,,ii #aadth ,,congress #ast ,session ,s4 #bahg ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,october #ba1 #bjae ,mr4 ,donnelly 7for himself and ,mr4 ,gardner7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to establish a third-party quality system assessment program4 #a4 ,short title ,this ,act may be cited as the ,,fda ,regulatory ,efficiency ,act4 #b4 ,third-party quality system assessment 7a7 ,establishment of third-,party quality system assessment program ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended by inserting after section #ebd;,a 7#ba ,u4,s4,c4 #cfjn-#a7 the following3 #ebd;,b4 ,third-party quality system assessment 7a7 ,accreditation and assessment 7#a7 ,in general2 certification of device quality system ,the ,secretary shall1 in accordance with this section1 establish a third-party quality system assessment program-- 7,a7 to accredit persons to assess whether a requestor's quality system1 including its design controls1 can reasonably assure the safety and effectiveness of in-scope devices subject to device-related changes2 7,b7 under which accredited persons shall 7as applicable7 certify that a requestor's quality system meets the criteria included in the guidance issued under paragraph 7#e7 with respect to the in-scope devices at issue2 and 7,c7 under which the ,secretary shall rely on such certifications for purposes of determining the safety and effectiveness 7or as applicable1 substantial equivalence7 of in-scope devices subject to the device-related changes involved1 in lieu of compliance with the following submission requirements3 7i7 ,a premarket notification4 7ii7 ,a #cj-;day notice4 7iii7 ,a ,special ,,pma supplement4 7#b7 ,definitions ,for purposes of this section-- 7,a7 the term device-related changes means changes made by a requestor with respect to in-scope devices1 which are-- 7i7 changes to a device found to be substantially equivalent under subsections 7f77#a7 and 7i7 of section #eac to a predicate device1 that-- 7,i7 would otherwise be subject to a premarket notification2 and 7,,ii7 do not alter-- 7aa7 the intended use of the changed device2 or 7bb7 the fundamental scientific technology of such device2 7ii7 manufacturing changes subject to a #cj-;day notice2 7iii7 changes that qualify for a ,special ,,pma ,supplement2 and 7iv7 such other changes relating to the devices or the device manufacturing process as the ,secretary determines appropriate2 7,b7 the term in-scope device means a device within the scope of devices agreed to by the requestor and the accredited person for purposes of a request for certification under this section2 7,c7 the term premarket notification means a premarket notification under section #eaj7k72 7,d7 the term quality system means the methods used in1 and the facilities and controls used for1 the design1 manufacture1 packaging1 labeling1 storage1 installation1 and servicing of devices1 as described in section #ebj7;f72 7,e7 the term requestor means a device manufacturer that is seeking certification under this section of a quality system used by such manufacturer2 7,f7 the term ,special ,,pma means a ,,pma supplement under section #had4ci7;d7 of title #ba1 ,code of ,federal ,regulations 7or any successor regulations72 and 7,g7 the term #cj-;day notice means a notice described in section #eae7;d77#f74 7#c7 ,accreditation process2 accreditation renewal ,except as inconsistent with this section1 the process and qualifications for accreditation of persons and renewal of such accreditation under section #gjd7;g7 shall apply with respect to accreditation of persons and renewal of such accreditation under this section4 7#d7 ,use of accredited parties to conduct assessments 7,a7 ,initiation of assessment services 7i7 ,date assessments authorized ,beginning after the date on which the final guidance is issued under paragraph 7#e71 an accredited person may conduct an assessment under this section4 7ii7 ,initiation of assessments ,use of one or more accredited persons to assess a requestor's quality system under this section with respect to in-scope devices shall be at the initiation of the person who registers and lists the devices at issue under section #eaj4 7,b7 ,compensation ,compensation for such accredited persons shall-- 7i7 be determined by agreement between the accredited person and the person who engages the services of the accredited person2 and 7ii7 be paid by the person who engages such services4 7,c7 ,accredited person selection ,each person who chooses to use an accredited person to assess a requestor's quality system1 as described in this section1 shall select the accredited person from a list of such persons published by the ,secretary