,i #aah? ,,congress #a/ ,session ,h4 ,r4 #bcfi ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,m>* #bi1 #bjbc,mr4 ,buc%on 7= himself & ,ms4 ,de,gette7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce1 & 9 addition to ! ,committee on ,ways & ,means1 = a p]iod to be subsequ5tly det]m9$ by ! ,speak]1 9 ea* case = consid]ation ( su* provisions z fall )9 ! jurisdiction ( ! committee conc]n$ ,a ,,bill ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act ) respect to 9 vitro cl9ical te/s1 & = o!r purposes4 #a4 ,%ort title 7a7 ,%ort title ,?is ,act may be cit$ z ! ,v]ify+ ,accurate ,lead+-edge ,,ivct ,developm5t ,act ( #bjbc or ! ,,valid ,act ( #bjbc4 #b4 ,def9itions 7a7 ,9 g5]al ,section #bja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7 is am5d$-- 7#a7 by add+ at ! end ! foll[+3 7ss7 7#a7 ,! t]m 9 vitro cl9ical te/ means an article specifi$ 9 subp>agraph 7#b7 t is int5d$ to be us$ 9 ! collection1 prep>ation1 analysis1 or 9 vitro cl9ical exam9ation ( specim5s tak5 or d]iv$ f ! human body = ! purpose (-- 7,a7 id5tify+ or diagnos+ a disease or condition2 7,b7 provid+ in=mation = diagnos+1 scre5+1 measur+1 detect+1 pr$ict+1 prognos+1 analyz+1 or monitor+ a disease or condition1 includ+ by mak+ a det]m9ation ( an individual's /ate ( heal?2 or 7,c7 select+1 monitor+1 or in=m+ !rapy or treatm5t = a disease or condition4 7#b7 ,an article specifi$ 9 ?is subp>agraph is-- 7,a7 a te/ kit2 7,b7 a te/ sy/em2 7,c7 a te/ protocol or laboratory te/ protocol2 7,d7 an in/rum5t 7z def9$ 9 section #ehg7aa772 7,e7 a specim5 receptacle 7z def9$ 9 section #ehg7ag772 7,f7 s(tw>e1 exclud+ s(tw>e t is exclud$ by section #ebj7o7 f ! def9ition ( a device "u section #bja7;h71 t-- 7i7 is a compon5t or "p ( ano!r 9 vitro cl9ical te/ or analyzes1 processes1 or int]prets a signal or patt]n f ano!r 9 vitro cl9ical te/2 & 7ii7 does n analyze1 process1 or int]pret a signal1 patt]n1 or m$ical image f a device2 & 7,g7 subject to subp>agraph 7#c71 a compon5t or "p ( a te/ kit1 a te/ sy/em1 a te/ protocol or laboratory te/ protocol1 an in/rum5t1 a specim5 receptacle1 or s(tw>e describ$ 9 subp>agraph 7,f71 :e!r alone or 9 comb9ation1 includ+ reag5ts1 calibrators1 & controls4 7#c7 ,not)/&+ subp>agraph 7#b77;,g71 an article int5d$ to be us$ z a compon5t or "p ( an 9 vitro cl9ical te/ describ$ 9 subp>agraph 7#a7 is exclud$ f ! def9ition 9 subp>agraph 7#a7 if ! article consi/s ( any ( ! foll[+3 7,a7 ,blood1 blood compon5ts1 or human cells or tissues1 f ! "t ( acquisition1 donation1 or recov]y ( su* article1 includ+ det]m9ation ( donor eligibility1 z applicable1 until su* "t z ! article is releas$ z a compon5t or "p ( an 9 vitro cl9ical te/ by ! e/abli%m5t t collect$ su* article4 7,b7 ,an article us$ = invasive sampl+1 a ne$le1 or a lancet1 except to ! ext5t su* article1 ne$le1 or lancet is an integral compon5t ( an article = hold+1 /or+1 or transport+ a specim54 7,c7 ,g5]al purpose laboratory equipm5t4 2 7#b7 by add+ at ! end ( p>agraph 7g7 ! foll[+3 7#c7 ,! t]m drug does n include an 9 vitro cl9ical te/4 2 & 7#c7 9 p>agraph 7h77#a71 9 ! matt] foll[+ clause 7,c71 by /rik+ section #ebj7o7 & ins]t+ section #ebj7o7 or an 9 vitro cl9ical te/4 7b7 ,exclusion f def9ition ( biological product ,section #cea7;i77#a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;i77#a77 is am5d$-- 7#a7 by /rik+ 7#a7 ,! t]m biological product means & ins]t+ 7#a77;,a7 ,! t]m biological product means2 & 7#b7 by add+ at ! end ! foll[+3 7,b7 ,! t]m biological product does n include an 9 vitro cl9ical te/ z def9$ 9 section #bja7ss7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act4 4 7c7 ,9 vitro cl9ical te/ def9ition ,9 ?is ,act1 ! t]m 9 vitro cl9ical te/ has ! mean+ giv5 su* t]m 9 section #bja7ss7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7a74 #c4 ,regulation ( 9 vitro cl9ical te/s ,! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq47 is am5d$-- 7#a7 by am5d+ ! head+ ( *apt] ,v to read z foll[s3 ,drugs1 ,devices1 & ,9 ,vitro ,cl9ical ,te/s2 & 7#b7 by add+ at ! end ( *apt] ,v ! foll[+3 ,j ,9 ,vitro ,cl9ical ,te/s #ehg4 ,def9itions ,9 ?is sub*apt]3 7#a7 ,analytical validity ,! t]m analytical validity means1 ) respect to an 9 vitro cl9ical te/1 ! ability ( ! 