hospitalization1 improve patient quality of life1 facilitate patients' ability to manage their own care 7such as through self-directed personal assistance71 or establish long-term clinical efficiencies2 or 7,d7 the availability of which is in the best interest of patients or public health4 7d7 ,designation 7#a7 ,request ,to receive breakthrough approval under this section1 an applicant may request that the ,secretary designate the in vitro clinical test for expedited development and priority review4 ,any such request for designation may be made at any time prior to the submission of an application under section #ehg;,b1 and shall include information demonstrating that the test is eligible for designation under subsection 7c74 7#b7 ,determination ,not later than #fj calendar days after the receipt of a request under paragraph 7#a71 the ,secretary shall determine whether the in vitro clinical test that is the subject of the request meets the criteria described in subsection 7c74 ,if the ,secretary determines that the test meets the criteria1 the ,secretary shall designate the test for expedited development and priority review4 7#c7 ,review ,review of a request under paragraph 7#a7 shall be undertaken by a team that is composed of experienced staff and senior managers of the ,food and ,drug ,administration4 7#d7 ,withdrawal 7,a7 ,in general ,the designation of an in vitro clinical test under this subsection is deemed to be withdrawn1 and such in vitro clinical test shall no longer be eligible for designation under this section1 if an application for approval under section #ehg;,b is denied4 ,such test would be eligible for designation upon a new request for such designation4 7,b7 ,exception ,the ,secretary may not withdraw a designation granted under this subsection based on the subsequent approval or technology certification of another test that-- 7i7 is designated under this section2 or 7ii7 was given priority review under section #eae;,b4 7e7 ,actions ,for purposes of expediting the development and review of in vitro clinical tests under this section1 the ,secretary may take the actions and additional actions set forth in section #eae;,b7e7 when reviewing such tests4 ,any reference or authorization in section #eae;,b7e7 with respect to a device shall be deemed a reference or authorization with respect to an in vitro clinical test for purposes of this section4 7f7 ,guidance 7#a7 ,in general ,not later than one year after the date of enactment of the ,verifying ,accurate ,leading-edge ,,ivct ,development ,act of #bjbj1 the ,secretary shall issue draft guidance on the implementation of this section4 ,such guidance shall-- 7,a7 set forth the process by which a person may seek a designation under subsection 7d72 7,b7 provide a template for request under subsection 7d72 7,c7 identify the criteria the ,secretary will use in evaluating a request for designation2 and 7,d7 identify the criteria and processes the ,secretary will use to assign a team of staff1 including team leaders1 to review in vitro clinical tests designated for expedited development and priority review1 including any training required for such personnel to ensure effective and efficient review4 7#b7 ,process ,prior to finalizing the guidance under paragraph 7#a71 the ,secretary shall seek public comment on the draft guidance4 ,the ,secretary shall issue final guidance one year after the close of the comment period for the draft guidance4 7g7 ,annual ,report ,unless otherwise specified by the ,secretary1 the requirements under section #ehg;,b7k7 apply to in vitro clinical tests designated under this section4 7h7 ,service of orders ,orders of the ,secretary under this section shall be served-- 7#a7 in person by any officer or employee of the ,department of ,health and ,human ,services designated by the ,secretary2 or 7#b7 by mailing the order by registered mail or certified mail or electronic equivalent addressed to the applicant at his last known address in the records of the ,secretary4 #ehg;,d4 ,technology certification 7a7 ,in general 7#a7 ,eligibility ,any eligible person may seek a technology certification in accordance with this section4 7#b7 ,exception ,an in vitro clinical test is exempt from premarket review under section #ehg;,b if the developer is eligible under this section and the in vitro clinical test-- 7,a7 is an eligible in vitro clinical test under subsection 7b77#b72 and 7,b7 falls within the scope of a technology certification order issued under this section1 and such order is in effect4 7b7 ,eligibility 7#a7 ,eligible person ,in this section1 the term eligible person means an in vitro clinical test developer unless1 at the time such person seeks or would seek technology certification order1 the person-- 7,a7 has been found to have committed a significant violation of section #cec of the ,public ,health ,service ,act1 unless-- 7i7 such violation occurred more than #e years prior to the date on which such technology certification order is or would be sought2 7ii7 such violation has been resolved2 or 7iii7 such violation is not pertinent to any in vitro clinical test within the scope of the technology certification order that such person seeks or would seek2 or 7,b7 such person fails to maintain required certifications under section #cec of the ,public ,health ,service ,act2 7,c7 has been found to have submitted information that-- 7i7 makes false or misleading statements about a technology certification order previously issued or an application approved under section #ehg;,b2 or 7ii7 violates any requirement of this subchapter related to technology certification under this section or approval under section #ehg;,b1 where such violation exposes persons to serious risk of illness1 injury1 or death4 7#b7 ,eligible in vitro clinical test ,an in vitro clinical test is eligible under subsection 7a77#b7 for exemption from premarket review under section #ehg;,b unless-- 7,a7 such test is-- 7i7 a component or part of an in vitro clinical test as described under section #bja7ss77#a77;,b77v72 7ii7 an instrument under section #bja7ss77#a77;,b77ii72 7iii7 a specimen receptacle under section #bja7ss77#a77;,b77iii72 or 7iv7 an in vitro clinical test1 including reagents used in such tests1 intended for use for testing donors1 donations1 and recipients of blood1 blood components1 human cells1 tissues1 cellular-based products1 or tissue-based products2 or 7,b7 unless otherwise permitted pursuant to section #ehg;,f1 such test is-- 7i7 a first-of-a-kind in vitro clinical test2 7ii7 a test system for home use2 7iii7 a high-risk in vitro clinical test2 7iv7 a cross-referenced in vitro clinical test2 or 7v7 a direct-to-consumer in vitro clinical test4 7c7 ,public meeting and input 7#a7 ,public docket ,not later than #cj days after the date of enactment of the ,verifying ,accurate ,leading-edge ,,ivct ,development ,act of #bjbj1 the ,secretary shall establish a public docket to receive comments concerning recommendations for implementation of this section1 including criteria and procedures for subsections 7e7 through 7j74 ,the public docket shall remain open for the duration of time that this section remains in effect4 7#b7 ,public meeting ,not later than #ahj days after the date of enactment of the ,verifying ,accurate ,leading-edge ,,ivct ,development ,act of #bjbj1 the ,secretary shall convene a public meeting to which stakeholders from organizations representing patients and consumers1 academia1 and the in vitro clinical test industry are invited in order to discuss components of the technology certification process including application requirements1 inspections1 alignment with third-party accreditors1 and the definition of technology under section #ehg7ag74 ,the public meeting shall be assigned a docket number by the ,commissioner of ,food and ,drugs and made available for the submission of public comments4 7d7 ,guidance ,in accordance with section #e of the ,verifying ,accurate ,leading-edge ,,ivct ,development ,act of #bjbj1 the ,secretary shall issue a draft guidance on technology review including describing criteria or procedures relating to technology review under this section1 which shall be subject to public comment for a minimum of #fj days from issuance prior to finalizing such guidance documents after considering the comments received4 ,the guidance shall include an outline of the application and recertification process1 opportunities to meet with officials of the ,food and ,drug ,administration1 plans to streamline inspections1 and a list of applicable technologies4 ,the guidance shall be updated as appropriate1 and not less frequently than each time the ,secretary identifies a unique technology4 7e7 ,application for technology certification 7#a7 ,in general ,a person seeking a technology certification order shall submit an application under this subsection1 which shall contain the information specified under paragraph 7#b74 7#b7 ,content of application ,an application for technology certification shall contain-- 7,a7 a statement identifying the scope of the proposed technology certification1 which shall be no broader than a single technology intended to be offered under the application2 7,b7 information showing that the person seeking a technology certification order is an eligible person under subsection 7b77#a72 7,c7 information showing that the methods used in1 and the facilities and controls used for1 the development of eligible in vitro clinical tests covered by the scope of the technology certification conform to the applicable quality requirements of section #ehg;,j2 7,d7 procedures for analytical validation1 including all procedures for validation1 verification1 and acceptance criteria1 and an explanation as to how such procedures1 when used1 provide a reasonable assurance of analytical validity of all eligible in vitro clinical tests within the proposed scope of technology certification order2 7,e7 information showing that the person has an established clinical program1 including procedures for clinical validation1 including all procedures for validation1 verification1 and acceptance criteria1 and an explanation as to how such procedures1 when used1 provide a reasonable assurance of clinical validity of all eligible in vitro clinical tests within the proposed scope of technology certification order2 7,f7 a notification under section #ehg;,i for each applicable in vitro clinical test that the developer plans to offer initially upon receiving a technology certification order and that would be introduced or delivered for introduction into interstate commerce upon the issuance of the technology certification order2 7,g7 information concerning one or more representative in vitro clinical tests1 including-- 7i7 one of the tests within the scope of the technology certification application with the greatest analytical complexity at the time of the filing of the application under this section that would be introduced or delivered for introduction into interstate commerce upon the issuance of the technology certification order to serve as the representative test and validate and run within the developer's stated scope1 and a rationale for such selection2 7ii7 the information specified in subsection 7c7 or 7d7 of section #ehg;,b for the representative in vitro clinical test or tests1 except that raw data shall be provided for any such in vitro clinical test unless the ,secretary determines otherwise2 7iii7 an explanation of the choice of the representative in vitro clinical test or tests for the technology certification application and how such test adequately demonstrates the range of procedures that the developer includes in the application under subparagraphs 7,c71 7,d71 7,e71 and 7,f72 and 7iv7 a brief explanation of the ways in which the procedures included in the application under subparagraphs 7,c71 7,d71 7,e71 and 7,f7 have been applied to the representative in vitro clinical test or tests2 7,h7 such other information relevant to the subject matter of the application as the ,secretary may require2 and 7,i7 a statement that the applicant believes to the best of the applicant's knowledge that all data and information submitted to the ,secretary are truthful and accurate and that no material fact has been omitted4 7f7 ,action on an application for technology certification 7#a7 ,secretary response 7,a7 ,in general ,as promptly as practicable1 and no later than #ij days after receipt of an application under subsection 7c71 the ,secretary shall-- 7i7 issue a technology certification order granting the application1 which shall specify the scope of the technology certification1 if the ,secretary finds that all of the grounds in paragraph 7#c7 are met2 or 7ii7 deny the application if the ,secretary finds 7and sets forth the basis of such finding as part of or accompanying such denial7 that one or more grounds for granting the application specified in paragraph 7#c7 are not met4 7,b7 ,extension ,the timeline described in subparagraph 7,a7 may be extended by mutual agreement between the ,secretary and the applicant4 7#b7 ,deficient applications ,if1 after receipt of an application under this section1 the ,secretary determines that any portion of such application is deficient1 the ,secretary1 not later than #ij days after receipt of such application1 shall provide to the applicant a description of such deficiencies and identify the information required to correct such deficiencies4 7#c7 ,approval ,the ,secretary shall grant a technology certification order under this section if1 on the basis of the information submitted to the ,secretary as part of the application and any other information with respect to such applicant1 the ,secretary finds that-- 7,a7 in accordance with subsection 7e77#b77;,d71 there is a showing of reasonable assurance of analytical validity for all eligible in vitro clinical tests within the proposed scope of the technology certification1 as evidenced by the procedures for analytical validation2 7,b7 in accordance with subsection 7e77#b77;,e71 there is a showing of reasonable assurance of clinical validity for all eligible in vitro clinical tests within the proposed scope of the technology certification1 as evidenced by the clinical program1 including procedures for clinical validation2 7,c7 the methods used in1 or the facilities or controls used for1 the development of eligible in vitro clinical tests covered by the proposed scope of the technology certification conform to the applicable requirements of section #ehg;,j2 7,d7 based on a fair evaluation of all material facts1 the applicant's proposed labeling and advertising is not false or misleading in any particular2 7,e7 the application does not contain a false statement of material fact2 7,f7 there is a showing that the representative in vitro clinical test or tests-- 7i7 meets the applicable standard for approval2 and 7ii7 reasonably represent the range of procedures for analytical validation and clinical validation included in the application1 as applicable2 and 7,g7 the applicant permits authorized employees of the ,food and ,drug ,administration or persons accredited under this ,act an opportunity to inspect at a reasonable time and in a reasonable manner the facilities and all pertinent equipment1 finished and unfinished materials1 containers1 and labeling therein1 including all things 7including records1 files1 papers1 and controls7 bearing on whether an in vitro clinical test is adulterated1 misbranded1 or otherwise in violation of this ,act1 and permits such authorized employees or persons accredited under this ,act to view and to copy and verify all records pertinent to the application and the in vitro clinical test4 7#d7 ,review of denials ,an applicant whose application has been denied may1 by petition filed on or before the date that is #cj calendar days after the date upon which such applicant receives notice of such denial1 obtain review thereof in accordance with section #ehg,o4 7g7 ,duration2 subsequent submissions 7#a7 ,order duration ,a technology certification order shall remain in effect until the earlier of-- 7,a7 the expiration of such technology certification order under paragraph 7#b72 or 7,b7 the withdrawal of such technology certification order under subsection 7j74 7#b7 ,expiration ,an initial technology certification order issued under subsection 7f77#c7 shall expire on such date specified by the ,secretary that is not later than #d years after the date that such order is issued1 except that if an application for renewal under paragraph 7#c7 has been received not later than #cj days prior to the expiration of such order under this paragraph1 such order shall expire on the date on which the ,secretary has granted or denied the application for renewal4 ,any such subsequent renewal of a technology certification shall expire on such date specified by the ,secretary that is not later than #d years after the date that such technology certification order is issued4 7#c7 ,renewal 7,a7 ,in general ,any person with a technology certification order in effect with respect to development of in vitro clinical tests may seek renewal of such order provided that-- 7i7 such person is an eligible person under subsection 7b77#a72 and 7ii7 none of the information specified in subsection 7e77#b7 has substantially changed1 except as described in supplements approved under paragraph 7#d74 7,b7 ,content ,an application for renewal under this paragraph shall include information concerning one or more representative in vitro clinical tests in accordance with subsection 7e77#b77;,g71 except that such representative test or tests shall be different from the representative test or tests relied upon as the representative assay in any prior technology certification that has not yet been reviewed1 if applicable4 7,c7 ,process ,the ,secretary's action on an application for renewal of technology certification under this paragraph shall be conducted1 to the extent practicable1 in coordination with inspections conducted under section #cec of the ,public ,health ,service ,act1 and any order resulting from such renewal application shall be treated as a technology certification order for purposes of this subchapter4 7#d7 ,supplements and reports 7,a7 ,supplements ,except as provided in subparagraph 7,b71 any person with a technology certification order in effect may seek a supplement to such order upon a change or changes to the information provided in the application for technology certification under subparagraphs 7,c71 7,d71 and 7,e7 of subsection 7e77#b71 provided that-- 7i7 such person is an eligible person under subsection 7b77#a72 and 7ii7 that such change does not expand the scope of the technology certification unless the ,secretary deems appropriate4 ,a supplement may contain only information relevant to the change or changes4 ,the ,secretary's action on a supplement shall be in accordance with subsection 7f71 and any order resulting from such supplement shall be treated as an amendment to a technology certification order that is in effect4 7,b7 ,reports 7i7 ,in general ,if a change described in subparagraph 7,a7 is made in order to address a potential risk to public health by adding a new specification or test method1 the person may immediately implement such change or changes and shall report such changes or changes to the ,secretary within #cj days4 7ii7 ,content ,any report to the ,secretary under this subparagraph shall include-- 7,i7 a summary of the relevant change or changes2 7,,ii7 the rationale for implementing such change or changes2 and 7,,iii7 a description of how the change or changes were evaluated4 7iii7 ,supplemental reports ,upon review of such report and a finding that the relevant change or changes are inconsistent with the standard specified under this subparagraph1 the ,secretary may require a supplement under subparagraph 7,a74 7h7 ,maintenance requirements ,for the duration of a technology certification order1 a holder of a technology certification order shall-- 7#a7 use the procedures included in the relevant application1 supplement1 or report under subsections 7b7 and 7e72 7#b7 ensure compliance with any applicable mitigating measures2 7#c7 maintain1 and provide to the ,secretary upon request1 records related to any in vitro clinical test offered without premarket review under the technology certification order1 where those records are necessary to demonstrate compliance with applicable provisions of this subchapter2 and 7#d7 comply with the notification requirements under section #ehg;,i for each in vitro clinical test offered without premarket review under the technology certification order4 7i7 ,temporary hold 7#a7 ,in general ,upon one or more findings under paragraph 7#d7 and after promptly notifying the developer of such findings1 the ,secretary may issue a temporary hold prohibiting any holder of a technology certification order from introducing into interstate commerce an in vitro clinical test that was not previously the subject of a notification under section #ehg;,i4 ,the temporary hold must identify the grounds for the temporary hold under paragraph 7#d7 and the rationale for such finding4 7#b7 ,notification to the developer ,the ,secretary shall not place a temporary hold under this subsection unless the ,secretary has promptly notified the developer of such hold and provided #cj calendar days for the developer to come into compliance with or resolve the findings under paragraph 7#d74 