in accordance with section #gjd7;g77#d74 7#e7 ,guidance2 criteria for certification 7,a7 ,in general ,the criteria for certification of a quality system under this section shall be as specified by the ,secretary in guidance issued under this paragraph4 7,b7 ,contents2 criteria ,the guidance under this paragraph shall include specification of-- 7i7 evaluative criteria to be used by an accredited person to assess and1 as applicable1 certify a requestor's quality system under this section with respect to in-scope devices2 and 7ii7 criteria for accredited persons to apply for a waiver of1 and exemptions from1 the criteria under clause 7i74 7,c7 ,timeframe for issuing guidance ,the ,secretary shall issue under this paragraph-- 7i7 draft guidance not later than #ab months after the enactment of the ,,fda ,regulatory ,efficiency ,act2 and 7ii7 final guidance not later than #ab months after issuance of the draft guidance under clause 7i74 7b7 ,use of third-,party assessment 7#a7 ,assessment summary2 certification 7,a7 ,submission of assessment to secretary ,an accredited person who assesses a requestor's quality system under subsection 7a7 shall submit to the ,secretary a summary of the assessment-- 7i7 within #cj days of the assessment2 and 7ii7 which shall include 7as applicable7-- 7,i7 the accredited person's certification that the requestor has satisfied the criteria specified in the guidance issued under subsection 7a77#e7 for quality system certification with respect to the in-scope devices at issue2 and 7,,ii7 any waivers or exemptions from such criteria applied by the accredited person4 7,b7 ,treatment of assessments ,subject to action by the ,secretary under subparagraph 7,c71 with respect to assessments which include a certification under this section-- 7i7 the ,secretary's review of the assessment summary shall be deemed complete on the day that is #cj days after the date on which the ,secretary receives the summary under subparagraph 7,a72 and 7ii7 the assessment summary and certification of the quality system of a requestor shall be deemed accepted by the ,secretary on such #cjth day4 7,c7 ,actions by secretary 7i7 ,in general ,within #cj days of receiving an assessment summary and certification under subparagraph 7,a71 the ,secretary may1 by written notice to the accredited person submitting such assessment certification1 deem any such certification to be provisional beyond such #cj-;day period1 suspended pending further review by the ,secretary1 or otherwise qualified or cancelled1 based on the ,secretary's determination that 7as applicable7-- 7,i7 additional information is needed to support such certification2 7,,ii7 such assessment or certification is unwarranted2 or 7,,iii7 such action with regard to the certification is otherwise justified according to such factors and criteria as the ,secretary finds appropriate4 7ii7 ,acceptance of certification ,if following action by the ,secretary under clause 7i7 with respect to a certification1 the ,secretary determines that such certification is acceptable1 the ,secretary shall issue written notice to the applicable accredited person indicating such acceptance4 7#b7 ,notifications to ,secretary by certified requestors or accredited persons for program evaluation purposes 7,a7 ,annual summary report for device-related changes otherwise subject to premarket notification ,a requestor whose quality system is certified under this section that effectuates device-related changes with respect to in-scope devices1 without prior submission of a premarket notification1 shall ensure that an annual summary report is submitted to the ,secretary by the accredited person which-- 7i7 describes the changes made to the in-scope device2 and 7ii7 indicates the effective dates of such changes4 7,b7 ,periodic notification for manufacturing changes otherwise subject to #cj-;day notice ,a requestor whose quality system is certified under this section that effectuates device-related changes with respect to in-scope devices1 without prior submission of a #cj-;day notice1 shall provide notification to the ,secretary of such changes in the requestor's next periodic report under section #had4hd7;b7 of title #ba1 ,code of ,federal ,regulations 7or any successor regulation74 ,such notification shall-- 7i7 describe the changes made2 and 7ii7 indicate the effective dates of such changes4 7,c7 ,periodic notification for device-related changes otherwise subject to special pma supplement ,a requestor whose quality system is certified under this section that effectuates device-related changes with respect to in-scope devices1 without prior submission of a ,special ,,pma ,supplement1 shall provide