9 vitro cl9ical te/1 to id5tify1 measure1 detect1 calculate1 or analyze 7or assi/ 9 su* id5tification1 measurem5t1 detection1 calculation1 or analysis (7 "o or m analytes1 biom>k]s1 sub/ances1 or o!r t>gets int5d$ to be id5tifi$1 measur$1 detect$1 calculat$1 or analyz$ by ! te/4 7#b7 ,applicable /&>d ,! t]m applicable /&>d1 ) respect to an 9 vitro cl9ical te/1 means a reasonable assurance ( analytical & cl9ical validity = its indications = use1 & a reasonable assurance ( safety = individuals :o come into contact ) su* 9 vitro cl9ical te/1 except t su* t]m1 ) respect to specim5 receptacles & te/ in/rum5ts1 means a reasonable assurance ( analytical validity = its indications = use & safety = individuals :o come into contact ) su* specim5 receptacle or te/ in/rum5t4 7#c7 ,cl9ical use ,! t]m cl9ical use means ! op]ation1 application1 or function+ ( an 9 vitro cl9ical te/ = ! purpose = :i* x is int5d$ z describ$ 9 section #bja7ss77#a74 7#d7 ,cl9ical validity ,! t]m cl9ical validity means ! ability ( an 9 vitro cl9ical te/ to a*ieve ! purpose = :i* x is int5d$ z describ$ 9 section #bja7ss77#a74 7#e7 ,compon5t or "p ,! t]m compon5t or "p means a sub/ance1 piece1 "p1 raw mat]ial1 s(tw>e1 firmw>e1 label+1 or assembly1 includ+ reag5ts1 t is int5d$ to be includ$ z an aspect ( an 9 vitro cl9ical te/ describ$ 9 section #bja7ss77#a74 7#f7 ,develop ,! t]m develop1 ) respect to an 9 vitro cl9ical te/1 means-- 7,a7 design+1 validat+1 produc+1 manufactur+1 remanufactur+1 label+1 adv]tis+1 propagat+1 import+1 or assembl+ an 9 vitro cl9ical te/2 7,b7 modify+ an 9 vitro cl9ical te/1 includ+ modify+ ! indications = use ( ! 9 vitro cl9ical te/1 or modify+ an article to be an 9 vitro cl9ical te/2 or 7,c7 e/abli%+ a te/ sy/em z describ$ or includ$ 9 a te/ protocol develop$ by ano!r entity unless su* te/ protocol is li/$ z an 9 vitro cl9ical te/ 9 ! compreh5sive te/ in=mation sy/em e/abli%$ "u section #ehg,t by t o!r entity4 7#g7 ,develop] ,! t]m develop] means a p]son :o engages 9 developm5t z describ$ 9 p>agraph 7#f71 except ! t]m does n include a laboratory t-- 7,a7 is c]tifi$ by ! ,secret>y "u section #cec ( ! ,public ,heal? ,s]vice ,act2 & 7,b7 assembles = use solely )9 t laboratory1 )\t o!rwise develop+1 an 9 vitro cl9ical te/ appropriately li/$ 9 ! compreh5sive te/ in=mation sy/em e/abli%$ "u section #ehg,t by a diff]5t p]son4 7#h7 ,fir/-(-a-k9d ,! t]m fir/-(-a-k9d1 ) respect to an 9 vitro cl9ical te/1 means t su* te/ has any novel comb9ation ( ! elem5ts specifi$ 9 p>agraph 7#aj7 t diff]s f 9 vitro cl9ical te/s t already are legally available 9 ! ,unit$ ,/ates1 except = su* te/s (f]$ "u section #ehg;,c7a77#c71 #ehg;,c7a77#d71 or #ehg;,g4 7#i7 ,high-risk ,! t]m high-risk1 ) respect to an 9 vitro cl9ical te/ or category ( 9 vitro cl9ical te/s1 means t an undetect$ inaccurate result f su* te/1 or su* category ( te/s1 :5 us$ z int5d$-- 7,a7 7i7 is reasonably likely to result 9 s]i\s or irrev]sible h>m or dea? to a pati5t or pati5ts1 or w\ld o!rwise cause s]i\s h>m to ! public heal?2 or 7ii7 is reasonably likely to result 9 ! abs5ce1 significant delay1 or discont9uation ( life-support+ or life-su/a9+ m$ical treatm5t2 & 7,b7 mitigat+ measures are n able to be e/abli%$ & appli$ to prev5t1 mitigate1 or detect ! inaccurate result1 or o!rwise suffici5tly mitigate ! risk result+ f an undetect$ inaccurate result describ$ 9 subp>agraph 7,a71 su* t ! te/ w\ld be mod]ate-risk or l[-risk4 7#aj7 ,indications = use ,! t]m indications = use1 ) respect to an 9 vitro cl9ical te/1 means ! foll[+ elem5ts3 7,a7 ,sub/ance or sub/ances measur$ by ! 9 vitro cl9ical te/1 su* z an analyte1 prote91 or pa?og54 7,b7 ,te/ me?od4 7,c7 ,te/ purpose or purposes1 z describ$ 9 section #bja7ss77#a74 7,d7 ,diseases or conditions = :i* ! 9 vitro cl9ical te/ is int5d$ = use1 includ+ int5d$ pati5t populations4 7,e7 ,context ( use1 su* z 9 a cl9ical laboratory1 9 a heal? c>e facility1 prescription home use1 ov]-!