7#c7 ,written requests ,any written request to the ,secretary from the holder of a technology certification order that a temporary hold under paragraph 7#a7 be removed shall receive a decision1 in writing and specifying the reasons therefore1 within #ij days after receipt of such request4 ,any such request shall include information to support the removal of the temporary hold4 7#d7 ,grounds for temporary hold ,a temporary hold under this subsection may be instated upon a finding or findings that the holder of a technology certification order-- 7,a7 is not in compliance with any maintenance requirements under subsection 7h72 7,b7 labels or advertises one or more in vitro clinical tests with false or misleading claims2 or 7,c7 is no longer an eligible person under subsection 7b77#a74 7j7 ,withdrawal ,the ,secretary may1 after due notice and opportunity for informal hearing1 issue an order withdrawing a technology certification order if the ,secretary finds that-- 7#a7 the application1 supplement1 or report under subsection 7e7 or 7g7 contains false or misleading information or fails to reveal a material fact2 7#b7 such holder fails to correct false or misleading labeling or advertising upon the request of the ,secretary2 7#c7 in connection with a technology certification1 the holder provides false or misleading information to the ,secretary2 or 7#d7 the holder of such technology certification order fails to correct the grounds for temporary hold within a timeframe specified in the temporary hold order4 7k7 ,reports to ,congress 7#a7 ,in general ,not later than one year after the effective date1 and annually for #d years thereafter1 the ,secretary shall prepare and submit to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate1 and make publicly available1 including through posting on the internet website of the ,food and ,drug ,administration1 a report containing the information required under paragraph 7#b74 7#b7 ,content 7,a7 ,in general ,each report under paragraph 7#a7 shall address1 at a minimum-- 7i7 the total number and type of applications for technology certifications filed1 granted1 withdrawn or denied2 7ii7 the total number of technology certification orders put on temporary hold under subsection 7i7 and the number of technology certification orders withdrawn under subsection 7j72 7iii7 the types of technologies for which technology certification orders were granted2 and 7iv7 the total number of laboratories and developers with technology certification orders in effect4 7,b7 ,final report ,the fifth report submitted under paragraph 7#a7 shall include a summary of1 and responses to1 comments raised in the meeting and docket4 7,c7 ,performance reports ,the reports required under this section may be issued as a component of performance reports as required under section #i of the ,verifying ,accurate ,leading-edge ,,ivct ,development ,act of #bjbj4 #ehg;,e4 ,mitigating measures 7a7 ,establishment of mitigating measures 7#a7 ,establishing1 changing1 or withdrawing 7,a7 ,establishment ,if the ,secretary determines that the establishment of mitigating measures is necessary for either of the reasons described in clause 7i7 or 7ii7 of section #ehg7ae77;,a7 for any in vitro clinical test with the same indications for use1 the ,secretary may require that the in vitro clinical test comply with such mitigating measures4 7,b7 ,process ,notwithstanding subchapter ,,ii of chapter #e of title #e1 ,united ,states ,code1 the ,secretary may-- 7i7 establish1 change1 or withdraw mitigating measures by-- 7,i7 publishing a proposed administrative order in the ,federal ,register2 7,,ii7 providing an opportunity for public comment for a period of not less than #cj calendar days2 and 7,,iii7 after consideration of any comments submitted1 publishing a final administrative order in the ,federal ,register2 and 7ii7 may establish mitigating measures with respect to a category in a premarket approval order or technology certification order4 7#b7 ,in vitro clinical tests previously approved1 cleared1 or exempted as devices 7,a7 ,in general ,any special controls or restrictions applicable to an in vitro clinical test with the same indications for use pursuant to section #ehg7aj7 based on prior regulation as a device approved under section #eae1 cleared or exempt under section #eaj7k71 or classified under section #eac7;f77#b71 including any such special controls or restrictions established during the period beginning on the date of enactment of the ,verifying ,accurate ,leading-edge ,,ivct ,development ,act of #bjbj and ending on the effective date of such ,act 7as described in section #e7;b7 of such ,act7-- 7i7 shall continue to apply to such approved1 cleared1 or exempted in vitro clinical test after such effective date2 and 7ii7 are deemed to be mitigating measures as of the effective date of such approval1 clearance1 or exemption4 7,b7 ,changes ,the ,secretary may establish1 change1 or withdraw mitigating measures for such a test or indications for use the procedures under paragraph 7#a74 7b7 ,documentation 7#a7 ,tests subject to premarket review ,the developer of an in vitro clinical test subject to premarket review under section #ehg;,b and to which mitigating measures apply shall-- 7,a7 in accordance with section #ehg;,b7c77#b77;,g77i71 submit documentation to the ,secretary as part of the application for the test under subsection 7c7 or 7d7 of section #ehg;,b demonstrating that such mitigating measures have been met2 7,b7 if such application is approved1 maintain documentation demonstrating that such mitigating measures continue to be met following a test modification by the developer2 and 7,c7 after responding to any informal communications from the ,secretary1 make such documentation available to the ,secretary upon request or inspection4 7#b7 ,other tests ,the developer of an in vitro clinical test that is marketed within the scope of a technology certification order or other exemption from premarket review under section #ehg;,b and to which mitigating measures apply shall-- 7,a7 maintain documentation in accordance with the applicable quality requirements under section #ehg;,j demonstrating that such mitigating measures continue to be met following a test modification by the developer2 7,b7 after responding to any informal communications from the ,secretary1 make such documentation available to the ,secretary upon request or inspection2 and 7,c7 include in the performance summary for such test a brief description of how such mitigating measures are met1 if applicable4 7c7 ,mitigating measures for cross-,referenced tests ,not later than #a year after the implementation of the ,verifying ,accurate ,leading-edge ,,ivct ,development ,act of #bjbj1 the ,secretary shall issue mitigating measures for cross-referenced tests4 #ehg;,f4 ,regulatory pathway redesignation 7a7 ,technology certification and exemption determinations 7#a7 ,in general ,based on new information1 including the establishment of mitigating measures under section #ehg;,e1 and after considering available evidence respecting tests with the same indications for use pursuant to section #ehg7aj71 the ,secretary may1 upon the initiative of the ,secretary or upon petition of an interested person-- 7,a7 revoke any exemption or requirement in effect under this subchapter with respect to such indications for use2 or 7,b7 determine that such indications for use are eligible for technology certification in accordance with section #ehg;,d7b77#b71 or are otherwise exempt from premarket review under section #ehg;,b4 7#b7 ,process ,any action under paragraph 7#a7 shall be made by publication of a notice of such proposed action on the internet website of the ,food and ,drug ,administration1 the consideration of comments to a public docket on such proposal1 and publication of a final action on such internet website within #fj calendar days of the close of the comment period posted to such public docket1 notwithstanding subchapter ,,ii of chapter #e of title #e1 ,united ,states ,code4 7b7 ,revocation ,the ,secretary may revoke any exemption with respect to such test or indications for use pursuant to section #ehg7aj71 if-- 7#a7 new clinical information indicates that the exemption of an in vitro clinical test or tests from premarket review under section #ehg;,b or exemption under section #ehg;,a has a reasonable probability of severe adverse health consequences1 including the absence1 delay1 or discontinuation of appropriate medical treatment4 7#b7 ,process ,any action under this subsection shall be made by publication of a notice of such proposed action in the ,federal ,register1 consideration of comments to a public docket on such proposal1 and publication of a final notice in the ,federal ,register1 notwithstanding subchapter ,,ii of chapter #e of title #e1 ,united ,states ,code4 #ehg;,g4 ,advisory committees 7a7 ,in general ,the ,secretary may establish advisory committees or use advisory committee panels of experts established before the date of enactment of this section for the purposes of providing expert scientific advice and making recommendations related to-- 7#a7 the approval of an application for an in vitro clinical test submitted under this subchapter1 including for evaluating1 as applicable1 the analytical validity1 clinical validity1 and safety of in vitro clinical tests2 7#b7 the potential effectiveness of mitigating measures for a determination on the applicable regulatory pathway under section #ehg;,f or risk evaluation for an in vitro clinical test or tests2 7#c7 quality requirements under section #ehg;,j or applying such requirements to in vitro clinical tests developed or imported by developers2 or 7#d7 such other purposes as the ,secretary determines appropriate4 7b7 ,appointments 7#a7 ,voting members ,the ,secretary shall appoint to each committee established under subsection 7a71 as voting members1 individuals who are qualified by training and experience to evaluate in vitro clinical tests referred to the committee for the purposes specified in subsection 7a71 including individuals with1 to the extent feasible1 scientific expertise in the development1 manufacture1 or utilization of such in vitro clinical tests1 laboratory operations1 and the use of in vitro clinical tests4 ,the ,secretary shall designate one member of each committee to serve as chair4 7#b7 ,nonvoting members ,in addition to the individuals appointed pursuant to paragraph 7#a71 the ,secretary shall appoint to each committee established under subsection 7a71 as nonvoting members-- 7,a7 a representative of consumer interests2 and 7,b7 a representative of interests of in vitro clinical test developers not directly affected by the matter to be brought before the committee4 7#c7 ,limitation ,no individual who is in the regular full-time employee of the ,united ,states and engaged in the administration of this ,act may be a member of any advisory committee established under subsection 7a74 7#d7 ,education and training ,the ,secretary shall1 as appropriate1 provide education and training to each new committee member before such member participates in a committee's activities1 including education regarding requirements under this ,act and related regulations of the ,secretary1 and the administrative processes and procedures related to committee meetings4 7#e7 ,meetings ,the ,secretary shall ensure that scientific advisory committees meet regularly and at appropriate intervals so that any matter to be reviewed by such a committee can be presented to the committee not more than #fj calendar days after the matter is ready for such review4 ,meetings of the committee may be held using electronic communication to convene the meetings4 7#f7 ,compensation ,members of an advisory committee established under subsection 7a71 while attending meetings or conferences or otherwise engaged in the business of the advisory committee-- 7,a7 shall be entitled to receive compensation at rates to be fixed by the ,secretary1 but not to exceed the daily equivalent of the rate in effect for positions classified above level ,,gs-#ae of the ,general ,schedule2 and 7,b7 may be allowed travel expenses as authorized by section #egjc of title #e1 ,united ,states ,code1 for employees serving intermittently in the ,government service4 7c7 ,guidance ,the ,secretary may issue guidance on the policies and procedures governing advisory committees established under subsection 7a74 #ehg;,h4 ,request for informal feedback ,before submitting a premarket application or technology certification application for an in vitro clinical test-- 7#a7 the developer of the test may submit to the ,secretary a written request for a meeting or conference to discuss and provide information relating to the regulation of such in vitro clinical test which may include-- 7,a7 the submission process and the type and amount of evidence expected to demonstrate the applicable standard2 7,b7 which regulatory pathway is appropriate for an in vitro clinical test2 and 7,c7 an investigation plan for an in vitro clinical test1 including a clinical protocol2 and 7#b7 upon receipt of such a request1 the ,secretary shall-- 7,a7 within #fj calendar days after such receipt1 or within such time period as may be agreed to by the developer1 meet or confer with the developer submitting the request2 and 7,b7 within #ae calendar days after such meeting or conference1 provide to the developer a written record or response describing the issues discussed and conclusions reached in the meeting or conference4 #ehg;,i4 ,registration and listing 7a7 ,registration of ,establishments for ,in ,vitro ,clinical ,tests 7#a7 ,in general ,each person described in subsection 7b77#a71 or an accredited person under section #ehg,p1 acting on behalf of such a person1 shall-- 7,a7 during the period beginning on ,october #a and ending on ,december #ca of each year1 register with the ,secretary the name of such person1 places of business of such person1 all establishments engaged in the activities specified under this paragraph1 the establishment registration number of each such establishment1 and a point of contact for each such establishment1 including an electronic point of contact2 and 7,b7 submit an initial registration containing the information required under subparagraph 7,a7 not later than-- 7i7 the date of implementation of this section if such establishment is engaged in any activity described in subsection 7b77#a7 on the date of enactment of this section1 unless the ,secretary establishes by guidance a date later than such implementation date for all or a category of such establishments2 or 7ii7 #cj days prior to engaging in any activity described in subsection 7b77#a7 after enactment of this section1 if such establishment is not engaged in any activity described in this paragraph on the date of enactment of this section4 7#b7 ,registration numbers ,the ,secretary may assign a registration number to any person or an establishment registration number to any establishment registered in accordance with this section4 ,registration information shall be made publicly available by publication on the internet website maintained by the ,food and ,drug ,administration1 in accordance with subsection 7d74 7#c7 ,inspection ,every person or establishment that is required to be registered with the ,secretary under this section shall be subject to inspection pursuant to section #gjd4 7b7 ,listing ,information for ,in ,vitro ,clinical ,tests 7#a7 ,in general ,each person who-- 7,a7 is a developer1 a contract manufacturer 7including contract packaging71 contract sterilizer1 repackager1 relabeler1 or distributor of an in vitro clinical test2 and 7,b7 introduces or proposes to begin the introduction or delivery for introduction into interstate commerce through an exemption under section #ehg;,a7f77#b77;b7 or #ehg;,a7g7 or through the filing of an application under section #ehg;,b or #ehg;,d1 shall submit a listing to the ,secretary containing the information described in paragraph 7#b7 in accordance with the applicable schedule described under subsection 7c74 ,such listing shall be prepared in such form and manner as the ,secretary may specify in guidance4 ,listing information shall be submitted through the comprehensive test information system in accordance with section #ehg,t1 as appropriate4 7#b7 ,submissions ,each developer submitting a listing under paragraph 7#a7 shall electronically submit to the comprehensive test information system under section #ehg,t the following information for each in vitro clinical test for which such person is a developer in the form and manner prescribed by the ,secretary3 7,a7 ,name of the establishment and its facility registration number4 7,b7 ,contact information for the official correspondent for the listing4 7,c7 ,name 7common name and trade name1 if applicable7 of the in vitro clinical test and its test listing number 7when available74 7,d7 ,,clia certificate number for any laboratory certified by the ,secretary under section #bfc;a of title #db that meets the requirements for performing high-complexity testing that is the developer of the in vitro clinical test1 and ,,clia certificate number for any laboratory under common ownership that is performing the test developed by such test developer4 7,e7 ,whether the in vitro clinical test is1 as applicable1 offered as a test approved under section #ehg;,b1 offered under a technology certification order issued under section #ehg;,d1 or offered as an in vitro clinical test under section #ehg;,a4 7,f7 ,indications for use information under section #ehg7aj74 7,g7 ,brief narrative description of the in vitro clinical test4 7,h7 ,a brief summary of the analytical and clinical performance of the in vitro clinical test1 and as applicable1 the lot release criteria4 7,i7 ,a brief description of conformance with any applicable mitigating measures1 restrictions1 and standards4 7,j7 ,representative labeling for the in vitro clinical test1 as appropriate4 7,k7 ,a statement that the information submitted is truthful and accurate4 7#c7 ,test listing number ,the ,secretary may assign a test listing number to each in vitro clinical test that is the subject of a listing under this section4 ,the process for assigning test listing numbers may be established through guidance1 and may include the recognition of standards1 formats1 or conventions developed by a third-party organization4 7#d7 ,abbreviated listing ,a person who is not a developer but is otherwise required to register pursuant to subsection 7a7 shall submit an abbreviated listing to the ,secretary containing the information described in subparagraphs 7,a7 through 7,c7 of paragraph 7#b71 and the name of the developer4 ,the information shall be submitted in accordance with the applicable schedule described under subsection 7c74 ,such abbreviated listing shall be prepared in such form and manner as the ,secretary may specify in guidance4 ,listing information shall be submitted to the comprehensive test information system in accordance with section #ehg,t1 as appropriate4 7#e7 ,grandfathered tests ,a developer of an in vitro clinical test developer offering a test that is grandfathered under section #ehg;,a7c7 shall submit listing information required under subparagraphs 7,a7 through 7,i7 of paragraph 7#b74 7#f7 ,low-risk tests ,a developer of a low risk in vitro clinical test shall notify and submit listing information to the ,secretary within one year of offering such test for clinical use4 7#g7 ,exempt tests ,a developer of an in vitro clinical test who introduces or proposes to begin the introduction or delivery for introduction into interstate commerce pursuant to an exemption under section #ehg;,a may submit listing information under this subsection4 7c7 ,timelines for ,submission 7#a7 ,in general ,the timelines for submission of registration and listing under subsections 7a7 and 7b7 are as follows3 7,a7 ,for an in vitro clinical test that was listed as a device under section #eaj7;j7 prior to the date of enactment of this section1 a person shall maintain a device listing under section #eaj until such time as the system for submitting the notification information required under subsection 7b7 becomes available and thereafter shall submit the notification information no later than #a year after the system for submitting the notification under this section becomes available4 7,b7 ,for an in vitro clinical test that is subject to the grandfathering provisions of section #ehg;,a7c71 a person shall submit the listing information required under subsection 7b77#e7 no later than #a year after the system for submitting the notification under this section becomes available4 7,c7 ,for an in vitro clinical test that is not subject to subparagraph 7,a7 or 7,b71 a person shall submit the required notification information prior to offering1 introducing1 or marketing the in vitro clinical test as follows3 7i7 ,for an in vitro clinical test that is not exempt from premarket approval under section #ehg;,b1 a person shall submit the required listing information no later than #cj business days after the date of approval of the premarket approval application4 7ii7 ,for a developer who has received a technology certification order under section #ehg;,d1 a person shall submit the required listing information at least #cj business days after receiving such technology certification order4 7#b7 ,updates 7,a7 ,updates after changes ,each developer