notification to the ,secretary of such changes in the requestor's next periodic report under section #had4hd7;b7 of title #ba1 ,code of ,federal ,regulations 7or any successor regulation74 ,such notification shall-- 7i7 describe the changes made1 including a full explanation of the basis for the changes2 and 7ii7 indicate the effective dates of such changes4 7,d7 ,use of notifications for program evaluation purposes ,information submitted to the ,secretary under subparagraphs 7,a7 through 7,c7 shall be used by the ,secretary for purposes of the program evaluation under subsection 7d74 7c7 ,duration and effect of certification ,a certification under this section-- 7#a7 shall remain in effect for a period of #b years from the date such certification is accepted by the ,secretary1 subject to paragraph 7#f72 7#b7 may be renewed through the process described in subsection 7a77#c72 7#c7 shall continue to apply with respect to device-related changes made during such #b-year period1 provided the certification remains in effect1 irrespective of whether such certification is renewed after such #b-year period2 7#d7 shall have no effect on the need to comply with applicable submission requirements specified in subsection 7a77#a77;,c7 with respect to any change pertaining to in-scope devices which is not a device-related change under subsection 7a77#b72 7#e7 shall have no effect on the authority of the ,secretary to conduct an inspection or otherwise determine whether the requestor has complied with the applicable requirements of this ,act2 and 7#f7 may be revoked by the ,secretary upon a determination that the requestor's quality system no longer meets the criteria specified in the guidance issued under subsection 7a77#e7 with respect to the in-scope devices at issue4 7d7 ,notice of revocation ,the ,secretary shall provide written notification to the requestor of a revocation pursuant to subsection 7c77#f7 not later than #aj business days after the determination described in such subsection4 ,upon receipt of the written notification1 the requestor shall satisfy the applicable submission requirements specified in subsection 7a77#a77;,c7 for any device-related changes effectuated after the date of such determination4 ,after such revocation1 such requestor is eligible to seek re-certification under this section of its quality system4 7e7 ,program evaluation2 sunset 7#a7 ,program evaluation and report 7,a7 ,evaluation ,the ,secretary shall complete an evaluation of the third-party quality system assessment program under this section no later than ,january #ca1 #bjba1 based on-- 7i7 analysis of information from a representative group of device manufacturers obtained from notifications provided by certified requestors or accredited persons under subsection 7b77#b72 and 7ii7 such other available information and data as the ,secretary determines appropriate4 7,b7 ,report ,no later than #a year after completing the evaluation under subparagraph 7,a71 the ,secretary shall issue a report of the evaluation's findings on the website of the ,food and ,drug ,administration1 which shall include the ,secretary's recommendations with respect to continuation and as applicable expansion of the program under this section to encompass-- 7i7 device submissions beyond those identified in subsection 7a77#a77;,c72 and 7ii7 device changes beyond those described in subsection 7a77#b77;,a74 7#b7 ,sunset ,this section shall cease to be effective ,october #a1 #bjbb4 7f7 ,rule of construction ,nothing in this section shall be construed to limit the authority of the ,secretary to request and review the complete assessment of a certified requestor under this section on a for-cause basis4 4 7b7 ,conforming amendments 7#a7 ,requirements for premarket approval supplements ,section #eae7;d77#f77;,a77i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e7d77#e77;,a77i77 is amended by inserting subject to section #ebd;,b1 after that affects safety or effectiveness14 7#b7 ,requirements for #cj-;day notice ,section #eae7;d77#f77;,a77ii7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e7d77#e77;,a77ii77 is amended by inserting subject to section #ebd;,b1 after the date on which the ,secretary receives the notice14 7#c7 ,requirements for premarket notification2 technical correction to reference to section #eaj7k7 ,section #eaj7l7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7l77 is amended by striking of this subsection under subsection 7m7 and inserting of subsection 7k7 under subsection 7m7 or section #ebd;,b4 7#d7 ,misbranded devices ,section #ejb7t7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7t77 is amended by inserting or #ebd;,b after section #eai4