-c\nt] use1 or direct-to-consum] te/+4 7#aa7 ,in/rum5t 7,a7 ,9 g5]al ,! t]m in/rum5t means an analytical or pre-analytical in/rum5t4 7,b7 ,analytic in/rum5t ,! t]m analytic in/rum5t means an 9 vitro cl9ical te/ t is h>dw>e int5d$ by ! develop] to be us$ ) "o or m o!r 9 vitro cl9ical te/s to g5]ate a cl9ical te/ result1 includ+ s(tw>e us$ to effectuate ! functionality ( ! h>dw>e4 7,c7 ,pre-analytical in/rum5t ,! t]m pre-analytical in/rum5t means an 9 vitro cl9ical te/ t is h>dw>e int5d$ by ! develop] solely to g5]ate an output = use exclusively ) "o or m analytical in/rum5ts z def9$ 9 subp>agraph 7,b7 & :i* does n itself g5]ate a cl9ical te/ result4 ,su* t]m may include s(tw>e us$ to effectuate ! h>dw>e's functionality4 7#ab7 ,in/rum5t family ,! t]m in/rum5t family means m ?an "o in/rum5t develop$ by ! same develop] = :i* ! develop] demon/rates & docum5ts1 ) respect to all su* in/rum5ts1 t all-- 7,a7 h ! same basic ar*itecture1 design1 & p]=mance *>act]i/ics2 7,b7 h ! same indications = use & capabilities2 7,c7 %>e ! same measurem5t pr9ciples1 detection me?ods1 & reaction conditions1 z applicable2 & 7,d7 produce ! same or simil> analytical results f samples ( ! same specim5 type or types4 7#ac7 ,laboratory op]ations ,! t]m laboratory op]ations-- 7,a7 means ! conduct ( a laboratory exam9ation or o!r laboratory proc$ure on mat]ials d]iv$ f ! human body1 includ+ ! conduct ( an 9 vitro cl9ical te/ & associat$ activities1 t is-- 7i7 regulat$ "u section #cec ( ! ,public ,heal? ,s]vice ,act2 & 7ii7 n relat$ to ! design1 analytical validation1 or cl9ical validation ( an 9 vitro cl9ical te/2 & 7,b7 includes-- 7i7 p]=m+ pre-analytical & po/-analytical processes = an 9 vitro cl9ical te/2 7ii7 /&>d op]at+ proc$ures & ! conduct !re(2 & 7iii7 prep>+ reag5ts or o!r te/ mat]ials t d n meet ! crit]ia = be+ an 9 vitro cl9ical te/ = cl9ical use4 7#ad7 ,l[-risk ,! t]m l[-risk1 ) respect to an 9 vitro cl9ical te/ or category ( 9 vitro cl9ical te/s1 means t an undetect$ inaccurate result f su* 9 vitro cl9ical te/1 or su* category ( 9 vitro cl9ical te/s1 :5 us$ z int5d$-- 7,a7 w\ld cause only m9imal or imm$iately rev]sible h>m1 & w\ld lead to only a remote risk ( adv]se pati5t impact or adv]se public heal? impact2 or 7,b7 suffici5t mitigat+ measures are able to be e/abli%$ & appli$ su* t ! 9 vitro cl9ical te/ meets ! /&>d describ$ 9 subp>agraph 7,a74 7#ae7 ,mitigat+ measures ,! t]m mitigat+ measures-- 7,a7 means controls1 /&>ds1 & o!r requirem5ts t ! ,secret>y det]m9es1 bas$ on evid5ce1 are necess>y-- 7i7 = an 9 vitro cl9ical te/1 or a category ( 9 vitro cl9ical te/s1 to meet ! applicable /&>d2 or 7ii7 to mitigate ! risk ( h>m ensu+ f an undetect$ inaccurate result or mis9t]pretation ( a result2 & 7,b7 may include1 z requir$ by ! ,secret>y1 z appropriate1 applicable requirem5ts reg>d+ label+1 con=mance to p]=mance /&>ds & cons5sus /&>ds1 p]=mance te/+1 submission ( cl9ical data1 adv]tis+1 website po/+ ( in=mation1 cl9ical /udies1 po/m>ket surveillance1 us] compreh5sion /udies1 tra9+1 & confirmatory laboratory1 cl9ical f9d+s1 ! hi/ory ( ! develop]1 ! role ( a heal? pr(essional 9 ! te/+ process1 su* z integration ( ! te/+ laboratory into ! direct m$ical c>e ( ! pati5t1 includ+ direct int]action betwe5 ! te/+ laboratory & treat+ physician1 or te/+4 7#af7 ,mod]ate-risk ,! t]m mod]ate-risk1 ) respect to an 9 vitro cl9ical te/ or category ( 9 vitro cl9ical te/s-- 7,a7 means a te/ or category ( te/s t is n high-risk "u ! crit]ia "u p>agraph 7#i7 or l[-risk "u ! crit]ia "u p>agraph 7#ad72 & 7,b7 may include a te/ or category ( te/s t1 :5 us$ z int5d$1 meet ! crit]ia specifi$ 9 p>agraph 7#i77;,a7 = high-risk1 b = :i* "o or m mitigat+ measures are able to be e/abli%$ & appli$ to prev5t1 mitigate1 or detect an inaccurate result or o!rwise suffici5tly mitigate ! risk result+ f an undetect$ inaccurate result1 b are n suffici5t su* t ! te/ is l[-risk "u ! crit]ia 9 p>agraph 7#ad74 7#ag7 ,specim5 receptacle ,! t]m specim5 receptacle means an 9 vitro cl9ical te/ int5d$ = tak+1 collect+1 hold+1 /or+1 or transport+ ( specim5s d]iv$ f ! human body or = prep>ation1 analysis1 or 9 vitro cl9ical exam9ation = purposes describ$ 9 section #bja7ss77#a74 7#ah7 ,te*nology ,! t]m