required to submit listing information under this section shall update such information within #aj business days of any change that causes any previously notified information to be inaccurate or incomplete4 7,b7 ,annual updates ,each developer required to submit listing information under this section shall update its information annually during the period beginning on ,october #a and ending on ,december #ca of each year as a component of the annual report submitted under sections #ehg;,b and #ehg;,d4 7d7 ,public ,availability of ,notification ,information 7#a7 ,in general ,notification information submitted pursuant to this section shall be made publicly available on the website of the ,food and ,drug ,administration in accordance with paragraph 7#c74 7#b7 ,confidentiality ,notification information for an in vitro clinical test that is subject to premarket approval or technical certification shall remain confidential until such date as the in vitro clinical test receives the applicable premarket approval or the developer receives a technology certification order4 7#c7 ,exceptions from public availability requirements ,the registration and listing information requirements described in subsections 7a7 and 7b7 shall not apply to the extent the ,secretary determines that such information relates to-- 7,a7 trade secret or commercial confidential information2 or 7,b7 national security or countermeasures or is restricted from disclosure pursuant to another provision of law4 7e7 ,submission of information by accredited persons ,if agreed upon by the developer1 the information required under this section may be submitted by an accredited person under section #ehg,p4 #ehg;,j4 ,test design and quality requirements 7a7 ,applicability 7#a7 ,in general ,each developer and each other person required to register under section #ehg;,i7b77#a7 shall establish and maintain quality requirements in accordance with the applicable requirements set forth in subsection 7b71 except as provided in section #ehg;,a4 7#b7 ,certified laboratory requirements ,a developer that operates a clinical laboratory certified by the ,secretary under section #cec of the ,public ,health ,service ,act that-- 7,a7 meets the requirements for performing high-complexity testing2 7,b7 7i7 develops an vitro clinical test or indications for use2 or 7ii7 modifies another developer's in vitro clinical test in that certified laboratory in a manner described in section #ehg7f72 and 7,c7 develops an in vitro clinical test or indications for use that are for use only within that certified laboratory or within another certified laboratory with common ownership1 shall establish and maintain quality requirements that comply with the requirements set forth in subsection 7b77#b74 7#c7 ,applicability for certain in vitro clinical tests ,the applicable requirements set forth in subsection 7b77#a7 shall apply to any instrument1 specimen receptacle1 or component or part that is developed for use by a clinical laboratory to which paragraph 7#b7 applies4 7#d7 ,regulations ,the ,secretary may promulgate regulations to implement this section4 ,in so promulgating regulations1 the ,secretary shall consider whether and to what extent international harmonization is appropriate4 7b7 ,quality requirements 7#a7 ,quality requirements for laboratories without ,,clia certification to conduct high-complexity tests ,the quality requirements applicable under this section shall-- 7,a7 avoid duplication of regulations under section #cec of the ,public ,health ,service ,act2 7,b7 apply only to the development1 validation1 production1 preparation1 propagation1 or assembly related to the design and associated manufacture and distribution of an in vitro clinical test offered under this subchapter2 7,c7 not apply with respect to laboratory operations2 and 7,d7 shall include the following1 subject to paragraphs 7#b7 and 7#c7-- 7i7 management responsibility2 7ii7 quality audits2 7iii7 personnel2 7iv7 design controls2 7v7 document controls2 7vi7 purchasing controls2 7vii7 identification and traceability2 7viii7 production and process controls2 7ix7 acceptance activities2 7x7 nonconforming product2 7xi7 corrective and preventive action2 7xii7 labeling and packaging controls2 7xiii7 handling1 storage1 distribution1 and installation2 7xiv7 records2 7xv7 servicing2 and 7xvi7 statistical techniques4 7#b7 ,quality requirements for laboratories certified to conduct high-complexity tests ,quality requirements applicable to the in vitro clinical tests and developers described in subsection 7a77#b7 shall-- 7,a7 avoid duplication of regulations under section #cec of the ,public ,health ,service ,act2 and 7,b7 consist of1 as directed related to the design and development-- 7i7 design controls2 7ii7 purchasing controls2 7iii7 acceptance activities2 7iv7 corrective and preventative action2 and 7v7 records4 7#c7 ,quality requirements for certain laboratories distributing in vitro clinical tests or test protocols within organizations or public health networks 7,a7 ,in general ,quality requirements applicable to the developer who is distributing in vitro clinical test distributed as described in subparagraph 7,b7 shall consist of the following3 7i7 ,the requirements in paragraph 7#b74 7ii7 ,the labeling requirements in paragraph 7#a77;,c77xii74 7iii7 ,the requirement to maintain records of the laboratories to which the in vitro clinical test or test protocol is distributed4 7,b7 ,distributing laboratory ,subparagraph 7,a7 shall apply to developers that meet the following conditions3 7i7 ,the laboratory distributing the test protocol is certified by the ,secretary under section #cec of the ,public ,health ,service ,act and meets the requirements for performing high-complexity testing4 7ii7 ,the laboratory develops its own in vitro clinical test or modifies another developer's in vitro clinical test in a manner described in section #ehg7f74 7iii7 ,the laboratory distributes the in vitro clinical test or test protocol for such test only to another laboratory that-- 7,i7 is certified by the ,secretary under section #cec of the ,public ,health ,service ,act and meets the requirements for performing high-complexity testing2 7,,ii7 is within the same corporate organization and having common ownership by the same parent corporation2 or as applicable1 is a laboratory within a public health laboratory network coordinated or managed by the ,centers for ,disease ,control and ,prevention2 and 7,,iii7 implements the test protocol without further modification4 7c7 ,regulations ,in implementing quality requirements for test developers under this section1 the ,secretary shall-- 7#a7 for purposes of facilitating international harmonization1 consider whether the developer participates in an audit program in which the ,united ,states participates or the ,united ,states recognizes or conforms with standards recognized by the ,secretary2 and 7#b7 ensure a least burdensome approach described in section #ehg;,b7j7 by leveraging1 to the extent applicable1 the quality assurance requirements applicable to developers certified by the ,secretary under section #cec of the ,public ,health ,service ,act4 #ehg,k4 ,labeling requirements 7a7 ,in ,general ,an in vitro clinical test shall bear or be accompanied by labeling1 and a label as applicable1 that meet the requirements set forth in subsections 7b7 and 7c71 unless such test is exempt as specified in subsection 7d7 or 7e74 7b7 ,labels 7#a7 ,in general ,the label of an in vitro clinical test shall meet the requirements set forth in paragraph 7#b71 except this requirement shall not apply to an in vitro clinical test that-- 7,a7 consists solely of a test protocol2 or 7,b7 is developed1 manufactured1 and used solely within a single laboratory certified by the ,secretary under section #cec of the ,public ,health ,service ,act that meets the requirements for performing high-complexity testing4 7#b7 ,regulations ,the label of an in vitro clinical test shall state the name and place of business of its developer and meet the requirements set forth in regulations promulgated under this section4 7c7 ,labeling 7#a7 ,in general ,labeling accompanying an in vitro clinical test1 including labeling in the form of a package insert1 standalone laboratory reference document1 or other similar document except the labeling specified in paragraph 7#b71 shall include adequate directions for use and shall meet the requirements set forth in regulations promulgated under this section1 except as provided in subsection 7d7 or 7e74 ,labeling in the form of a package insert shall also include the information in subparagraph 7,a7 or 7,b7 of paragraph 7#b74 7#b7 ,content 7,a7 ,in general ,labeling accompanying an in vitro clinical test that is in the form of a test report template or ordering information shall include-- 7i7 the test listing number that was provided to the developer at the time of listing2 7ii7 instructions for how and where to report an adverse event under section #ehg,l2 7iii7 instructions for how and where to access the performance summary data displayed in the listing database for the test2 7iv7 the intended use of the in vitro clinical test2 and 7v7 any warnings1 contraindications1 or limitations4 7,b7 ,public availability of information ,the ,secretary shall make all of the information described in subparagraph 7,a7 with respect to each in vitro clinical test available to the public1 as applicable1 in accordance with section #ehg,t1 except to the extent that the ,secretary determines that such information is-- 7i7 trade secret or commercial confidential information2 or 7ii7 national security or countermeasures or is restricted from disclosure pursuant to another provision of law4 7#c7 ,additional requirements ,labeling for an in vitro clinical test used for immunohematology testing shall meet the following applicable requirements set forth in part #ffj of the ,code of ,federal ,regulations 7or any successor regulation71 related to the labeling of blood grouping reagents1 reagent red blood cells1 and anti-human globulin4 7d7 ,exemptions and alternative requirements 7#a7 ,in general 7,a7 ,in general ,with respect to an in vitro clinical test that meets the criteria of subparagraph 7,b71 the state in one place regulations under section #hji4aj7;b7 of title #ba of the ,code of ,federal ,regulations 7or any successor regulations7 may be satisfied by the laboratory posting such information on its website or in multiple documents1 if such documents are maintained and accessible in one place4 7,b7 ,applicable tests ,an in vitro clinical test meets the criteria of this subparagraph if such test is-- 7i7 designed and manufactured by a laboratory certified by the ,secretary under section #cec of the ,public ,health ,service ,act that meets the requirements for performing high-complexity testing2 and 7ii7 performed in the same laboratory in which it was developed or by another such laboratory certified by the ,secretary under section #cec of the ,public ,health ,service ,act that meets the requirements for performing high complexity testing and is under common ownership with the laboratory that designed and manufactured the test4 7#b7 ,test instrument labeling ,the labeling for an instrument is not required to bear the information indicated in paragraphs 7#c71 7#d71 7#e71 7#g71 7#h71 7#i71 7#aj71 7#aa71 7#ab71 and 7#ac7 of section #hji4aj7;b7 of title #ba of the ,code of ,federal ,regulations1 as it appears on the date of enactment of this subchapter and amended thereafter4 7#c7 ,reagent labeling ,for purposes of compliance with subsection 7c77#a71 the labeling for a reagent intended for use as a replacement in an in vitro clinical test may be limited to that information necessary to identify the reagent adequately and to describe its proper use in the system4 7#d7 ,lab ,research or ,investigational ,use ,a shipment or other delivery of an in vitro clinical test for research or investigational use pursuant to section #ehg;,a7m7 shall be exempt from the labeling requirements of subsections 7b7 and 7c77#a7 and from any standard promulgated through regulations1 except as required under section #cec of the ,public ,health ,service ,act or section #ehg,r of this ,act4 7#e7 ,general ,purpose ,laboratory ,reagents ,the labeling of general purpose laboratory reagents 7such as hydrochloric acid7 whose uses are generally known by persons trained in their use need not bear the directions for use required by subsection 7b7 and subsection 7c77#a74 7#f7 ,analyte ,specific ,reagents ,the labeling for analyte specific reagents shall bear the following statement3 ,this product is intended solely for further development of an in vitro clinical test and is exempt from most ,,fda regulation4 ,this product must be evaluated by the in vitro clinical test developer in accordance with applicable requirements44 ,if the labeling of an analyte specific reagent bears the information set forth in this paragraph1 it need not bear the information required by subsection 7c77#a74 7#g7 ,over-the-counter test sample collection systems labeling ,the labeling for over-the-counter test sample collection systems for drugs of abuse testing shall bear the name and place of business of the developer included in the registration listing under section #ehg;,i1 in language appropriate for the intended users4 ,if the labeling of such over-the-counter test sample collection system bears the information set forth in this paragraph 7#d77;,g71 it need not bear the information required by subsection 7c77#a74 7e7 ,tests in the ,strategic ,national ,stockpile 7#a7 ,in general ,the ,secretary may grant an exception or alternative to any provision listed in this section1 unless explicitly required by a statutory provision outside this section1 for specified lots1 batches1 or other units of an in vitro clinical test1 if the ,secretary determines that compliance with such labeling requirement could adversely affect the safety1 effectiveness1 or availability of such products that are or will be included in the ,strategic ,national ,stockpile4 7#b7 ,regulations ,the ,secretary may issue regulations amending section #hji4aa of title #ba of the ,code of ,federal ,regulations or any successor regulation to apply in full or in part to in vitro clinical tests and in vitro clinical test developers4 7f7 ,guidance ,the ,secretary may1 in collaboration with developers1 issue guidance on standardized1 general content and format for in vitro clinical test labeling to help ensure compliance with applicable requirements in this subsection4 #ehg,l4 ,adverse event reporting 7a7 ,applicability 7#a7 ,in general ,each in vitro clinical test developer shall establish and maintain a system for reporting adverse events in accordance with subsection 7b71 except as provided in section #ehg;,a4 7#b7 ,regulations ,the ,secretary shall promulgate regulations to implement this section1 including information necessary to be reported to ensure the analytical and clinical validity of in vitro clinical tests1 and the safety of articles for taking or deriving specimens from the human body4 7b7 ,adverse ,event ,reporting ,requirements ,each developer shall report to the ,secretary whenever information that reasonably suggests that one of the developer's in vitro clinical tests is associated with an adverse event becomes known to the developer4 7c7 ,reports ,reports required under this section shall be submitted as follows3 7#a7 ,an individual adverse event report shall be submitted for the following events not later than-- 7,a7 #e calendar days after an in vitro clinical test developer receives or otherwise becomes aware of information that reasonably suggests the adverse event involves a patient death2 or 7,b7 #e calendar days after an in vitro clinical test developer receives or otherwise becomes aware of information that reasonably suggests the event presents an imminent threat to public health4 7#b7 ,quarterly reports shall be submitted for all other adverse events1 if any1 and no later than the end of the quarter following the quarter in which the adverse event information was received by the in vitro clinical test developer4 7d7 ,definitions ,in this section-- 7#a7 the term adverse event-- 7,a7 means-- 7i7 death of1 or serious injury to1 a specific patient or user for which it is reasonably believed that an in vitro clinical test error contributed to such death or serious injury2 or 7ii7 an in vitro clinical test error that may have reasonable likelihood to cause serious injury or death2 and 7,b7 excludes laboratory errors that are subject to the requirements of section #cec of the ,public ,health ,service ,act and corrective or preventive actions to prevent such errors2 7#b7 the term in vitro clinical test error-- 7,a7 means a failure in an in vitro clinical test to meet the analytical or clinical validity standard or otherwise perform as intended by the developer2 and 7,b7 includes an inaccurate false result that reaches a health care provider1 patient1 or consumer1 except that such term excludes any such event or error related to laboratory operations pursuant to section #cec of the ,public ,health ,service ,act2 and 7#c7 the term serious injury means-- 7,a7 a significant delay in a critical diagnosis or causing the absence1 delay1 or discontinuation of critical medical treatment or that irreversibly or seriously and negatively alters the course of the disease or condition2 or 7,b7 an injury that-- 7i7 is life threatening2 7ii7 results in permanent impairment of a body function or permanent damage to a body structure2 or 7iii7 necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure4 #ehg,m4 ,corrections and removals 7a7 ,in general ,the ,secretary shall promulgate regulations to implement this section1 including information necessary to be reported to ensure the analytical and clinical validity of in vitro clinical tests1 and the safety of specimen receptacles4 7b7 ,reports of removals and corrections 7#a7 ,in general ,each in vitro clinical test developer or importer shall report to the ,secretary any correction or removal of an in vitro clinical test undertaken by such developer or importer if the removal or correction was undertaken-- 7,a7 to reduce the risk to health posed by the in vitro clinical test2 or 7,b7 to remedy a violation of this ,act caused by the in vitro clinical test which may present a risk to health4 7#b7 ,exception ,no report of the correction or removal of an in vitro clinical test is required under paragraph 7#a7 if a report of the correction or removal is required under1 and has been submitted under1 section #ehg,l4 7c7 ,timing ,a developer or importer shall submit any report required under this subsection to the ,secretary within #ae business days of initiating such correction or removal4 7d7 ,recordkeeping ,a developer or importer of an in vitro clinical test who undertakes a correction or removal of an in vitro clinical test which is not required to be reported under this subsection shall keep a record of such correction or removal4 7e7 ,recall communications ,upon the voluntary reporting of a correction or removal by the developer-- 7#a7 the ,secretary shall classify such correction or removal under this section within #ae calendar days2 and 7#b7 not later than #de calendar days after the developer or other responsible party notifies the ,secretary that it has completed a recall action1 the ,secretary shall provide the developer or other responsible party with a written statement closing the recall action or stating the reasons the ,secretary cannot close the recall at that time4 7f7 ,limitation ,the developer is not required to report a correction or removal of an in vitro clinical test based solely on an adverse event report under section #ehg,l that captures an error within the approved performance standards for such test4 7g7 ,definitions ,for purposes of this section-- 7#a7 the term correction means the repair1 modification1 adjustment1 relabeling1 destruction1 or inspection 7including patient monitoring7 of an in vitro clinical test without its physical removal from its point of use to another location1 and does not include routine servicing2 and 7#b7 the term removal means the physical removal of an in vitro clinical test from its point of use to another location for repair1 modification1 adjustment1 relabeling1 destruction1 or inspection1 and does not include routine servicing4 #ehg,n4 ,restricted in vitro clinical tests 7a7 ,applicability 7#a7 ,in general ,the ,secretary1 in issuing an approval of an in vitro clinical test under section #ehg;,b of a category described in paragraph 7#c7 may require that such test be restricted to sale1 distribution1 or use upon such conditions as the ,secretary may prescribe under paragraph 7#b74 7#b7 ,conditions prescribed by the secretary ,the conditions prescribed by the ,secretary under this paragraph1 with respect to an in vitro clinical test described in paragraph 7#c71 are those conditions which the ,secretary determines due to the potentiality for harmful effect of such test 7including any resulting absence1 delay1 or discontinuation of appropriate medical treatment71 are necessary to assure the analytical or clinical validity of the test1 or the safety of a specimen receptacle4 7#c7 ,in vitro clinical tests subject to restrictions ,the restrictions authorized under this section may be applied by the ,secretary to any high-risk in vitro clinical test1 prescription home-use