te*nology-- 7,a7 means a set ( control me*anisms1 en]gy s\rces1 or op]at+ pr9ciples-- 7i7 t d n diff] significantly among multiple 9 vitro cl9ical te/s2 & 7ii7 = :i* design & developm5t 7includ+ analytical & cl9ical validation1 z applicable7 ( ! te/s w\ld be address$ 9 a simil> mann] or ?r\gh simil> proc$ures2 & 7,b7 may include clot detection1 colorimetric 7non-immunoassay71 electro*emical 7non-immunoassay71 enzymatic 7non-immunoassay71 fl[ cytometry1 fluorometry 7non-immunoassay71 immunoassay1 mass spectrometry or *romatography1 microbial culture1 next g5]ation sequ5c+1 nephlometric or turbidimetric 7non-immunoassay71 s+leplex or multiplex non-,,ngs nucleic acid analysis1 slide-bas$ te*nology1 spectroscopy1 & any o!r te*nology1 z ! ,secret>y det]m9es appropriate4 7#ai7 ,te/ ,! t]m te/1 unless o!rwise provid$1 means an 9 vitro cl9ical te/4 7#bj7 ,valid sci5tific evid5ce ,! t]m valid sci5tific evid5ce-- 7,a7 means1 ) respect to an 9 vitro cl9ical te/1 evid5ce t-- 7i7 has be5 g5]at$ & evaluat$ by p]sons qualifi$ by tra9+ or exp]i5ce to d s1 us+ proc$ures g5]ally accept$ by o!r p]sons s qualifi$2 & 7ii7 =ms an appropriate basis = conclud+ by qualifi$ exp]ts :e!r ! applicable /&>d has be5 met by ! 9 vitro cl9ical te/2 & 7,b7 may include evid5ce describ$ 9 subp>agraph 7,a7 consi/+ (-- 7i7 pe]-review$ lit]ature2 7ii7 cl9ical guidel9es2 7iii7 reports ( significant human exp]i5ce ) an 9 vitro cl9ical te/2 7iv7 b5* /udies2 7v7 case /udies or hi/ories2 7vi7 cl9ical data2 7vii7 cons5sus /&>ds2 7viii7 ref]5ce /&>ds2 7ix7 data regi/ries2 7x7 po/m>ket data2 7xi7 real _w data2 7xii7 cl9ical trials2 & 7xiii7 data collect$ 9 c\ntries o!r ?an ! ,unit$ ,/ates if su* data are demon/rat$ to be appropriate = ! purpose ( mak+ a regulatory det]m9ation "u ?is sub*apt]4 #ehg;,a4 ,regulation ( 9 vitro cl9ical te/s 7a7 ,9 g5]al ,no p]son %all introduce or deliv] = introduction into int]/ate comm]ce any 9 vitro cl9ical te/1 unless-- 7#a7 an approval ( an application fil$ pursuant to subsection 7a7 or 7b7 ( section #ehg;,b is effective ) respect to su* 9 vitro cl9ical te/2 7#b7 ! 9 vitro cl9ical te/ is (f]$ "u a te*nology c]tification ord] "u section #ehg;,d7b77#a72 or 7#c7 ! te/ is exempt "u sections #ehg;,c or #ehg;,g f ! requirem5ts ( section #ehg;,b4 7b7 ,transf] or sale ( ,9 vitro cl9ical te/s 7#a7 ,transf] & assumption ( regulatory obligations ,if own]%ip ( an 9 vitro cl9ical te/ is sold or transf]r$ 9 su* mann] t ! develop] transf]s ! regulatory submissions & obligations applicable "u ?is sub*apt] ) respect to ! te/1 ! transf]ee or pur*as] becomes ! develop] ( ! te/ & %all h all regulatory obligations applicable to su* a te/ "u ?is sub*apt]4 ,! transf]ee or pur*as] %all update ! regi/ration & li/+ in=mation "u section #ehg;,j = ! 9 vitro cl9ical te/4 7#b7 ,transf] or sale ( prem>ket approval 7,a7 ,notice requir$ ,if a develop] ( an 9 vitro cl9ical te/ transf]s or sells ! approval ( ! 9 vitro cl9ical te/1 ! transf]or or sell] %all-- 7i7 submit a notice ( ! transf] or sale to ! ,secret>y & update ! regi/ration & li/+ in=mation "u section #ehg;,j = ! 9 vitro cl9ical te/2 & 7ii7 submit a supplem5t to an application if requir$ "u section #ehg;,b7h74 7,b7 ,effective date ( approval transf] ,a transf] or sale describ$ 9 subp>agraph 7,a7 %all become effective ^u completion ( a transf] or sale describ$ 9 p>agraph 7#a7 or ! approval ( a supplem5t to an application "u section #ehg;,b7h7 if requir$1 :i*ev] is lat]4 ,! transf]ee or pur*as] %all update ! regi/ration & li/+ in=mation "u section #ehg;,j = ! 9 vitro cl9ical te/ )9 #ae cal5d> days ( ! effective date ( ! transf] or sale4 7#c7 ,transf] or sale ( te*nology c]tification 7,a7 ,requirem5ts = transf] or sale ( te*nology c]tification ,an unexpir$ te*nology c]tification c be transf]r$ or sold if ! transf]ee or pur*as]-- 7i7 is an eligible p]son "u section #ehg;,d7a77#b72 & 7ii7 ma9ta9s1 ^u su* transf] or sale1 te/ design & quality requirem5ts1 processes & proc$ures "u ! scope ( te*nology c]tification1 & scope ( ! te*nology c]tification id5tifi$ 9 ! applicable te*nology c]tification ord]4 7,b7 ,notice requir$ ,if a develop] ( an 9 vitro cl9ical te/ transf]s or sells a te*nology c]tification ord] t has n expir$1 ! transf]or or sell] %all submit a notice ( ! transf] or sale to ! ,secret>y & %all update ! regi/ration & li/+ in=mation "u section #ehg;,j = all 9 vitro cl9ical te/s cov]$ by ! te*nology c]tification4 7,c7 ,effective date ( te*nology c]tification transf] ,! transf] ( a te*nology c]tification %all become effective ^u completion ( a transf] or sale describ$ 9 subp>agraph 7,a74 ,! transf]ee or pur*as] %all update ! regi/ration & li/+ in=mation "u section #ehg;,j = ! 