in vitro clinical test1 direct-to-consumer in vitro clinical test1 or over-the-counter in vitro clinical test4 7b7 ,labeling and ,advertising of a ,restricted ,in ,vitro ,clinical ,test ,the label1 labeling1 and advertising of an in vitro clinical test to which restrictions apply under subsection 7a7 shall bear such appropriate statements of the restrictions as the ,secretary may prescribe in the approval1 provisional approval1 technology certification1 or regulation1 as applicable4 7c7 ,requirements prior to enactment ,an in vitro clinical test that was offered1 sold1 or distributed as a restricted device prior to the enactment date of this subchapter shall continue to comply with the applicable restrictions imposed under section #eae or section #ebj7;e7 until the effective date of restrictions issued under subsection 7a74 #ehg,o4 ,appeals 7a7 ,significant decision 7#a7 ,in general ,the ,secretary shall provide a substantive summary of the scientific and regulatory rationale for any significant decision of the ,center for ,devices and ,radiological ,health regarding submission of an application for1 or a review of1 an in vitro clinical test under section #ehg;,b or section #ehg;,d or regarding an exemption under section #ehg;,a1 including documentation of significant controversies or differences of opinion and the resolution of such controversies or differences of opinion4 7#b7 ,provision of documentation ,upon request1 the ,secretary shall furnish a substantive summary described in paragraph 7#a7 to the person who has made1 or is seeking to make1 a submission described in such paragraph4 7#c7 ,application of least burdensome requirements ,the substantive summary required under this subsection shall include a brief statement regarding how the least burdensome requirements were considered and applied consistent with section #ehg;,b7j71 as applicable4 7b7 ,review of significant decisions 7#a7 ,request for supervisory review of significant decision ,any person may request a supervisory review of the significant decision described in subsection 7a77#a74 ,such review may be conducted at the next supervisory level or higher above the agency official who made the significant decision4 7#b7 ,submission of request ,a person requesting a supervisory review under paragraph 7#a7 shall submit such request to the ,secretary not later than #cj days after the decision for which the review is requested and shall indicate in the request whether such person seeks an in-person meeting or a teleconference review4 7#c7 ,timeframe ,the ,secretary shall schedule an in-person or teleconference review1 if so requested1 not later than #cj days after such request is made4 ,the ,secretary shall issue a decision to the person requesting a review under this subsection not later than #de days after the request is made under paragraph 7#a71 or1 in the case of a person who requests an in-person meeting or teleconference1 #cj days after such meeting or teleconference4 7c7 ,advisory panels ,the process established under subsection 7a7 shall permit the appellant to request review by an advisory committee established under section #eac or #ehg;,g4 ,the ,secretary shall provide a response to an appellant under this subsection not later than #de days after the requested advisory committee is convened4 #ehg,p4 ,accredited persons 7a7 ,in ,general 7#a7 ,review of ,applications 7,a7 ,accreditation for application review ,subject to subparagraph 7,c71 during the period beginning on the date of enactment of the ,verifying ,accurate ,leading-edge ,,ivct ,development ,act of #bjbj and ending #b years after the date of enactment of such ,act1 the ,secretary shall accredit persons for any of the following purposes3 7i7 ,reviewing applications for premarket approval under section #ehg;,b and applications for technology certification under section #ehg;,d4 7ii7 ,making recommendations to the ,secretary with respect to an approval of an application under section #ehg;,b or issuance of a technology certification order under section #ehg;,d4 7,b7 ,requirement regarding review recommendations 7i7 ,in general ,in making a recommendation to the ,secretary under this section1 an accredited person shall notify the ,secretary in writing of the reasons for the recommendation concerning the application4 7ii7 ,time period for review ,not later than #cj calendar days after the date on which the ,secretary is notified of a recommendation under this section with respect to an application for premarket approval or technology certification1 the ,secretary shall make a determination with respect to the application4 7,c7 ,lack of applications within #b-year timeframe ,if the ,secretary does not receive applications from persons that meet the criteria under subsection 7c7 within such period1 the ,secretary-- 7i7 may accredit persons under this paragraph after the #b-year period described in subparagraph 7,a72 and 7ii7 shall issue a public notice on the internet website of the ,food and ,drug ,administration calling for applications for such accreditation4 7#b7 ,inspections 7,a7 ,accreditation for inspections ,subject to subparagraph 7,b71 during the period beginning on the date of enactment of the ,verifying ,accurate ,leading-edge ,,ivct ,development ,act of #bjbj and ending #b years after the date of enactment of such ,act1 the ,secretary shall accredit persons for the purpose of conducting inspections of in vitro clinical test developers and other persons required to register pursuant to section #ehg;,i4 7,b7 ,lack of applications within #b-year timeframe ,if no persons who meet the criteria for such accreditation apply during the #b-year period described in subparagraph 7,a71 the ,secretary-- 7i7 may accredit persons under this subparagraph after such period2 and 7ii7 shall issue a public notice on the internet website of the ,food and ,drug ,administration calling for applications for such accreditation4 7,c7 ,effect of accreditation 7i7 ,in general ,persons accredited under subparagraph 7,a7 to conduct inspections1 when conducting such inspections1 shall record in writing their specific observations and shall present their observations to the designated representative of the inspected establishment4 7ii7 ,inspection report requirements ,each person accredited under this paragraph shall prepare and submit to the ,secretary an inspection report in a form and manner designated by the ,secretary for conducting inspections1 taking into consideration the goals of international harmonization of quality systems standards4 ,any official classification of the inspection shall be determined by the ,secretary4 ,any statement or representation made by an employee or agent of an establishment to a person accredited to conduct inspections shall be subject to section #ajja of title #ah1 ,united ,states ,code4 7,d7 ,savings clause ,nothing in this section affects the authority of the ,secretary to inspect any in vitro clinical test developer or other person registered under section #ehg;,i4 7,e7 ,inspection limitations ,the ,secretary shall ensure that inspections carried out under this section are not duplicative of inspections carried out under section #cec of the ,public ,health ,service ,act4 ,inspections under this section shall be limited to the data and information necessary-- 7i7 for routine surveillance activities associated with applications under sections #ehg;,b and #ehg;,d2 or 7ii7 to meet the requirements to receive premarket approval under section #ehg;,b or a technology certification order under section #ehg;,d1 as applicable4 7b7 ,accreditation 7#a7 ,accreditation ,program 7,a7 ,in general ,the ,secretary may provide for accreditation under this section through programs administered by the ,food and ,drug ,administration1 by other non-,federal government agencies1 or by qualified nongovernmental organizations4 ,a person may be accredited for the review of both applications submitted under sections #ehg;,b and #ehg;,d as described in subsection 7a77#a77;,a7 and to conduct inspection activities under subsection 7a77#b77;,a71 or for a subset of such review or activities4 7,b7 ,eligible persons ,not later than #ahj days after the date of enactment of the ,verifying ,accurate ,leading-edge ,,ivct ,development ,act of #bjbj1 the ,secretary shall issue draft guidance on the criteria that the ,secretary will use to accredit or deny accreditation to a person who requests such accreditation under subsection 7a71 and not later than one year after the close of the comment period for the draft guidance issued in this section1 issue final guidance4 7,c7 ,requirements 7i7 ,in general ,the ,secretary shall not accredit or maintain accreditation for a person unless such person meets the minimum qualifications required under subsection 7c74 7ii7 ,scope of accreditation ,the accreditation of a person under this section shall specify the particular activities under subsection 7a7 for which such person is accredited4 7,d7 ,public list ,the ,secretary shall publish on the internet website of the ,food and ,drug ,administration a list of persons who are accredited under this section4 ,such list shall be updated on at least a monthly basis4 ,the list shall specify the particular activity or activities under this section for which the person is accredited4 7#b7 ,accreditation ,process 7,a7 ,accreditation process guidance ,the ,secretary shall-- 7i7 not later than #ahj days after the date of enactment of the ,verifying ,accurate ,leading-edge ,,ivct ,development ,act of #bjbj1 issue draft guidance specifying the process for submitting a request for each type of accreditation and reaccreditation under this section1 including the form and content of information to be submitted in such a request2 and 7ii7 not later than #a year after the close of the comment period for the draft guidance1 issue final guidance4 7,b7 ,response to request ,the ,secretary shall respond to a request for accreditation or reaccreditation within #fj calendar days of the receipt of the request4 ,the ,secretary's response may be to accredit or reaccredit the person1 to deny accreditation1 or to request additional information in support of the request4 ,if the ,secretary requests additional information1 the ,secretary shall respond within #fj calendar days of receipt of such additional information to accredit or deny the accreditation4 7,c7 ,type of accreditation ,the accreditation or reaccreditation of a person shall specify the particular activity or activities under subsection 7a7 for which such person is accredited1 and shall include any limitation to certain eligible in vitro clinical tests4 7,d7 ,audit ,the ,secretary may audit the performance of persons accredited under this section for purposes of ensuring that such persons continue to meet the published criteria for accreditation1 and may modify the scope or particular activities for which a person is accredited if the ,secretary determines that such person fails to meet one or more criteria for accreditation4 7,e7 ,suspension or withdrawal ,the ,secretary may suspend or withdraw accreditation of any person accredited under this section1 after providing notice and an opportunity for an informal hearing1 when such person is substantially not in compliance with the requirements of this section or the published criteria for accreditation1 or poses a threat to public health1 or fails to act in a manner that is consistent with the purposes of this section4 7,f7 ,reaccreditation ,accredited persons may be initially accredited for up to #d years4 ,after expiration of such initial period1 persons may be reaccredited for unlimited additional #d-year periods1 as determined by the ,secretary4 7c7 ,qualifications of accredited ,persons 7#a7 ,eligibility ,an accredited person1 at a minimum1 shall-- 7,a7 not be an employee of the ,federal ,government2 7,b7 not engage in the activities of a developer1 as defined in section #ehg7g72 7,c7 not be a person required to register under section #ehg;,i1 unless such person has established sufficient processes and protocols to separate activities to develop in vitro clinical tests and the activities for which such person would be accredited under subsection 7a7 and discloses applicable information under this section2 7,d7 not be owned or controlled by1 and shall have no organizational1 material or financial affiliation with1 an in vitro clinical test developer or other person required to register under section #ehg;,i2 7,e7 be a legally constituted entity permitted to conduct the activities for which it seeks accreditation2 7,f7 ensure that the operations of such person are in accordance with generally accepted professional and ethical business practices2 and 7,g7 include in its request for accreditation a commitment to1 at the time of accreditation and at any time it is performing activities pursuant to this section-- 7i7 certify that the information reported to the ,secretary accurately reflects the data or protocol reviewed1 and the documented inspection findings1 as applicable2 7ii7 limit work to that for which competence and capacity are available2 7iii7 treat information received or learned1 records1 reports1 and recommendations as proprietary information of the person submitting such information2 and 7iv7 in conducting the activities for which the person is accredited in respect to a particular in vitro clinical test1 protect against the use of any employee or consultant who has a financial conflict of interest regarding that in vitro clinical test4 7#b7 ,waiver ,the ,secretary may waive any requirements in subparagraph 7,a71 7,b71 7,c71 or 7,d7 of paragraph 7#a7 upon making a determination that such person has implemented other appropriate controls sufficient to ensure a competent and impartial review4 7d7 ,compensation of ,accredited ,persons 7#a7 ,in general ,compensation of an accredited person who reviews an application for premarket approval submitted under section #ehg;,b or an application for technical certification submitted under section #ehg;,d shall be determined by agreement between the accredited person and the person who engages the services of the accredited person1 and shall be paid by the person who engages such services4 7#b7 ,inspection accreditation ,compensation of an accredited person who is conducting an inspection under section #gjd shall be determined by agreement between the accredited person and the person who engages the services of the accredited person1 and shall be paid by the person who engages such services4 7e7 ,cooperative ,agreements ,the ,secretary is authorized to enter into cooperative arrangements with officials of foreign countries to ensure that adequate and effective means are available for purposes of determining1 from time to time1 whether in vitro clinical tests intended for use in the ,united ,states by a person whose facility is located outside the ,united ,states shall be refused admission on any of the grounds set forth in section #hja7;a74 7f7 ,information sharing agreements ,an accredited person may enter into an agreement with a test developer to provide information to the comprehensive test information system under section #ehg,t1 including any requirements under section #ehg;,i4 #ehg,q4 ,recognized standards 7a7 ,in general ,the ,secretary may by order establish performance standards for an in vitro clinical test or tests with the same indication for use to provide reasonable assurance of the analytical validity1 clinical validity1 or as applicable safety1 of that in vitro clinical test or tests with the same indications for use4 7b7 ,other standards ,the ,secretary may recognize all or part of appropriate standards established by nationally or internationally recognized standard development organizations for which a person may submit a declaration of conformity in order to meet a requirement under this subchapter to which that standard is applicable4 ,in recognizing a standard1 any person requesting recognition of a standard or seeking to use a recognized standard1 the ,secretary shall follow the processes and requirements1 in accordance with section #ead7;c74 ,standards for in vitro diagnostic devices previously recognized under section #ead7;c7 shall be considered recognized standards under this section4 ,the application of any such consensus standard shall only apply prospectively4 ,the ,secretary shall issue guidance establishing the criteria and process for such recognition and adoption4 7c7 ,order process ,in establishing a standard under subsection 7a71 the ,secretary shall issue a draft order proposing to establish a standard and shall provide for a comment period of not less than #fj calendar days4 ,the ,secretary may choose to seek the recommendation of an advisory committee under section #ehg;,g concerning a proposed standard either prior to or after issuance of a proposed order4 ,after considering the comments and within #ij days of the close of the comment period1 the ,secretary shall issue a final order adopting the proposed standard1 adopting a modification of the proposed standard or terminating the proceeding4 7d7 ,amendment process ,the procedures established in this section or in guidance issued under this section shall apply to amendment of an existing standard4 #ehg,r4 ,investigational use 7a7 ,in general ,except as provided in subsection 7c71 an in vitro clinical test for investigational use shall be exempt from the requirements of this subchapter other than sections #ehg;,a1 #ehg,o1 and #ehg,u4 7b7 ,regulations ,not later than #b years after the date of enactment of the ,verifying ,accurate ,leading-edge ,,ivct ,development ,act of #bjbj1 the ,secretary shall promulgate regulations to implement this section4 7c7 ,application for investigational use 7#a7 ,in general ,the following shall apply with respect to in vitro clinical tests for investigational use3 7,a7 ,streamlining applications submitted under this section ,requirements with respect to such tests shall be completed in accordance with current investigational use requirements for institutional review boards and current processes for any analytical or clinical validation4 7,b7 ,variation ,the requirements in the regulations promulgated under this section shall take into account variations based on-- 7i7 the scope and duration of clinical testing to be conducted under investigation that is the subject of such application2 7ii7 the number of human subjects that are to be involved in such testing2 7iii7 the need to permit changes to be made in the in vitro clinical test involved during testing conducted in accordance with a plan required under paragraph 7#c77;,b72 or 7iv7 whether the clinical testing of such in vitro clinical test is for the purpose of developing data to obtain approval to offer such test4 7,c7 ,significant risk studies ,in the case of an in vitro clinical test the investigational use of which poses a significant risk1 a sponsor of an investigation of such a test seeking an investigational use exemption shall submit to the ,secretary an investigational use application with respect to the test in accordance with paragraphs 7#b7 and 7#c74 ,for purposes of this subparagraph1 the term significant risk means1 with respect to an in vitro clinical test that is a high-risk test1 and that the use of the test-- 7i7 is a use of substantial importance in performing an activity or activities described in subsection 7ss77#a77;,a7 for1 a serious or life-threatening disease or condition without confirmation of the diagnosis by a medically established means2 7ii7 requires an invasive sampling procedure that presents a significant risk to the human subject2 or 7iii7 otherwise presents a reasonably foreseeable serious risk to the health of a human subject4 7,d7 ,non-significant risk tests ,in the case of an in vitro clinical test1 the investigational use of which does not pose a significant risk-- 7i7 the sponsor of such investigation shall-- 7,i7 conduct such investigation in compliance with an investigational plan specified in paragraph 7#e7 and labeling specified in paragraph 7#c77;,a77ii72 7,,ii7 ensure each investigator obtains informed consent under part #ej of title #ba1 ,code of ,federal ,regulations 7or any successor regulations71 subject to the exceptions set forth in paragraphs 7#e77;,a77iii7 and 7#e77;,b72 7,,iii7 submit a listing to the ,secretary of such investigation2 and 7,,iv7 maintain records with respect to all requirements in this subparagraph2 and 7ii7 the sponsor may rely on any exception or exemption identified in paragraph 7#e77;,b7 or as established by the ,secretary in regulations issued under subsection 7b74 7#b7 ,application content ,an investigational use application shall be submitted in such time and manner and contain such information as the ,secretary may require in regulation1 and shall include an investigational plan for proposed clinical testing and assurances that the sponsor submitting the application will-- 7,a7 establish and maintain records relevant to the investigation of such in vitro clinical test2 and 7,b7 submit to the ,secretary annual reports of data obtained as a result of the investigational use of the in vitro clinical test during the period covered by the exemption that the ,secretary reasonably determines will enable the ,secretary-- 7i7 to ensure compliance with the conditions for approval specified in paragraph 7#c72 7ii7 to review the progress of the investigation involved2 and 7iii7 to evaluate the