9 vitro cl9ical te/ )9 #cj cal5d> days ( ! effective date ( ! te*nology c]tification transf]4 7,d7 ,new te*nology c]tification requir$ ,if ! requirem5ts ( subp>agraph 7,a77ii7 are n met1 ! te*nology c]tification ord] may n be transf]r$ & ! transf]ee or pur*as] ( an 9 vitro cl9ical te/ is requir$ to submit an application = te*nology c]tification & obta9 a te*nology c]tification ord] prior to (f]+ ! te/ = cl9ical use4 7c7 ,regulations ,! ,secret>y may issue regulations to implem5t ?is sub*apt]4 #ehg;,b4 ,prem>ket review 7a7 ,application 7#a7 ,fil+ ,any develop] may file ) ! ,secret>y an application = prem>ket approval ( an 9 vitro cl9ical te/ "u ?is subsection4 7#b7 ,transp>5cy & pr$ictability ,if a develop] files a prem>ket application "u ?is section & provides any additional docum5tation requir$ "u section #ehg;,d1 ! 9 vitro cl9ical te/ t is ! subject ( ! prem>ket application may be utiliz$ z ! repres5tative 9 vitro cl9ical te/ review$ by ! ,secret>y to support a te*nology c]tification ord] "u section #ehg;,d4 7#c7 ,application cont5t ,an application submitt$ "u p>agraph 7#a7 %all include ! foll[+1 9 su* =mat z ! ,secret>y specifies3 7,a7 ,g5]al in=mation reg>d+ ! 9 vitro cl9ical te/1 includ+-- 7i7 ! "n & address ( ! applicant2 7ii7 ! table ( cont5ts = ! application & ! id5tification ( ! in=mation ! applicant claims z trade secret or confid5tial comm]cial or f9ancial in=mation2 7iii7 a description ( ! te/'s design & int5d$ use1 includ+ ! indications = use2 & 7iv7 a description reg>d+ te/ function & p]=mance *>act]i/ics4 7,b7 ,a summ>y ( ! data & in=mation 9 ! application = ! 9 vitro cl9ical te/1 includ+-- 7i7 a brief description ( ! =eign & dome/ic m>ket+ hi/ory ( ! te/1 if any1 includ+ a li/ ( all c\ntries 9 :i* ! te/ has be5 m>ket$ & a li/ ( all c\ntries 9 :i* ! te/ has be5 )drawn f ! m>ket = any reason relat$ to ! ability ( ! 9 vitro cl9ical te/ to meet ! applicable /&>d1 if kn[n by ! applicant2 7ii7 a description ( b5efit & risk consid]ations relat$ to ! 9 vitro cl9ical te/1 includ+ a description ( any applicable adv]se effects ( ! te/ on heal? & h[ su* adv]se effects h be51 or w be1 mitigat$2 7iii7 a risk assessm5t ( ! te/2 & 7iv7 a description ( h[ ! data & in=mation 9 ! application con/itute valid sci5tific evid5ce & support a %[+ t ! te/ meets ! applicable /&>d "u section #ehg7b74 7,c7 ,! signature ( ! develop] fil+ ! prem>ket application or an au?oriz$ repres5tative4 7,d7 ,a bibliography ( applicable publi%$ reports & a description ( any /udies conduct$1 includ+ any unpubli%$ /udies relat$ to su* te/1 t are kn[n or t %\ld reasonably be kn[n to ! applicant1 & a description ( data & in=mation relevant to ! evaluation ( :e!r ! te/ meets ! applicable /&>d4 7,e7 ,applicable in=mation reg>d+ ! me?ods us$ 91 & ! facilities or controls us$ =1 ! developm5t ( ! te/ to demon/rate compliance ) ! applicable quality requirem5ts "u section #ehg,k4 7,f7 ,in=mation demon/rat+ compliance ) any relevant & applicable-- 7i7 mitigat+ measures "u section #ehg;,e2 & 7ii7 /&>ds e/abli%$ or recogniz$ "u section #ead prior to ! date ( enactm5t ( ! ,,valid ,act ( #bjbc1 or1 aft] applicable /&>ds are e/abli%$ or recogniz$ "u section #ehg,r1 ) su* /&>ds4 7,g7 ,valid sci5tific evid5ce to support t ! te/ meets ! applicable /&>d1 :i* %all include-- 7i7 summ>y in=mation = all support+ validation /udies p]=m$1 includ+ a description ( ! objective ( ! /udy1 a description ( ! exp]im5tal design ( ! /udy1 a description ( any limitations ( ! /udy1 a brief description ( h[ ! data 7 collect$ & analyz$1 a brief