analytical validity and clinical validity of such test4 7#c7 ,conditions of approval 7,a7 ,in general ,an investigational use application with respect to significant risk tests shall only be approved if each of the following conditions is met3 7i7 ,the risks to the subjects of the in vitro clinical test are outweighed by the anticipated benefits to the subjects and the importance of the knowledge to be gained1 and adequate assurance of informed consent is provided in accordance with paragraph 7#e77;,a77iii74 7ii7 ,the proposed labeling for the in vitro clinical test involved clearly and conspicuously states ,for investigational use4 7iii7 ,such other requirements the ,secretary determines to be necessary for the protection of the public health and safety as long as the requirements do not unduly delay investigation after finding that the results of such investigation establish sufficient data to support clinical or analytical validity4 7,b7 ,certain significant risk in vitro clinical tests for an unmet need ,as a condition of approval under this paragraph1 the ,secretary shall not impose a limit on the sample size for a significant risk in vitro clinical test that meets the requirements of section #ehg;,c1 as long as such test is developed within a laboratory that is certified to conduct high-complexity testing under section #cec of the ,public ,health ,service ,act4 7#d7 ,coordination with investigational new drug applications ,any requirement for the submission of a report to the ,secretary pursuant to an investigational new drug application involving an in vitro clinical test shall supersede the reporting requirement in paragraph 7#b77;,b71 but only to the extent the requirement with respect to the investigational new drug application is duplicative of the reporting requirement under such paragraph4 7#e7 ,investigation plan requirements 7,a7 ,in general ,with respect to an investigational plan submitted under paragraph 7#b77;,a71 the sponsor submitting such plan shall-- 7i7 in the case of such a plan submitted to an institutional review committee1 promptly notify the ,secretary of the approval or the suspension or termination of the approval of such plan by an institutional review committee2 7ii7 in the case of an in vitro clinical test made available to investigators for clinical testing1 assurance that all investigators will comply with this section1 regulations promulgated or revised under this section1 and applicable human subjects regulations2 and 7iii7 submit an assurance to the ,secretary that informed consent will be obtained from each human subject 7or the representative of such subject7 of proposed clinical testing involving such in vitro clinical test1 except in the case that-- 7,i7 there is a life-threatening situation involving the human subject of such testing which necessitates the use of such in vitro clinical test2 7,,ii7 it is not feasible to obtain informed consent from the subject2 and 7,,iii7 there is not sufficient time to obtain such consent from a representative of such subject4 7,b7 ,exception ,the informed consent of human subjects shall not be required with respect to clinical testing conducted as part of an investigation1 if-- 7i7 the clinical testing uses remnants of specimens collected for routine clinical care or analysis that would have been discarded1 leftover specimens that were previously collected for other research purposes1 or specimens obtained from specimen repositories2 7ii7 the identity of the subject of the specimen is not known to1 and may not readily be ascertained by1 the investigator or any other individual associated with the investigation1 including the sponsor2 7iii7 any clinical information that accompanies the specimens does not make the specimen source identifiable to the investigator or any other individual associated with the investigation1 including the sponsor2 7iv7 the individuals caring for the human subjects as patients are different from1 and do not share information about the patient with1 the individuals conducting the investigation2 and 7v7 the specimens are provided to the investigators without personally identifiable information and the supplier of the specimens has established policies and procedures to prevent the release of personally identifiable information4 7d7 ,review of applications 7#a7 ,in general ,the ,secretary may issue an order approving an investigation as proposed1 approving it with conditions or modifications1 or disapproving it4 7#b7 ,failure to act ,unless the ,secretary1 not later than the date that is #cj calendar days after the date of the submission of an investigational use application that meets the requirements of subsection 7c77#b71 issues an order under subsection 7d77#a7 and notifies the sponsor submitting the application1 the application shall be treated as approved as of such date without further action by the ,secretary4 7#c7 ,disapproval ,the ,secretary may disapprove an investigational use application submitted under this subsection if the ,secretary determines that the investigation with respect to which the application is submitted does not conform to the requirements of subsection 7c77#c74 ,a listing of such disapproval submitted to the sponsor with respect to such an application shall contain the order of disapproval and a complete statement of the reasons for the ,secretary's disapproval of the application4 7e7 ,withdrawal of approval 7#a7 ,in general ,the ,secretary may1 by administrative order1 withdraw the approval of an exemption granted under this section with respect to an in vitro clinical test1 including an exemption granted based on the ,secretary's failure to act pursuant to subsection 7d77#b71 if the ,secretary determines that the test does not meet the applicable conditions under subsection 7c77#c7 for such approval4 7#b7 ,opportunity to be heard 7,a7 ,in general ,subject to subparagraph 7,b71 an order withdrawing the approval of an exemption granted under this section may be issued only after the ,secretary provides the applicant or sponsor of the test with an opportunity for an informal hearing4 7,b7 ,exception ,an order referred to in subparagraph 7,a7 with respect to an exemption granted under this subsection may be issued on a preliminary basis before the provision of an opportunity for an informal hearing if the ,secretary determines that the continuation of testing under the exemption will result in an unreasonable risk to the public health4 ,the ,secretary will provide an opportunity for an informal hearing promptly following any preliminary action under this subparagraph4 7f7 ,changes 7#a7 ,in general ,the regulations promulgated under subsection 7b7 shall provide1 with respect to an in vitro clinical test for which an exemption under this subsection is in effect1 procedures and conditions under which the changes to the test are allowed without the additional approval of an application for an exemption or the approval of a supplement to such an application4 ,such regulations shall provide that such a change may be made if-- 7,a7 the sponsor or applicant determines1 on the basis of credible information 7as defined by the ,secretary7 that the change meets the conditions specified in paragraph 7#b72 and 7,b7 the sponsor or applicant submits to the ,secretary1 not later than #e calendar days after making the change1 a notice of the change4 7#b7 ,conditions ,the conditions specified in this paragraph are that-- 7,a7 in the case of developmental changes to an in vitro clinical test 7including manufacturing changes71 the changes-- 7i7 do not constitute a significant change in design or in basic principles of operation2 7ii7 do not affect the rights1 safety1 or welfare of the human subjects 7if any7 involved in the investigation2 and 7iii7 are made in response to information gathered during the course of an investigation2 and 7,b7 in the case of changes to clinical protocols applicable to the test1 the changes do not affect-- 7i7 the validity of data or information resulting from the completion of an approved clinical protocol2 7ii7 the scientific soundness of a plan submitted under subsection 7c77#e72 or 7iii7 the rights1 safety1 or welfare of the human subjects 7if any7 involved in the investigation4 7g7 ,clinical hold 7#a7 ,in general ,at any time1 the ,secretary may impose a clinical hold with respect to an investigation of an in vitro clinical test if the ,secretary makes a determination described in paragraph 7#b74 ,the ,secretary shall1 in imposing such clinical hold1 specify the basis for the clinical hold1 including the specific information available to the ,secretary which served as the basis for such clinical hold1 and confirm such determination in writing4 ,the applicant or sponsor may immediately appeal any such determination pursuant to section #ehg,o4 7#b7 ,determination ,for purposes of paragraph 7#a71 a determination described in this subparagraph with respect to a clinical hold is a determination that-- 7,a7 the in vitro clinical test involved represents an unreasonable risk to the safety of the persons who are the subjects of the clinical investigation1 taking into account the qualifications of the clinical investigators1 information about the in vitro clinical test1 the design of the clinical investigation1 the condition for which the in vitro clinical test is to be investigated1 and the health status of the subjects involved2 7,b7 the clinical hold should be issued for such other reasons as the ,secretary may by regulation establish2 or 7,c7 any written request to the ,secretary from the sponsor of an investigation that a clinical hold be removed shall receive a decision1 in writing and specifying the reasons therefor1 within #cj days after receipt of such request4 ,any such request shall include sufficient information to support the removal of such clinical hold4 #ehg,s4 ,collaborative communities for in vitro clinical tests 7a7 ,in general 7#a7 ,for the purposes of facilitating community solutions and decision making with respect to in vitro clinical tests1 the ,secretary may participate in collaborative communities comprised of public and private participants that may provide recommendations and other advice to the ,secretary on the development and regulation of in vitro clinical tests4 7#b7 ,a collaborative community under this section shall have broad representation of interested private and public-sector stakeholder communities and may include patients1 care partners1 academics1 healthcare professionals1 healthcare systems1 payers1 ,federal and ,state agencies1 entities responsible for accrediting clinical laboratories1 international regulatory bodies1 test developers1 or other interested entities or communities4 7b7 ,guidance ,the ,secretary shall issue a draft guidance not later than #ahj days after the date of enactment of the ,verifying ,accurate ,leading-edge ,,ivct ,development ,act of #bjbj1 addressing the participation process and framework to build consensus1 and how the ,secretary may consider1 review1 and implement recommendations under subsection 7c74 7c7 ,recommendations ,a collaborative community for in vitro clinical tests may make recommendations to the ,secretary on matters including-- 7#a7 mitigating measures for in vitro clinical tests2 7#b7 standards development activities and performance standards for in vitro clinical tests or groups of such tests2 7#c7 scientific and clinical evidence to support new claims for in vitro clinical tests2 7#d7 new technologies and methodologies related to in vitro clinical tests2 7#e7 stakeholder communication and engagement2 and 7#f7 development of effective policies and processes1 including to develop tests1 and to regulate such tests in accordance with least burdensome principals under this ,act4 7d7 ,use by ,secretary 7#a7 ,in general ,the ,secretary may adopt recommendations made under subsection 7b71 or otherwise incorporate the feedback from collaborative communities into regulatory decision making1 through rulemaking or guidance1 as appropriate4 7#b7 ,clarification ,the ,secretary is not required to adopt recommendations submitted by collaborative communities4 7e7 ,transparency ,the ,secretary shall-- 7#a7 publish on the internet website of the ,food and ,drug ,administration matters for which it is seeking comments or recommendations1 in a timely manner2 7#b7 maintain a list of all collaborative communities in which the ,secretary participates and make such list available on the internet website of the ,food and ,drug ,administration2 and 7#c7 post on the internet website of the ,food and ,drug ,administration at least once every year a report on the recommendations it has adopted and recommendations it has not adopted from collaborative communities4 7f7 ,participation ,the ,secretary may participate in a collaborative community only if such community requires members to disclose conflicts of interest and has established a process to address conflicts of interest4 7g7 ,exception ,the ,federal ,advisory ,committee ,act in the appendix to title #e shall not apply to collaborative communities established and used in accordance with this section4 #ehg,t4 ,comprehensive test information system 7a7 ,purpose ,for the purposes of improving the transparency of information on in vitro clinical tests and allowing patients and health care providers better access to information about in vitro clinical tests1 the ,secretary shall establish a comprehensive test information system4 7b7 ,establishment ,not later than #b years after the date of enactment of the ,verifying ,accurate ,leading-edge ,,ivct ,development ,act of #bjbj1 the ,secretary shall make available a comprehensive test information system for in vitro clinical tests that is designed to-- 7#a7 provide a transparent interface on the internet website of the ,food and ,drug ,administration for stakeholders1 to the extent permitted by applicable law1 to access the-- 7,a7 regulatory pathway designation information for each in vitro clinical test or tests with the same indications for use2 7,b7 registration and listing information provided by developers under section #ehg;,i1 including the use of a link for labels2 7,c7 adverse event reports submitted under section #ehg,l2 7,d7 reports of corrections and removals submitted under section #ehg,m2 and 7,e7 other information pertaining to an in vitro clinical test or tests with the same indications for use1 as the ,secretary determines appropriate2 and 7#b7 provide a secure portal for electronic submission1 including applications and other in vitro clinical test submissions1 registration and listing information1 and adverse event reports4 7c7 ,submission function ,the comprehensive test information system shall serve as the electronic submission service for test developers submitting information for applications under sections #ehg;,b and #ehg;,d4 #ehg,u4 ,preemption 7a7 ,in general ,no ,state1 tribal1 or local government 7or political subdivision thereof7 may establish or continue in effect any requirement related to the development1 manufacture1 labeling1 distribution1 sale1 or use of an in vitro clinical test that is different from1 or in addition to1 the requirements of this subchapter4 7b7 ,exceptions ,subsection 7a7 shall not be construed to affect the authority of a ,state1 tribal1 or local government-- 7#a7 to license laboratory personnel1 health care practitioners1 or health care facilities or to regulate any aspect of a health care practitioner-patient relationship2 or 7#b7 to enforce laws of general applicability1 such as zoning laws1 environmental laws1 labor laws1 and general business laws4 7c7 ,clarification ,this section shall not be construed to shift liability to health care practitioners or other users4 #ehg,v4 ,adulteration ,an in vitro clinical test shall be deemed to be adulterated3 7#a7 ,if it consists in whole or in part of any filthy1 putrid1 or decomposed substance4 7#b7 ,if it has been developed1 prepared1 packed1 or held under insanitary conditions whereby it may have been contaminated with filth1 or whereby it may have been rendered injurious to health4 7#c7 ,if its container or package is composed1 in whole or in part1 of any poisonous or deleterious substance which may render the contents injurious to health4 7#d7 ,if it bears or contains1 for purposes of coloring only1 a color additive which is unsafe within the meaning of section #gba7;a74 7#e7 ,if its analytical or clinical validity1 or with respect to a specimen receptacle1 its safety1 or its strength1 purity1 or quality1 differs from or falls below that which it purports or is represented to possess4 7#f7 ,if it is required to be1 declared to be1 purports to be1 or is represented as being1 in conformity with any performance standard established or recognized under section #ehg,q and is not in all respects in conformity with such standard4 7#g7 ,if it is required to be in conformity with a mitigating measure established under section #ehg;,e and is not in all respects in conformity with such mitigating measure4 7#h7 ,if it fails to have an approved premarket application under section #ehg;,b unless such in vitro clinical test can be lawfully offered-- 7,a7 for clinical use pursuant to an exemption under section #ehg;,a2 7,b7 for emergency use pursuant to an authorization under section #efd2 or 7,c7 for investigational use pursuant to section #ehg,r4 7#i7 ,if it is not in conformity with any condition established under section #ehg;,b1 #ehg;,d1 or #efd4 7#aj7 ,if it purports to be an in vitro clinical test that is offered for clinical use subject to an exemption under section #ehg;,a and it fails to meet or maintain any criteria1 condition1 or requirement of such exemption4 7#aa7 ,if it has been granted an exemption under section #ehg,r for investigational use1 and the person granted such exemption or any investigator who uses such in vitro clinical test under such exemption fails to comply with a requirement prescribed by or under such section4 7#ab7 ,if it fails to meet the quality requirements prescribed in or established under section #ehg;,j 7as applicable71 or the methods used in1 or facilities or controls used for1 its development1 manufacture1 packing1 storage1 or installation are not in conformity with applicable requirements established under such section4 7#ac7 ,if it has been developed1 manufactured1 processed1 packed or held in any establishment1 factory1 or warehouse and the owner1 operator or agent of such establishment1 factory1 or warehouse delays1 denies1 or limits an inspection1 or refuses to permit entry or inspection4 7#ad7 ,if it is not in compliance with any restriction required under section #ehg,n4 #ehg,w4 ,misbranding ,an in vitro clinical test shall be deemed to be misbranded3 7#a7 ,if its labeling is false or misleading in any particular4 7#b7 ,if in a package form unless it bears a label containing-- 7,a7 the name and place of business of the test developer1 manufacturer1 packer1 or distributor2 and 7,b7 an accurate statement of the quantity of contents in terms of weight1 measure1 or numerical count with respect to small packages1 unless an exemption is granted by the ,secretary by the issuance of guidance4 7#c7 ,if any word1 statement1 or other information required by or under authority of this ,act to appear on the label or labeling1 including a test report1 is not prominently placed thereon with such conspicuousness 7as compared with other words1 statements1 designs1 or devices1 in the labeling7 and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use4 7#d7 ,unless its labeling bears adequate directions for use and such adequate warnings as are necessary for the protection of users of the in vitro clinical test and recipients of the results of such in vitro clinical test1 including patients1 consumers1 donors1 and related health care professionals4 ,required labeling for in vitro clinical tests intended for use in health care facilities or by a health care professional may be made available solely by electronic means1 provided that the labeling complies with all applicable requirements of law1 and that the test developer1 manufacturer1 or distributor affords such users the opportunity to request the labeling in paper form1 and after such request1 promptly provides the requested information without additional cost4 7#e7 ,if it causes serious or adverse health consequences or death1 including through absence1 delay1 or discontinuation in diagnosis or treatment1 when used in the manner prescribed1 recommended1 or suggested in the labeling thereof4 7#f7 ,if it was developed or manufactured in an establishment not duly registered under section #ehg;,i or it was not included in a listing under section #ehg;,i1 in accordance with timely reporting requirements under this subchapter4 7#g7 ,in the case of any in vitro clinical test subject to restrictions under section #ehg,n1 7#a7 if its advertising is false or misleading in any particular1 7#b7 if it is offered for clinical use1 sold1 distributed1 or used in violation of such restrictions1 or 7#c7 unless the test developer1 manufacturer1 or distributor includes in all advertisements and other descriptive printed matter that such person issues or causes to be issued1 a brief statement of the intended uses of the in vitro clinical test and relevant warnings1 precautions1 side effects1 and contraindications4 ,this subsection shall not be applicable to any printed matter that the ,secretary determines to be