description ( ! results ( ea* /udy1 & conclusions drawn f ea* /udy2 7ii7 raw data = ea* /udy1 :i* may include1 z applicable1 tabulations ( data & results2 & 7iii7 = noncl9ical laboratory /udies involv+ ! te/1 if applicable1 a /atem5t t /udies 7 conduct$ 9 compliance ) applicable good laboratory practices4 7,h7 ,to ! ext5t ! application seeks au?orization to make modifications to ! te/ )9 ! scope ( ! approval t are n o!rwise p]mitt$ )\t prem>ket review "u ?is sub*apt]1 a propos$ *ange protocol t includes validation proc$ures & acceptance crit]ia = anticipat$ modifications t c\ld be made to ! te/ )9 ! scope ( ! approval4 7,i7 ,propos$ label+1 9 accordance ) ! requirem5ts ( section #ehg,l4 7,j7 ,su* o!r data or in=mation z ! ,secret>y may require 9 accordance ) ! lea/ burd5some requirem5ts "u section #ehg;,,aa7c74 7#d7 ,regulation = prem>ket & abbreviat$ prem>ket applications ,n lat] ?an #c ye>s aft] ! date ( enactm5t ( ! ,,valid ,act ( #bjbc1 ! ,secret>y %all promulgate f9al regulations detail+ ! in=mation to be provid$ 9 a prem>ket application & abbreviat$ prem>ket application "u ?is section4 7#e7 ,refuse to file a prem>ket or abbreviat$ prem>ket application ,! ,secret>y may refuse to file an application "u ?is section only = lack ( complet5ess or legibility ( ! application4 ,if1 aft] receipt ( an application "u ?is section1 ! ,secret>y refuses to file su* an application1 ! ,secret>y %all provide to ! develop]1 )9 #de cal5d> days ( receipt ( su* application submitt$ "u ?is subsection or )9 #cj cal5d> days ( receipt ( an application submitt$ "u subsection 7b71 a description ( ! reason = su* refusal1 & id5tify ! in=mation requir$1 if any1 to all[ = ! fil+ ( ! application4 7#f7 ,sub/antive review = defici5t application ,if1 aft] receipt ( an application "u ?is section1 ! ,secret>y det]m9es t any portion ( su* application is mat]ially defici5t1 ! ,secret>y %all provide to ! applicant a description ( su* mat]ial defici5cies & ! in=mation requir$ to resolve su* defici5cies4 7#g7 ,inspections ,) respect to an application "u p>agraph 7#a71 preapproval inspections au?oriz$ by an employee ( ! ,food & ,drug ,adm9i/ration or a p]son accr$it$ "u section #ehg,q ne$ n occur unless reque/$ by ! ,secret>y4 7b7 ,abbreviat$ prem>ket review 7#a7 ,9 g5]al ,any develop] may file ) ! ,secret>y an application = abbreviat$ prem>ket approval =-- 7,a7 an in/rum5t2 7,b7 a specim5 receptacle2 7,c7 an 9 vitro cl9ical te/ t is mod]ate-risk2 or 7,d7 an 9 vitro cl9ical te/ t is det]m9$ by ! ,secret>y to be eligible = abbreviat$ prem>ket review "u section #ehg;,f7a77#a77;,b74 7#b7 ,application cont5t ,an application "u p>agraph 7#a7 %all include-- 7,a7 ! in=mation requir$ = applications submitt$ "u subsection 7a77#c71 except t applications "u p>agraph 7#a7 ne$ n include-- 7i7 quality requirem5t in=mation2 or 7ii7 raw data1 unless reque/$ 9 writ+ by ! ,secret>y1 9 accordance ) ! lea/ burd5some requirem5ts "u section #ehg;,,aa7c71 & ) sup]visory review & concurr5ce prior to issuance ( su* reque/2 & 7,b7 data1 z applicable1 to support s(tw>e validation1 electromagnetic compatibility1 & electrical safety1 & in=mation demon/rat+ compliance ) ma9ta9+ quality sy/ems docum5tation4 7#c7 ,safety in=mation ,! develop] ( an 9 vitro cl9ical te/ specim5 receptacle review$ "u ?is subsection %all ma9ta9 safety in=mation = su* specim5 receptacle4 7#d7 ,inspections ,) respect to an application "u p>agraph 7#a71 preapproval inspections %all n be requir$ unless reque/$ 9 writ+ by ! ,secret>y1 aft] sup]visory review & concurr5ce1 because su* inspection is consid]$ necess>y to complete ! review4 7c7 ,in/rum5ts & in/rum5t families 7#a7 ,9 g5]al ,a develop] ( an in/rum5t family %all file ) ! ,secret>y an application = prem>ket approval ( "o v]sion ( an in/rum5t "u ?is subsection4 ,any modifi$ v]sions ( ! in/rum5t t g5]ate a new in/rum5t )9 ! same in/rum5t family %all be exempt f prem>ket review requirem5ts ( ?is section1 provid$ t ! develop] ( su* in/rum5t or in/rum5t family-- 7,a7 ma9ta9s docum5tation t ! new in/rum5t is "p ( ! in/rum5t family1 z def9$ 9 section #ehg2 7,b7 p]=ms1 docum5ts1 & ma9ta9s a risk assessm5t 7z describ$ 9 subsection 7a77#c77;,b77iii77 ( ! new in/rum5t comp>$ to ! in/rum5t approv$ "u subsection 7b7 & no new risks are id5tifi$2 7,c7 p]=ms1 docum5ts1 & ma9ta9s validation & v]ification activities = ! new in/rum5t2 7,d7 makes su* docum5tation available to ! ,secret>y ^u reque/2 & 7,e7 regi/]s & li/s ! new in/rum5t 9 accordance ) section #ehg;,j4 7#b7 ,te/ kits & te/ protocols ,) reg>d to a te/ kit or te/ protocol t is approv$ "u ?is section = use on an approv$ in/rum5t or an in/rum5t exempt f prem>ket review1 includ+ an in/rum5t )9 an in/rum5t family "u ?is section1 a submission "u ?is section %all n be requir$ = su* te/ kit or te/ protocol 9 ord] = x to be us$ on a new in/rum5t )9 its in/rum5t family1 provid$ t-- 7,a7 use ( ! te/ kit or te/ protocol ) ! new in/rum5t does n-- 7i7 *ange ! claims = ! te/ kit or te/ protocol1 except z applicable1 claims reg>d+ an in/rum5t or in/rum5ts t c be us$ ) su* te/ kit or te/ protocol2 7ii7 adv]sely affect p]=mance ( ! te/ kit or te/ protocol2 or 7iii7 cause ! te/ kit or te/ protocol to no long] con=m ) p]=mance /&>ds requir$ "u section #ehg,r or comply ) any applicable mitigat+ measures "u section #ehg;,e1 conditions ( approval "u subsection 7e77#b77;,b71 or re/rictions "u section #ehg,o2 7,b7 ! te/ develop] does n id5tify any new risks = ! te/ kit or te/ protocol :5 us+ ! new in/rum5t aft] conduct+ a risk assessm5t2 7,c7 ! te/ develop] validates ! use ( ! new in/rum5t ) ! te/ kit or te/ protocol & ma9ta9s validation docum5tation2 7,d7 ! te/ kit or te/ protocol is n int5d$ = use-- 7i7 9 sett+s = :i* a c]tificate ( waiv] is 9 effect "u section #cec ( ! ,public ,heal? ,s]vice ,act2 7ii7 )\t a prescription2 7iii7 at home2 or 7iv7 9 te/+ donors1 donations1 & recipi5ts ( blood1 blood compon5ts1 human cells1 tissues1 cellul>-bas$ products1 or tissue-bas$ products2 7,e7 ! te/ develop] makes ! docum5tation describ$ "u subp>agraph 7,c7 available to ! ,secret>y ^u reque/2 & 7,f7 ! te/ develop] updates ! li/+ in=mation = ! te/ kit or te/ protocol1 z applicable4 7d7 ,am5dm5ts to an application ,an applicant %all am5d an application submitt$ "u subsection 7a71 7b71 or 7f7 if ! applicant becomes aw>e ( in=mation t c\ld reasonably affect an evaluation "u subsection 7e7 ( :e!r ! approval /&>d has be5 met4 7e7 ,action on an application = prem>ket approval 7#a7 ,review 7,a7 ,disposition ,z promptly z possible1 b n lat] ?an #ij cal5d> days aft] an application "u subsection 7a7 is accept$ = submission 7unless ! ,secret>y det]m9es t an ext5sion is necess>y to review "o or m major am5dm5ts to ! application71 or n lat] ?an #fj cal5d> days aft] an application "u subsection 7b7 is accept$ = submission or a supplem5tal application "u subsection 7f7 is accept$ = submission1 ! ,secret>y1 aft] consid]+ any applicable report & recomm5dations pursuant to advisory committees "u section #ehg;,h1 %all issue an ord] approv+ ! application1 unless ! ,secret>y f9ds t ! gr\nds = approval 9 p>agraph 7#b7 are n met4 7,b7 ,reliance on propos$ label+ ,9 det]m9+ :e!r to approve or d5y an application "u p>agraph 7#a71 ! ,secret>y %all rely on ! indications = use includ$ 9 ! propos$ label+1 provid$ t su* label+ is n false or mislead+ bas$ on a fair evaluation ( all mat]ial facts4 7#b7 ,approval ( an application 7,a7 ,9 g5]al ,! ,secret>y %all approve an application submitt$ "u subsection 7a7 or 7b7 ) respect to an 9 vitro cl9ical te/ if ! ,secret>y f9ds t ! applicable /&>d is met1 &-- 7i7 ! applicant is 9 compliance ) applicable quality requirem5ts 9 section #ehg,k2 7ii7 ! application does n conta9 a false /atem5t or misrepres5tation ( mat]ial fact2 7iii7 bas$ on a fair evaluation ( all mat]ial facts1 ! propos$ label+ is tru?ful & non-mislead+ & complies ) ! requirem5ts ( section #ehg,l2 7iv7 ! applicant p]mits1 if reque/$1 au?oriz$ employees ( ! ,food & ,drug ,adm9i/ration & p]sons accr$it$ "u section #ehg,q an opportunity to inspect pursuant to section #gjd2 7v7 ! te/ con=ms ) any applicable p]=mance /&>ds requir$ "u section #ehg,r & any applicable mitigat+ measures "u section #ehg;,e2 7vi7 all noncl9ical laboratory /udies & cl9ical inve/igations involv+ human subjects t are describ$ 9 ! application 7 conduct$ 9 a mann] t meets ! applicable requirem5ts ( ?is sub*apt]2 & 7vii7 o!r data & in=mation ! ,secret>y may require "u subsection 7a77#c77;,j7 support approval4 7,b7 ,conditions ( approval ,an ord] approv+ an application pursuant to ?is section may require reasonable conditions ( approval = ! 