labeling as defined in section #bja7m7 or section #ehg,k4 7#h7 ,if it was subject to a mitigating measure established under section #ehg;,e1 unless it bears such labeling as may be prescribed in such mitigating measure4 7#i7 ,if it was subject to a standard established under section #ehg,q1 unless it bears such labeling as may be prescribed in such standard4 7#aj7 ,unless it bears such labeling as may be prescribed by or established under an applicable labeling requirement under this ,act4 7#aa7 ,if there was a failure or refusal to comply with any requirement prescribed under section #ehg;,i or #ehg,x1 or to comply with a requirement under section #ehg,y1 or to provide any report1 material1 or information required under this subchapter4 #ehg,x4 ,postmarket surveillance 7a7 ,in general 7#a7 ,in general ,in addition to other applicable requirements under this ,act1 the ,secretary may issue an order requiring a developer to conduct postmarket surveillance of a single in vitro clinical test as a condition of approval under section #ehg;,b4 7#b7 ,exempt tests ,the ,secretary may order postmarket surveillance for tests exempt pursuant to section #ehg;,a for which the failure of the in vitro clinical test to meet the applicable standard for approval is likely to result in serious or adverse health consequences or death from use of the single in vitro clinical test4 7#c7 ,consideration ,in determining whether to require a developer to conduct postmarket surveillance of an in vitro clinical test1 the ,secretary shall take into consideration the benefits and risks for the patient and the least burdensome principles under section #ehg;,b4 7b7 ,surveillance approval 7#a7 ,each developer required to conduct a surveillance of an in vitro clinical test shall submit1 within #cj days of receiving an order from the ,secretary1 a plan for the required surveillance4 ,the ,secretary1 within #fj days of the receipt of such plan1 shall determine if the person designated to conduct the surveillance has the appropriate qualifications and experience to undertake such surveillance and if the plan will result in useful data that can reveal unforeseen adverse events or other information necessary to protect the health of patients or the public4 7#b7 ,the developer shall commence surveillance under this section not later than #ae months after the day on which the ,secretary orders such postmarket surveillance1 unless the ,secretary determines more time is needed to commence surveillance4 7#c7 ,the ,secretary may order a prospective surveillance period of up to #c years4 ,any determination by the ,secretary that a longer period is necessary shall be made by mutual agreement between the ,secretary and the manufacturer or1 if no agreement can be reached1 after the completion of a dispute resolution process4 #ehg,y4 ,electronic format for submissions 7a7 ,in general ,all presubmissions and submissions to the ,food and ,drug ,administration with respect to an in vitro clinical test shall include an electronic copy of such presubmission or submission1 and1 with respect to the information required under sections #ehg;,b and #ehg;,d1 shall utilize the system described in section #ehg,t4 7b7 ,electronic format ,beginning on such date as the ,secretary specifies in final guidance issued under subsection 7c71 presubmissions and submissions for in vitro clinical tests 7and any appeals of action taken by the ,secretary with respect to such presubmissions and submissions7 shall be submitted solely in such electronic format as specified by the ,secretary in such guidance4 7c7 ,guidance ,the ,secretary shall issue guidance implementing this section4 ,in such guidance1 the ,secretary may-- 7#a7 provide standards for the electronic copy required under subsection 7a7 or the submission in electronic format required under subsection 7b72 7#b7 set forth criteria for waivers of or exemptions from the requirements of subsection 7a7 or 7b72 and 7#c7 provide any other information for the efficient implementation and enforcement of this section4 #ehg,z4 ,postmarket remedies 7a7 ,safety ,notice 7#a7 ,in general ,if the ,secretary determines that an in vitro clinical test presents an unreasonable risk of substantial harm to the public health1 and notification under this subsection is necessary to eliminate the unreasonable risk of such harm and no more practicable means is available under the provisions of this ,act 7other than this section7 to eliminate the risk1 the ,secretary may issue such order as may be necessary to ensure that adequate safety notice is provided in an appropriate form1 by the persons and means best suited under the circumstances1 to all health care professionals who prescribe1 order1 or use the in vitro clinical test and to any other person 7including developers1 manufacturers1 importers1 distributors1 retailers1 and users7 who should properly receive such notice4 7#b7 ,notice to individuals ,an order under this subsection shall require that the individuals subject to the risk with respect to which the order is to be issued be included in the persons to be notified of the risk unless the ,secretary determines that notice to such individuals would present a greater danger to the health of such individuals than no such notice4 ,if the ,secretary makes such a determination with respect to such individuals1 the order shall advise the health care professionals who prescribed1 ordered1 or used the in vitro clinical test provide notification to the individuals for whom the health professionals prescribed1 ordered1 or used such test1 of the risk presented by such in vitro clinical test and of any action which may be taken by or on behalf of such individuals to eliminate or reduce such risk4 ,before issuing an order under this subsection1 the ,secretary shall consult with the persons required to give notice under the order4 7b7 ,repair1 ,replacement1 or ,refund 7#a7 ,determination after an informal hearing 7,a7 ,in general ,if1 after affording opportunity for an informal hearing1 the ,secretary determines that-- 7i7 an in vitro clinical test presents an unreasonable risk of substantial harm to the public health2 7ii7 there are reasonable grounds to believe that the in vitro clinical test was not properly developed or manufactured considering the state of the art as it existed at the time of its development or manufacture2 7iii7 there are reasonable grounds to believe that the unreasonable risk was not caused by failure of a person other than a developer1 manufacturer1 importer1 distributor1 or retailer of the in vitro clinical test to exercise due care in the installation1 maintenance1 repair1 or use of the in vitro clinical test2 and 7iv7 the notice authorized by subsection 7a7 would not by itself be sufficient to eliminate the unreasonable risk and action described in paragraph 7#b7 of this subsection is necessary to eliminate such risk1 the ,secretary may order the developer1 manufacturer1 importer1 or any distributor of such in vitro clinical test1 or any combination of such persons1 to submit to him within a reasonable time a plan for taking one or more of the actions described in paragraph 7#b74 ,an order issued under the preceding sentence which is directed to more than one person shall specify which person may decide which action shall be taken under such plan and the person specified shall be the person who the ,secretary determines bears the principal1 ultimate financial responsibility for action taken under the plan unless the ,secretary cannot determine who bears such responsibility or the ,secretary determines that the protection of the public health requires that such decision be made by a person 7including a health professional or user of the in vitro clinical test7 other than the person the ,secretary determines bears such responsibility4 7,b7 ,secretary approval of plan ,within #cj calendar days of issuing an order under subparagraph 7,a71 the ,secretary shall approve a plan submitted pursuant to an order issued under subparagraph 7,a7 unless the ,secretary determines 7after affording opportunity for an informal hearing7 that the action or actions to be taken under the plan or the manner in which such action or actions are to be taken under the plan will not assure that the unreasonable risk with respect to which such order was issued will be eliminated4 ,if the ,secretary disapproves a plan1 the ,secretary shall order a revised plan to be submitted within a reasonable time4 ,if the ,secretary determines 7after affording opportunity for an informal hearing7 that the revised plan is unsatisfactory or if no revised plan or no initial plan has been submitted to the ,secretary within the prescribed time1 the ,secretary shall 7i7 prescribe a plan to be carried out by the person or persons to whom the order issued under subparagraph 7,a7 was directed1 or 7ii7 after affording an opportunity for an informal hearing1 by order prescribe a plan to be carried out by a person who is a manufacturer1 importer1 distributor1 or retailer of the in vitro clinical test with respect to which the order was issued but to whom the order under subparagraph 7,a7 was not directed4 7#b7 ,actions on a plan ,the actions which may be taken under a plan submitted under an order issued under paragraph 7#a7 are as follows3 7,a7 ,to repair the in vitro clinical test so that it does not present the unreasonable risk of substantial harm with respect to which the order under paragraph 7#a77;,a7 was issued4 7,b7 ,to replace the in vitro clinical test with a like or equivalent test which is in conformity with all applicable requirements of this ,act4 7,c7 ,to refund the purchase price of the in vitro clinical test 7less a reasonable allowance for use if such in vitro clinical test has been in the possession of the user for one year or more at the time of notice ordered under subsection 7a71 or at the time the user receives actual notice of the unreasonable risk with respect to which the order was issued under paragraph 7#a77;,a71 whichever occurs first74 7#c7 ,no charge ,no charge shall be made to any person 7other than a developer1 manufacturer1 importer1 distributor or retailer7 for using a remedy described in paragraph 7#b7 and provided under an order issued under paragraph 7#a71 and the person subject to the order shall reimburse each person 7other than a developer1 manufacturer1 importer1 distributor1 or retailer7 who is entitled to such a remedy for any reasonable and foreseeable expenses actually incurred by such person in availing himself of such remedy4 7c7 ,reimbursement ,an order issued under subsection 7b77#a77;,a7 with respect to an in vitro clinical test may require any person who is a developer1 manufacturer1 importer1 distributor1 or retailer of the in vitro clinical test to reimburse any other person who is a developer1 manufacturer1 importer1 distributor1 or retailer of such in vitro clinical test for such other person's expenses actually incurred in connection with carrying out the order if the ,secretary determines such reimbursement is required for the protection of the public health4 ,any such requirement shall not affect any rights or obligations under any contract to which the person receiving reimbursement or the person making such reimbursement is a party4 7d7 ,recall ,authority 7#a7 ,in general ,if the ,secretary finds that there is a reasonable probability that an in vitro clinical test approved under section #ehg;,b would cause serious1 adverse health consequences or death1 including by the absence1 delay1 or discontinuation of appropriate medical treatment1 the ,secretary shall issue an order requiring the appropriate person 7including the developers1 manufacturers1 importers1 distributors1 or retailers of the in vitro clinical test7-- 7,a7 to immediately cease distribution of such in vitro clinical test2 and 7,b7 to immediately notify health professionals and user facilities of the order and to instruct such professionals and facilities to cease use of such in vitro clinical test4 7#b7 ,informal hearing ,the order issued under paragraph 7#a77;,a71 shall provide the person subject to the order with an opportunity for an informal hearing1 to be held not later than #aj calendar days after the date of the issuance of the order1 on the actions required by the order and on whether the order should be amended to require a recall of such in vitro clinical test4 ,if1 after providing an opportunity for such a hearing1 the ,secretary determines that inadequate grounds exist to support the actions required by the order1 the ,secretary shall vacate the order4 7#c7 ,amended order 7,a7 ,in general ,if1 after providing an opportunity for an informal hearing under paragraph 7#b71 the ,secretary determines that the order should be amended to include a recall of the in vitro clinical test with respect to which the order was issued1 the ,secretary shall1 except as provided in subparagraph 7,b71 amend the order to require a recall4 ,the ,secretary shall specify a timetable in which the recall will occur and shall require periodic reports describing the progress of the recall4 7,b7 ,requirements ,an amended order under subparagraph 7,a7-- 7i7 shall not include recall of the in vitro clinical test from individuals2 7ii7 shall not include recall of an in vitro clinical test from test user facilities if the ,secretary determines that the risk of recalling such in vitro clinical test from the facilities presents a greater health risk than the health risk of not recalling the in vitro clinical test from use2 and 7iii7 shall provide for notice to individuals subject to the risks associated with the use of such in vitro clinical test4 ,in providing the notice required by this clause1 the ,secretary may use the assistance of health professionals who prescribed1 ordered1 or used such an in vitro clinical test for individuals4 7#d7 ,clarification ,the remedy provided by this subsection shall be in addition to remedies provided by subsections 7b7 and 7c74 4 #d4 ,enforcement and other provisions 7a7 ,prohibited acts ,section #cja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7 is amended-- 7#a7 in paragraphs 7a71 7b71 7c71 7g71 7k71 7q71 7r71 and 7y71 by inserting in vitro clinical test1 after device1 each place it appears2 7#b7 in paragraph 7y7 by inserting or #ehg,p after section #ebc each place it appears2 and 7#c7 by adding at the end1 the following3 7fff7 7#a7 ,the introduction or delivery for introduction into interstate commerce of an in vitro clinical test in violation of section #ehg;,b7a74 7#b7 ,the false1 fraudulent1 or deceptive claiming for an in vitro clinical test of an exemption from the premarket review required under section #ehg;,b4 7#c7 ,when claiming an exemption under section #ehg;,a from the premarket review required under section #ehg;,b1 the failure to maintain complete and accurate documentation for the exemption as required under section #ehg;,a or the failure to provide labeling required under section #ehg;,a4 7#d7 ,with respect to an in vitro clinical test1 the submission of any report that is required by or under this ,act that is false or misleading in any material respect4 7#e7 ,the making of a false1 fraudulent1 or materially deceptive analytical or clinical claim for an in vitro clinical test-- 7,a7 in any application1 report1 or notification submitted to the ,secretary under this ,act2 or 7,b7 in the labeling or advertising of an in vitro clinical test4 7#f7 ,the failure to comply with a condition of approval1 performance standard1 mitigating measure1 or restriction established in an order approving an application or supplement under section #ehg;,b2 the failure to perform a risk analysis required by section #ehg;,b2 the failure to submit an annual report required under section #ehg;,b7k72 or the failure to complete postmarket studies required under section #ehg,v4 7#g7 ,the marketing of an in vitro clinical test in violation of-- 7,a7 an order issued by the ,secretary under section #ehg;,a2 or 7,b7 any requirement under section #ehg;,a4 7#h7 ,with respect to technology certification under section #ehg;,d1 the refusal to permit1 or unreasonable delay in permitting1 an inspection authorized under section #ehg;,d7f77#c77;,g72 the failure to comply with applicable requirements to submit an application or report under section #ehg;,d7e72 or the failure to comply with applicable maintenance requirements under section #ehg;,d7h74 7#i7 ,the failure to comply with an applicable mitigating measure established under section #ehg;,e or to maintain the documentation required under section #ehg;,e7b72 or the failure to comply with a performance standard established under section #ehg,q4 7#aj7 ,the failure to register in accordance with section #ehg;,i1 the failure to provide information required under section #ehg;,i7b71 or the failure to maintain or submit information required under section #ehg;,i7c74 7#aa7 ,the failure to submit a report required under section #ehg,l or #ehg,m2 the failure to comply with a restriction imposed under section #ehg,n2 or the failure to comply with labeling and advertising requirements under section #ehg,n7b74 7#ab7 ,the failure to comply with the requirements of section #ehg,p 7relating to accredited persons74 7#ac7 ,the failure to comply with any requirement prescribed or established under section #ehg,r2 the failure to furnish any notification1 information1 material1 or report required under section #ehg,r2 or the failure to comply with an order issued under section #ehg,r4 4 7b7 ,penalties ,section #cjc7;f77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7;f77#a77 is amended-- 7#a7 in subparagraph 7,a71 by inserting or in vitro clinical tests after devices2 and 7#b7 in subparagraph 7,b77i7-- 7,a7 by inserting 1 or #ehg;,j or #ehg,l1 after #ebj7;f72 and 7,b7 by inserting 1 or who violates section #ehg,m7b7 with respect to a correction report after risk to public health4 7c7 ,seizure ,section #cjd of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ccd7 is amended-- 7#a7 in subsection 7a77#b7-- 7,a7 by striking and before 7,e7 ,any2 and 7,b7 by inserting 1 and 7,f7 ,any adulterated or misbranded in vitro clinical test after tobacco product2 7#b7 in subsection 7d77#a71 by inserting in vitro clinical test1 after device12 and 7#c7 in subsection 7g7-- 7,a7 in paragraph 7#a71 by inserting 1 in vitro clinical test1 after device each place it appears2 and 7,b7 in paragraph 7#b7-- 7i7 in subparagraph 7,a71 by inserting 1 in vitro clinical test1 after device2 and 7ii7 in subparagraph 7,b71 by inserting or in vitro clinical test after device each place it appears4 7d7 ,debarment1 temporary denial of approval1 and suspension ,section #cjf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cce;a7 is amended by adding at the end the following3 7n7 ,in vitro clinical tests2 mandatory debarment regarding third-,party inspections and reviews 7#a7 ,in general ,if the ,secretary finds that a person has been convicted of a felony under section #cja7;gg71 #cja7;fff77#b71 #cja7;fff77#e71 or #cja7;fff77#h71 the ,secretary shall debar such person from being accredited under section #ehg,p and from carrying out activities under an agreement described in section #hjc7;b74 7#b7 ,debarment period ,the ,secretary shall debar a person under paragraph 7#a7 for the following periods3 7,a7 ,the period of debarment of a person 7other than an individual7 shall not be less than #a year or more than #aj years1 but if an act leading to a subsequent debarment under such paragraph occurs within #aj years after such person has been debarred under such paragraph1 the period of debarment shall be permanent4 7,b7 ,the debarment of an individual shall be permanent4 7#c7 ,termination of debarment2 judicial review2 other matters ,subsections 7c77#c71 7d71 7e71 7i71 7j71 and 7l77#a7 apply with respect to a person 7other than an individual7 or an individual who is debarred under paragraph 7#a7 to the same extent and in the same manner as such subsections apply with respect to a person who is debarred under subsection 7a77#a71 or an individual who is debarred under subsection 7a77#b71 respectively4 4 7e7 ,judicial review ,section #eag7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;g7a77 is amended-- 7#a7 in paragraph 7#h71 by striking or at the end2 7#b7 in paragraph 7#i71 by inserting or after the comma at the end2 and 7#c7 before the matter that follows paragraph 7#i71 by inserting the following3 7#aj7 an order issued pursuant to section #ehg;,b1 #ehg;,d1 #ehg,r1 or #ehg,s1 4 7f7 ,expanded access to unapproved therapies and diagnostics ,section #efa of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb7 is amended-- 7#a7 in subsections 7a7 through 7d7-- 7,a7 by striking or investigational devices each place it appears and inserting 1 investigational devices1 or investigational in vitro clinical tests2 and 7,b7 by striking or investigational device each place it appears 7other than the second such place in paragraph 7#c77;,a77 and inserting 1 investigational device1 or investigational in vitro clinical test2 7#b7 in subsection 7b77#d7 by striking or #ebj7;g7 and inserting 1 #ebj7;g71 or #ehg,r each place it appears2 7#c7 in subsection 7c7-- 7,a7 by amending the subsection heading to read3 ,treatment investigational new drug applications1 treatment investigational device exemptions1 and treatment investigational in vitro clinical test exemptions2 7,b7 in paragraph 7#c77;,a71 by striking or investigational device exemption in effect under section #ebj7;g7 and inserting 1 investigational device exemption in effect under section #ebj7;g71 or investigational in vitro clinical test exemption under section #ehg,r2 7,c7 by striking or treatment investigational device exemption each place it appears and inserting 1 treatment investigational device exemption1 or treatment investigational in vitro clinical test exemption2 and 7,d7 in the matter following paragraph 7#g7 by striking or #ebj7;g7 each place it appears and inserting 1 #ebj7;g7 or #ehg,r2 and 7#d7 by amending subsection 7e7 to read as follows3 7e7 ,definitions ,in this section1 the terms investigational drug1 investigational device1 investigational in vitro clinical test1 treatment investigational new drug application1 treatment investigational device exemption1 and treatment investigational in vitro clinical test exemption shall have the meanings given the terms in regulations prescribed by the ,secretary4 4 7g7 ,optimizing global clinical trials ,section #efi;,a7b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#h;a7b77 is amended by inserting an in vitro clinical test1 as defined in subsection 7ss7 of such section1 before or a biological product4 7h7 ,patient ,participation in ,medical ,product ,discussion ,the heading of subsection 7a7 of section #efi;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#h;c7 is amended by striking ,drugs and ,devices and inserting ,drugs1 ,devices1 and ,in ,vitro ,clinical ,tests4 7i7 ,regulations and hearings ,section #gja7;h77#a77;,c77ii7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cga7;h77#a77;,c77ii77 is amended by inserting and in vitro clinical tests after devices4 7j7 ,factory inspection ,section #gjd of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7 7other than subsection 7g77 is amended-- 7#a7 by striking drugs or devices each place it appears and inserting drugs1 devices1 or in vitro clinical tests2 7#b7 in subsection 7a77#a71 in the third sentence1 by striking or chapter ,,ix and inserting section #ehg,r or chapter ,,ix2 7#c7 in subsection 7a77#b77;,b7-- 7,a7 by inserting or in vitro clinical tests after prescribe or use devices2 and 7,b7 by inserting or in vitro clinical tests after process devices2 7#d7 by inserting in vitro clinical test1 after device1 each place it appears2 7#e7 after making the amendments in paragraphs 7#a7 and 7#b71 by inserting in vitro clinical tests1 after devices1 each place it appears2 7#f7 in subsection 7e71 by inserting 1 or section #ehg,l1 #ehg,m1 or #ehg,r1 after section #eai or #ebj7;g72 and 7#g7 in subsection 7f77#c7-- 7,a7 in subparagraph 7,a71 by striking or at the end2 7,b7 in subparagraph 7,b71 by striking the period at the end and inserting 2 or2 and 7,c7 after subparagraph 7,b71 by inserting the following3 7,c7 is accredited under section #ehg,p4 4 7k7 ,publicity ,section #gje7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cge7;b77 is amended by inserting in vitro clinical tests1 after devices14 7l7 ,presumption ,section #gji of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;a7 is amended by inserting in vitro clinical test1 after device14 7m7 ,imports and exports ,section #hja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7 is amended-- 7#a7 in subsection 7a7-- 7,a7 by inserting in vitro clinical tests1 after devices1 each place it appears2 and 7,b7 by inserting in the case of an in vitro clinical test1 the test does not conform to the applicable requirements of section #ehg;,j1 or after requirements of section #ebj7;f71 or2 7#b7 in subsection 7d77#c7-- 7,a7 in subparagraph 7,a7-- 7i7 in the matter preceding clause 7i71 by inserting and no component of an in vitro clinical test or other article of in vitro clinical test that requires further processing1 after health-related purposes2 7ii7 in clause 7i71 by striking drug or device and inserting drug1 device1 or in vitro clinical test2 and 7iii7 in clause 7i77,i71 by inserting in vitro clinical test1 after device12 and 7,b7 in subparagraph 7,b71 by inserting in vitro clinical test1 after device12 and 7#c7 in subsection 7e77#a71 by inserting in vitro clinical test1 after device14 7n7 ,office of international relations ,section #hjc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #chc7 is amended-- 7#a7 in subsection 7b7-- 7,a7 in the matter preceding paragraph 7#a71 by inserting and in vitro clinical tests after devices2 and 7,b7 in paragraph 7#a71 by inserting quality requirements established under section #ehg;,j2 and at the end2 and 7#b7 in subsection 7c7-- 7,a7 in paragraph 7#b71 by inserting in vitro clinical tests1 after devices12 and 7,b7 in paragraph 7#d71 by inserting or in vitro clinical tests after devices4 7o7 ,recognition of ,foreign ,government ,inspections ,section #hji7;a77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #chd;e7a77#a77 is amended by inserting 1 or section #ehg;,i after #eaj7;h74 7p7 ,food and ,drug ,administration ,section #ajjc7;b77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cic7;b77#b77 is amended-- 7#a7 in subparagraph 7,d71 by striking and at the end2 7#b7 in subparagraph 7,e71 by striking the semicolon at the end and inserting 2 and2 and 7#c7 by adding at the end the following3 7,f7 in vitro clinical tests are analytically and clinically valid2 4 7q7 ,office of ,women's ,health ,section #ajaa7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cii;b7b77 is amended-- 7#a7 in paragraph 7#a71 by inserting in vitro clinical tests1 after devices12 and 7#b7 in paragraph 7#d71 by striking and device manufacturers and inserting device manufacturers1 and in vitro clinical test developers14 7r7 ,countermeasure provisions of the ,,phsa ,title ,,iii of the ,,phsa is amended-- 7#a7 in section #cai;,f-#b7;c77#a77;,b7 7#db ,u4,s4,c4 #bdg;d-#f;b7c77#a77;,b77 is amended-- 7,a7 by striking or device and inserting device2 and 7,b7 by inserting or an in vitro clinical test 7as that term is defined in section #bja7ss7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7ss777 after ,act 7#ba ,u4,s4,c4 #cba7;h7772 7#b7 in section #cai;,f-#a7;a77#b7 7#db ,u4,s4,c4 #bdg;d-#f;a7a77#b771 by inserting an in vitro clinical tests 7as that term is defined in section #bja7ss7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7ss7771 before or device2 and 7#c7 in section #cai;,f-#c7;i77#g7 7#db ,u4,s4,c4 #bdg;d-#f;d7i77#g771 by inserting an in vitro clinical tests 7as that term is defined in section #bja7ss7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7ss7771 before or device4 #e4 ,transition 7a7 ,implementation 7#a7 ,in general ,except as otherwise provided in this section1 the amendments made by this ,act apply beginning on the first day of the fourth fiscal year that begins after the date of enactment of this ,act 7in this section and in subchapter ,j of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by this ,act1 referred to in this section as the effective date of this ,act71 except that the ,secretary of ,health and ,human ,services 7in this section referred to as the ,secretary7 may take the actions described in paragraph 7#b7 as described in such paragraph1 and may take such other actions1 and expend such funds1 as the ,secretary determines necessary to ensure an orderly transition4 7#b7 ,actions ,the ,secretary shall1 prior to the date on which the amendments made by this ,act generally apply pursuant to paragraph 7#a7-- 7,a7 within #b years of the date of enactment of this ,act hold the public meetings described in subchapter ,j of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #c2 7,b7 within #b years of the date of enactment of this ,act promulgate regulations required under sections #ehg,l1 #ehg,m1 #ehg,v1 and #ehg,w2 7,c7 issue final guidance on premarket review requirements under section #ehg;,b1 technology certification review requirements under section #ehg;,d1 and applicability under section #ehg;,a2 and 7,d7 promulgate additional regulations required by such amendments made by this ,act4 7#c7 ,applicability of regulations ,notwithstanding the date on which guidance or regulations are issued under paragraph 7#b71 no guidance or regulations issued pursuant to the amendments made by this ,act shall take effect until the effective date of this ,act1 as described in paragraph 7#a71 except as otherwise provided for transitional tests4 7b7 ,application of authorities to ,in vitro clinical tests until and after effective date of this ,act ,except as provided in subsection 7d71 for any product or test that is an in vitro clinical test as defined in section #bja7ss7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by this ,act1 the following authorities shall apply3 7#a7 ,tests offered prior to enactment ,an in vitro clinical test that meets the criteria for a grandfathered test as set forth in section #ehg;,a7c77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #c1 may continue to be offered for clinical use and shall be subject only to applicable provisions of section #cec of the ,public ,health ,service ,act and section #ehg;,a7a77#d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #c4 7#b7 ,tests offered on or after enactment but before implementation ,before any product or test that is an in vitro clinical test as defined in section #bja7ss7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by this ,act1 is first offered1 sold1 or distributed after the date of enactment of this ,act1 but prior to #ij days before the effective date of this ,act1 such product or test shall be considered a transitional test as described under subsection 7d7 and comply with the applicable device provisions of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq47 and the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bja et seq474 7#c7 ,tests under review beginning on or after the date of enactment of this act but prior to implementation ,for any product or test that is an in vitro clinical test as defined in section #bja7ss7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by this ,act1 for which a submission for marketing authorization under section #eae1 clearance under section #eaj7k71 authorization under section #eac7;f77#b71 approval under section #ebj7m71 or emergency use authorization under section #efd of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e1 #cfj7k71 #cfj;c7f77#b71 #cfj;j7m71 #cfj;bbb-#c7 or approval under the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bja et seq47 is pending on the effective date of this ,act1 the ,secretary may review and take action on such submission after the effective date of this ,act according to the statutory provision under which such submission was submitted4 7c7 ,application of authorities to transitional and grandfathered ,in vitro clinical tests 7#a7 ,definition ,for purposes of this paragraph1 the term transitional in vitro clinical test means an in vitro clinical test1 as defined in section #bja7ss7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by this ,act1 that-- 7,a7 was developed by a clinical laboratory certified by the ,secretary under section #cec of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfc;a7 that meets the requirements for performing high-complexity testing for use only within that certified laboratory or another laboratory within the organization under common ownership2 7,b7 does not have an approval under section #eae1 a clearance under section #eaj7k71 an authorization under section #eac7;f77#b71 an approval under section #ebj7m71 or an emergency use authorization under section #efd of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e1 #cfj7k71 #cfj;c7f77#b71 #cfj;j7m71 #cfj;bbb-#c7 or approval under the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bja et seq472 and 7,c7 is first offered for clinical use during the period beginning on the date of enactment of this ,act and ending on the implementation date of this ,act4 7#b7 ,continued offering ,notwithstanding subsection 7c71 a transitional in vitro clinical test may continue to be offered for clinical use until the effective date of this ,act1 as described in subsection 7b77#a71 except that the ,secretary retains authority to enforce the device provisions of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq47 and the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bja et seq47 for any specific transitional in vitro clinical test1 or any type of transitional in vitro clinical test1 as the ,secretary determines necessary to protect the public from a serious risk to health4 7#c7 ,premarket review or technology certification ,a transitional in vitro clinical test that is the subject of an application for premarket review under section #ehg;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act or technology certification application under section #ehg;,d of such ,act1 as added by this ,act1 that is submitted within #ij days of the effective date of this ,act may continue to be offered1 sold1 or distributed until completion of the ,secretary's review of the premarket application or technology certification application4 7d7 ,conversion 7#a7 ,deemed premarket approval ,any in vitro clinical test 7as defined in section #bja7ss7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by this ,act7 with a premarket approval under section #eae1 a clearance under section #eaj7k71 an authorization under section #eac7;f71 or a licensure under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 is deemed to have an approved application under section #ehg;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by this ,act1 beginning on the later of-- 7,a7 the effective date of this ,act2 or 7,b7 such other date1 not later than #c years after such effective date1 as the person responsible for the device selects4 7#b7 ,deemed investigational use approval ,any in vitro clinical test 7as defined in section #bja7ss7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by this ,act7 that has an approved investigational device exemption under section #ebj7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7g77 is deemed to have an approved investigational use under section #ehg,q of such ,act1 as added by this ,act1 beginning on the effective date of this ,act4 7e7 ,instruments ,an instrument 7as defined in section #ehg of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by this ,act7 that was purchased prior to the date of enactment of this ,act and was not cleared1 authorized1 or approved by the ,food and ,drug ,administration or part of an instrument family that was cleared1 authorized1 or approved by the ,food and ,drug ,administration at the time of purchase may continue to be used by the purchaser to develop and introduce into interstate commerce an in vitro clinical test during the period beginning on the date of enactment of this ,act and ending #e years after such date of enactment4 ,beginning at the end of such period1 any new in vitro clinical test that is developed and introduced into interstate commerce shall be based on an instrument 7as defined in section #ehg7aa7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #c7 that complies with the requirements of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as amended by this ,act4 7f7 ,relation to ,in vitro clinical test provision ,this section applies notwithstanding section #ehg;,a7a77#a77;,c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by this ,act4 #f4 ,emergency use authorization ,section #efd of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c7 is amended-- 7#a7 in paragraphs 7#a7 and 7#d77;,c7 of subsection 7a71 by inserting in vitro clinical test1 before or biological product each place such term appears2 and 7#b7 in subsection 7e77#c7-- 7,a7 in subparagraph 7,b71 by striking and at the end2 7,b7 in subparagraph 7,c71 by striking the period and inserting 2 and2 and 7,c7 by adding at the end the following3 7,d7 quality system requirements 7with respect to in vitro clinical tests7 under section #ehg;,j4 4 #g4 ,antimicrobial susceptibility tests ,section #eaa;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;a-#b7 is amended-- 7#a7 in subsection 7a77#a77;,c7-- 7,a7 by striking or approve under section #eae and inserting approve under section #eae1 or approve1 exempt1 or issue a technology certification order under subchapter ,j2 and 7,b7 by striking testing devices and inserting tests2 7#b7 in subsection 7c77#e71 by striking drug or device each place it appears and inserting drug1 device1 or in vitro clinical test2 7#c7 in subsection 7e7-- 7,a7 in the heading1 by striking testing devices and inserting ,in vitro clinical tests2 7,b7 in paragraph 7#a7-- 7i7 by striking and #eae1 and inserting #eae1 #ehg;,b1 and #ehg;,d2 7ii7 by striking antimicrobial susceptibility testing device and inserting antimicrobial susceptibility in vitro clinical test2 and 7iii7 by striking such device and inserting such test2 7,c7 in paragraph 7#b7-- 7i7 in the heading1 by striking testing devices and inserting in vitro clinical tests2 and 7ii7 by amending subparagraph 7,c7 to read as follows3 7,c7 ,the antimicrobial susceptibility in vitro clinical test meets all other requirements to be approved under section #ehg;,b or exempted from premarket review under section #ehg;,d4 2 and 7,d7 after making the amendments in subparagraphs 7,b77ii71 7,b77iii71 and 7,c77ii71 by striking device each place it appears and inserting in vitro clinical test2 7#d7 in subsection 7f71 by amending paragraph 7#a7 to read as follows3 7#a7 ,the term antimicrobial susceptibility in vitro clinical test means an in vitro clinical test that utilizes susceptibility test interpretive criteria to determine and report the in vitro susceptibility of certain microorganisms to a drug 7or drugs74 2 and 7#e7 in subsection 7g77#b7-- 7,a7 by amending the matter preceding subparagraph 7,a7 to read as follows3 7#b7 with respect to clearing under section #eaj7k71 classifying under section #eac7;f77#b71 approving under section #eae or section #ehg;,b1 or exempting from approval requirements under section #ehg;,d-- 2 and 7,b7 in subparagraph 7,a7-- 7i7 by striking device and inserting in vitro clinical test2 and 7ii7 by striking antimicrobial susceptibility testing device and inserting antimicrobial susceptibility in vitro clinical test4 #h4 ,combination products 7a7 ,in general ,section #ejc7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;g77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 in subparagraph 7,a7-- 7i7 by inserting 7except for a combination product constituted of a device and an in vitro clinical test7 after agency center12 and 7ii7 by inserting in vitro clinical test1 before or biological product2 and 7,b7 in subparagraph 7,d7-- 7i7 in the matter preceding clause 7i71 by striking 4 ,if the ,secretary determines and inserting 1 except for a combination product constituted of a device and an in vitro clinical test4 ,for other combination products1 if the ,secretary determines2 and 7ii7 in clause 7ii7-- 7,i7 by inserting or in vitro clinical test after device2 and 7,,ii7 by inserting and in vitro clinical tests before shall2 7#b7 in paragraph 7#c71 by striking safety and effectiveness or substantial equivalence and inserting safety and effectiveness1 substantial equivalence1 or analytical validity and clinical validity before for the approved constituent part2 7#c7 in paragraph 7#d7-- 7,a7 in subparagraph 7,a71 by striking or #eac7;f77#b7 7submitted in accordance with paragraph 7#e77 and inserting #eac7;f77#b7 7submitted in accordance with paragraph 7#e771 #ehg;,b1 or an exempt test under section #ehg;,a1 as applicable2 and 7,b7 in subparagraph 7,b71 by inserting or #ehg;,b after section #eae2 7#d7 in paragraph 7#e77;,a71 by striking or #eaj7k7 and inserting 1 #eaj7k71 or #ehg;,b2 7#e7 in paragraph 7#g71 by striking or substantial equivalence and inserting 1 substantial equivalence1 or analytical validity and clinical validity2 7#f7 in paragraph 7#h71 by adding at the end the following3 7,i7 ,this paragraph shall not apply to a combination product constituted of a device and an in vitro clinical test4 2 and 7#g7 in paragraph 7#i7-- 7,a7 in subparagraph 7,c77i71 by striking or #ebj7;g7 and inserting #ebj7;g71 or #ehg;,b2 and 7,b7 in subparagraph 7,d71 by striking or #ebj and inserting #ebj1 or #ehg;,b4 7b7 ,classification of products ,section #efc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#b7 is amended by adding at the end the following3 7d7 ,exemption ,this section shall not apply to a combination product constituted of a device and an in vitro clinical test4 4 #i4 ,resources 7a7 ,findings ,congress finds that the fees authorized by this section will be dedicated to meeting the goals identified in the letters from the ,secretary of ,health and ,human ,services to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 as set forth in the ,congressional ,record4 7b7 ,establishment of user fee program 7#a7 ,development of user fees for in vitro clinical tests 7,a7 ,in general ,beginning not later than ,october #a1 #bjbj1 the ,secretary of ,health and ,human ,services 7in this section referred to as the ,secretary7 shall develop recommendations to present to ,congress with respect to the goals1 and plans for meeting the goals1 for the process of the review of in vitro clinical test applications submitted under subchapter ,j of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by this ,act1 for the first #e fiscal years after fiscal year #bjba4 ,in developing such recommendations1 the ,secretary shall consult with-- 7i7 the ,committee on ,energy and ,commerce of the ,house of ,representatives2 7ii7 the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate2 7iii7 scientific and academic experts2 7iv7 health care professionals2 7v7 representatives of patient and consumer advocacy groups2 and 7vi7 the regulated industry4 7,b7 ,prior public input ,prior to beginning negotiations with the regulated industry on the authorization of such subchapter ,j1 the ,secretary shall-- 7i7 publish a notice in the ,federal ,register requesting public input on the authorization of user fees2 7ii7 hold a public meeting at which the public may present its views on the authorization1 including specific suggestions for the recommendations submitted under subparagraph 7,e72 7iii7 provide a period of #cj days after the public meeting to obtain written comments from the public suggesting changes to such subchapter ,j2 and 7iv7 publish any comments received under clause 7iii7 on the internet website of the ,food and ,drug ,administration4 7,c7 ,periodic consultation ,not less frequently than once every month during negotiations with the regulated industry1 the ,secretary shall hold discussions with representatives of patient and consumer advocacy groups to continue discussions of the authorization under such subchapter ,j and to solicit suggestions to be included in the recommendations transmitted to ,congress under subparagraph 7,e74 7,d7 ,public review of recommendations ,after negotiations with the regulated industry1 the ,secretary shall-- 7i7 present the recommendations developed under subparagraph 7,a7 to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives2 7ii7 publish such recommendations in the ,federal ,register2 7iii7 provide for a period of #cj days for the public to provide written comments on such recommendations2 7iv7 hold a meeting at which the public may present its views on such recommendations2 and 7v7 after consideration of such public views and comments1 revise such recommendations as necessary4 7,e7 ,transmittal of recommendations 7i7 ,in general ,not later than ,june #a1 #bjba1 the ,secretary shall transmit to ,congress the revised recommendations under subparagraph 7,a71 a summary of the views and comments received under such subparagraph1 and any changes made to the recommendations in response to such views and comments4 7ii7 ,recommendation requirements ,the recommendations transmitted under this subparagraph shall-- 7,i7 include the number of full-time equivalent employees per fiscal year that are agreed to be hired to carry out the goals included in such recommendations for each year of the #e-year period2 7,,ii7 provide that the amount of operating reserve balance in the user fee program established under this section is not more than the equivalent of #aj weeks of operating reserve2 7,,iii7 require the development of a strategic plan for any surplus within the operating reserve account above the #aj-week operating reserve within #b years of the establishment of the program2 7,,iv7 include an operating reserve adjustment such that1 if the ,secretary has an operating reserve balance in excess of #aj weeks of such operating reserves1 the ,secretary shall decrease such fee revenue and fees to provide for not more than #aj weeks of such operating reserves2 7,v7 if an adjustment is made as described in subclause 7,,iv71 provide the rationale for the amount of the decrease in fee revenue and fees shall be contained in the ,federal ,register2 and 7,,vi7 provide that the fees assessed and collected for the full-time equivalent employees at the ,center for ,devices and ,radiological ,health1 with respect to which the majority of time reporting data indicates are dedicated to the review of in vitro clinical tests1 are not supported by the funds authorized to be collected and assessed under section #gch of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j74 7,f7 ,publication of recommendations ,the ,secretary shall publish on the internet website of the ,food and ,drug ,administration the revised recommendations under subparagraph 7,a71 a summary of the views and comments received under subparagraphs 7,b7 through 7,d71 and any changes made to the recommendations originally proposed by the ,secretary in response to such views and comments4 7,g7 ,minutes of negotiation meetings 7i7 ,public availability ,before transmitting the recommendations developed under subparagraphs 7,a7 through 7,f7 to ,congress1 the ,secretary shall make publicly available1 on the internet website of the ,food and ,drug ,administration1 minutes of all negotiation meetings conducted under this subsection between the ,food and ,drug ,administration and the regulated industry4 7ii7 ,content ,the minutes described under clause 7i7 shall summarize any substantive proposal made by any party to the negotiations1 any significant controversies or differences of opinion during the negotiations1 and the resolution of any such controversy or difference of opinion4 7#b7 ,establishment of user fee program ,effective on ,october #a1 #bjba1 provided that the ,secretary transmits the recommendations under paragraph 7#a77;,e71 the ,secretary is authorized to collect user fees relating to the submission of in vitro clinical test applications submitted under subchapter ,j of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by this ,act4 ,fees under such program shall be assessed and collected only if the requirements under paragraph 7#d7 are met4 7#c7 ,audit 7,a7 ,in general ,on the date that is #b years after first receiving a user fee applicable to submission of an in vitro clinical test application submitted under subchapter ,j of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by this ,act1 and on a biennial basis thereafter until ,october #a1 #bjbg1 the ,secretary shall perform an audit of the costs of reviewing such applications under such subchapter ,j4 ,such an audit shall compare the costs of reviewing such applications under such subchapter ,j to the amount of the user fee applicable to such applications4 7,b7 ,alteration of user fee ,if the audit performed under subparagraph 7,a7 indicates that the user fees applicable to applications submitted under such subchapter ,j exceed #cj percent of the costs of reviewing such applications1 the ,secretary shall alter the user fees applicable to applications submitted under such subchapter ,j such that the user fees do not exceed such percentage4 7,c7 ,accounting standards ,the ,secretary shall perform an audit under subparagraph 7,a7 in conformance with the accounting principles1 standards1 and requirements prescribed by the ,comptroller ,general of the ,united ,states under section #ceaa of title #ca1 ,united ,states ,code1 to ensure the validity of any potential variability4 7#d7 ,conditions ,the user fee program described in this subsection shall take effect only if the ,food and ,drug ,administration issues draft guidance related to the review requirements for in vitro diagnostic tests that would be subject to premarket review under section #ehg;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #c1 the review requirements for test categories eligible for technology certification under section #ehg;,d of such ,act1 as added by section #c1 and the parameters for the test categories that would be exempt from any review under subchapter ,j of chapter ,v of such ,act4 7#e7 ,user fee program definitions and resource requirements 7,a7 ,in general ,the term process for the review of in vitro clinical test applications means the following activities of the ,secretary with respect to the review of premarket applications under section #ehg;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7as added by section #c71 technology certification applications under section #ehg;,d of such ,act 7as added by section #c71 and supplements for such applications3 7i7 ,the activities necessary for the review of premarket applications1 premarket reports1 and supplements to such applications4 7ii7 ,the issuance of action letters that allow the marketing of in vitro clinical tests or which set forth in detail the specific deficiencies in such applications1 reports1 supplements1 or submissions and1 where appropriate1 the actions necessary to place them in condition for approval4 7iii7 ,the inspection of manufacturing establishments and other facilities undertaken as part of the ,secretary's review of pending premarket applications1 technology certifications1 and supplements4 7iv7 ,monitoring of research conducted in connection with the review of such applications1 supplements1 and submissions4 7v7 ,review of in vitro clinical test applications subject to section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb71 investigational new drug applications under section #eje7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;i771 or investigational test exemptions under section #ehg;,a7m7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7as added by section #c71 and activities conducted in anticipation of the submission of such applications under section #eje7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or investigational use under section #ehg,r of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7as added by section #c74 7vi7 ,the development of guidance1 policy documents1 or regulations to improve the process for the review of premarket applications1 technology certification applications1 and supplements4 7vii7 ,the development of voluntary test methods1 consensus standards1 or mandatory performance standards in connection with the review of such applications1 supplements1 or submissions and related activities4 7viii7 ,the provision of technical assistance to in vitro clinical test developers in connection with the submission of such applications1 reports1 supplements1 or submissions4 7ix7 ,any activity undertaken in connection with the initial classification or reclassification of an in vitro clinical test in connection with any requirement for approval of an in vitro clinical test4 7x7 ,evaluation of postmarket studies required as a condition of an approval of a premarket application of an in vitro clinical test4 7xi7 ,compiling1 developing1 and reviewing information on relevant in vitro clinical tests to identify issues with the applicable standard for premarket applications1 technology certification applications1 and supplements4 7,b7 ,resource requirements ,fees collected and assessed under this section shall be used for the process for the review of in vitro clinical test applications1 as described in subparagraph 7,a71 and shall-- 7i7 be subject to the limitation under section #gch7;g77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7g77#c771 in the same manner that fees collected and assessed under section #gcg7i77;,c7 of such ,act 7#ba ,u4,s4,c4 #cgi;i7#i77;,c77 are subject to such limitation2 7ii7 include travel expenses for officers and employees of the ,food and ,drug ,administration only if the ,secretary determines that such travel is directly related to an activity described in subparagraph 7,a72 and 7iii7 not be allocated to purposes described under section #gbb7;a7 of the ,consolidated ,appropriations ,act1 #bjah 7,public ,law #aae-ada74 7c7 ,reports 7#a7 ,performance report 7,a7 ,in general 7i7 ,general requirements ,beginning with fiscal year #bjba1 for each fiscal year for which fees are collected under this section1 the ,secretary shall prepare and submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives annual reports concerning the progress of the ,food and ,drug ,administration in achieving the goals identified in the recommendations transmitted to ,congress by the ,secretary pursuant to subsection 7b77#a77;,e7 during such fiscal year and the future plans of the ,food and ,drug ,administration for meeting the goals4 7ii7 ,additional information ,beginning with fiscal year #bjba1 the annual report under this subparagraph shall include the progress of the ,food and ,drug ,administration in achieving the goals1 and future plans for meeting the goals1 including-- 7,i7 the number of premarket applications filed under section #ehg;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act during the applicable fiscal year2 7,,ii7 the number of technology certification applications submitted under section #ehg;,d of the ,federal ,food1 ,drug1 and ,cosmetic ,act during the applicable fiscal year for each review division2 and 7,,iii7 the number of breakthrough designations under section #ehg;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act during the applicable fiscal year4 7iii7 ,real-time reporting 7,i7 ,in general ,not later than #cj calendar days after the end of the second quarter of fiscal year #bjba1 and not later than #cj calendar days after the end of each quarter of each fiscal year thereafter1 the ,secretary shall post the data described in subclause 7,,ii7 on the internet website of the ,food and ,drug ,administration for such quarter and on a cumulative basis for such fiscal year1 and may remove duplicative data from the annual report under this subparagraph4 7,,ii7 ,data ,the ,secretary shall post the following data in accordance with subclause 7,i73 7aa7 ,the number and titles of draft and final guidance on topics related to the process for the review of in vitro clinical tests1 and whether such guidances were issued as required by statute or pursuant to the recommendations transmitted to ,congress by the ,secretary pursuant to subsection 7b77#a77;,e74 7bb7 ,the number and titles of public meetings held on topics related to the process for the review of in vitro clinical tests1 and if such meetings were required by statute or pursuant to the recommendations transmitted to ,congress by the ,secretary pursuant to subsection 7b77#a77;,e74 7iv7 ,rationale for ,,ivct user fee program changes ,beginning with fiscal year #bjbb1 the ,secretary shall include in the annual performance report under paragraph 7#a7-- 7,i7 data1 analysis1 and discussion of the changes in the number of full-time equivalents hired as agreed upon in the recommendations transmitted to ,congress by the ,secretary pursuant to subsection 7b77#a77;,e7 and the number of full-time equivalents funded by budget authority at the ,food and ,drug ,administration by each division within the ,center for ,devices and ,radiological ,health1 the ,center for ,biologics ,evaluation and ,research1 the ,office of ,regulatory ,affairs1 and the ,office of the ,commissioner2 7,,ii7 data1 analysis1 and discussion of the changes in the fee revenue amounts and costs for the process for the review of in vitro clinical tests1 including identifying drivers of such changes2 and 7,,iii7 for each of the ,center for ,devices and ,radiological ,health1 the ,center for ,biologics ,evaluation and ,research1 the ,office of ,regulatory ,affairs1 and the ,office of the ,commissioner1 the number of employees for whom time reporting is required and the number of employees for whom time reporting is not required4 7v7 ,analysis ,for each fiscal year1 the ,secretary shall include in the report under clause 7i7 an analysis of the following3 7,i7 ,the difference between the aggregate number of premarket applications filed under section #ehg;,b or section #ehg;,d of the ,federal ,food1 ,drug1 and ,cosmetic ,act and the aggregate number of major deficiency letters1 not approvable letters1 and denials for such applications issued by the agency1 accounting for-- 7aa7 the number of applications filed under each of sections #ehg;,b and #ehg;,d of the ,federal ,food1 ,drug1 and ,cosmetic ,act during one fiscal year for which a decision is not scheduled to be made until the following fiscal year2 and 7bb7 the aggregate number of applications under each of sections #ehg;,b and #ehg;,d of the ,federal ,food1 ,drug1 and ,cosmetic ,act for each fiscal year that did not meet the goals as identified by the recommendations transmitted to ,congress by the ,secretary pursuant to subsection 7b77#a77;,e74 7,,ii7 ,relevant data to determine whether the ,center for ,devices and ,radiological ,health has met performance enhancement goals identified by the recommendations transmitted to ,congress by the ,secretary pursuant to subsection 7b77#a77;,e74 7,,iii7 ,the most common causes and trends for external or other circumstances affecting the ability of the ,food and ,drug ,administration to meet review time and performance enhancement goals identified by the recommendations transmitted to ,congress by the ,secretary pursuant to subsection 7b77#a77;,e74 7,b7 ,publication ,with regard to information to be reported by the ,food and ,drug ,administration to industry on a quarterly and annual basis pursuant to recommendations transmitted to ,congress by the ,secretary pursuant to subsection 7b77#a77;,e71 the ,secretary shall make such information publicly available on the internet website of the ,food and ,drug ,administration not later than #fj days after the end of each quarter or #abj days after the end of each fiscal year1 respectively1 to which such information applies4 7,c7 ,updates ,the ,secretary shall include in each report under subparagraph 7,a7 information on all previous cohorts for which the ,secretary has not given a complete response on all in vitro clinical test premarket applications and technology certification orders and supplements1 premarket1 and technology certification notifications in the cohort4 7#b7 ,corrective action report ,beginning with fiscal year #bjbb1 for each fiscal year for which fees are collected under this section1 the ,secretary shall prepare and submit a corrective action report to the ,committee on ,health1 ,education1 ,labor1 and ,pensions and the ,committee on ,appropriations of the ,senate and the ,committee on ,energy and ,commerce and the ,committee on ,appropriations of the ,house of ,representatives4 ,the report shall include the following information1 as applicable3 7,a7 ,goals met ,for each fiscal year1 if the ,secretary determines1 based on the analysis under paragraph 7#a77;,a77v71 that each of the goals identified by the recommendations transmitted to ,congress by the ,secretary pursuant to subsection 7b77#a77;,e7 for the applicable fiscal year have been met1 the corrective action report shall include recommendations on ways in which the ,secretary can improve and streamline the in vitro clinical test premarket application and technology certification review process4 7,b7 ,goals missed ,for each of the goals identified by the letters described in recommendations transmitted to ,congress by the ,secretary pursuant to subsection 7b77#a77;,e7 for the applicable fiscal year that the ,secretary determines to not have been met1 the corrective action report shall include-- 7i7 a justification for such determination2 7ii7 a description of the types of circumstances1 in the aggregate1 under which applications or reports submitted under sections #ehg;,b and #ehg;,d of the ,federal ,food1 ,drug1 and ,cosmetic ,act missed the review goal times but were approved during the first cycle review1 as applicable2 7iii7 a summary and any trends with regard to the circumstances for which a review goal was missed2 and 7iv7 the performance enhancement goals that were not achieved during the previous fiscal year and a description of efforts the ,food and ,drug ,administration has put in place for the fiscal year in which the report is submitted to improve the ability of such agency to meet each such goal for the such fiscal year4 7#c7 ,fiscal report ,for fiscal years #bjba and annually thereafter1 not later than #abj days after the end of each fiscal year during which fees are collected under this subpart1 the ,secretary shall prepare and submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 a report on the implementation of the authority for such fees during such fiscal year and the use1 by the ,food and ,drug ,administration1 of the fees collected during such fiscal year for which the report is made4 7,a7 ,contents ,such report shall include expenditures delineated by budget authority and user fee dollars related to administrative expenses and information technology infrastructure contracts and expenditures4 7,b7 ,operating reserve ,such report shall provide the amount of operating reserve balance available each year1 and any planned allocations or obligations of such balance that is above #aj weeks of operating reserve for the program4 7#d7 ,public availability ,the ,secretary shall make the reports required under paragraphs 7#a7 through 7#c7 available to the public on the internet website of the ,food and ,drug ,administration4 7#e7 ,enhanced communication 7,a7 ,communications with ,congress ,each fiscal year1 as applicable and requested1 representatives from the ,centers with expertise in the review of in vitro clinical tests shall meet with representatives from the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives to report on the contents described in the reports under this section4 7,b7 ,participation in congressional hearing ,each fiscal year1 as applicable and requested1 representatives from the ,food and ,drug ,administration shall participate in a public hearing before the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 to report on the contents described in the reports under this section4 ,such hearing shall occur not later than #abj days after the end of each fiscal year for which fees are collected under this section4