9 vitro cl9ical te/1 :i* may include con=mance ) applicable mitigat+ measures "u section #ehg;,e1 re/rictions "u section #ehg,o1 & p]=mance /&>ds "u section #ehg,r4 7,c7 ,publication ,! ,secret>y %all publi% an ord] = ea* application approv$ pursuant to ?is p>agraph on ! public website ( ! ,food & ,drug ,adm9i/ration & make publicly available a summ>y ( ! data us$ to approve su* application4 ,9 mak+ ! ord] & summ>y publicly available1 ! ,secret>y %all n disclose any in=mation t-- 7i7 is confid5tial comm]cial in=mation or trade secret in=mation subject to section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code1 or section #aije ( title #ah1 ,unit$ ,/ates ,code2 or 7ii7 c\ld compromise national security4 7#c7 ,review ( d5ials ,an applicant ^: application submitt$ "u ?is section has be5 d5i$ approval "u ?is subsection may1 by petition fil$ n m ?an #fj cal5d> days aft] ! date on :i* ! applicant receives notice ( su* d5ial1 obta9 review ( ! d5ial 9 accordance ) section #ehg,p4 7f7 ,supplem5ts to an approv$ application 7#a7 ,risk analysis ,prior to implem5t+ any modification to an 9 vitro cl9ical te/1 ! hold] ( ! application approv$ "u subsection 7e7 = su* te/ %all p]=m risk analyses 9 accordance ) ?is subsection1 unless su* modification is includ$ 9 ! *ange protocol submitt$ by ! applicant & approv$ "u ?is section or exempt "u section #ehg;,c4 7#b7 ,supplem5t requirem5t 7,a7 ,9 g5]al ,if ! hold] ( an application ( an approv$ 9 vitro cl9ical te/ makes a modification to su* 9 vitro cl9ical te/1 except z provid$ 9 subp>agraph 7,c71 or o!rwise specifi$ by ! ,secret>y1 ! hold] ( ! application approv$ "u subsection 7e7 = an 9 vitro cl9ical te/ %all submit a supplem5tal application to ! ,secret>y4 ,! hold] ( ! application may n implem5t su* modification to ! 9 vitro cl9ical te/ until su* supplem5tal application is approv$4 ,! in=mation requir$ 9 a supplem5tal application is limit$ to :at is ne$$ to support ! *ange4 7,b7 ,*ange protocols ,! hold] ( an approv$ application may submit "u ?is p>agraph a supplem5tal application to modify ! *ange protocol = a te/ or to reque/ a *ange protocol = a te/4 7,c7 ,exceptions ,not)/&+ subp>agraphs 7,a7 & 7,b71 & s long z ! hold] ( an approv$ application submitt$ "u subsection 7a7 or 7b7 = an 9 vitro cl9ical te/ does n add a manufactur+ site1 or *ange activities at an exi/+ manufactur+ site1 ) respect to ! te/1 ! hold] ( an approv$ application may1 )\t submission ( a supplem5tal application1 implem5t ! foll[+ modifications to ! te/3 7i7 ,modifications 9 accordance ) an approv$ *ange protocol "u subsection 7a77#c77;,h74 7ii7 ,modifications t are exempt "u section #ehg;,c7a77#f74 7iii7 ,label+ *anges t are appropriate to address a safety conc]n1 except su* label+ *anges t include any ( ! foll[+ rema9 subject to subp>agraph 7,a73 7,i7 ,a *ange to ! indications = use ( ! te/4 7,,ii7 ,a *ange to ! p]=mance claims made ) respect to ! te/4 7,,iii7 ,a *ange t adv]sely affects p]=mance ( ! te/4 7,d7 ,report+ = c]ta9 modifications made pursuant to a *ange protocol ,! hold] ( an application approv$ "u subsection 7e71 ) an approv$ *ange protocol "u subsection 7a77#b77;,h7 = su* 9 vitro cl9ical te/ %all-- 7i7 report any modification to su* te/ made pursuant to su* *ange protocol approv$ "u subsection 7a77#c77;,h7 9 a submission "u section #ehg;,j7c77#b77;,b72 & 7ii7 include 9 su* report-- 7,i7 a description ( ! modification2 7,,ii7 ! rationale = implem5t+ su* modification2 & 7,,iii7 z applicable1 a summ>y ( ! evid5ce support+ t ! te/1 z modifi$1 meets ! applicable /&>d1 complies ) p]=mance /&>ds requir$ "u section #ehg,q1 & complies ) any mitigat+ measures e/abli%$ "u section #ehg;,e & any re/rictions "u section #ehg,o4 7,e7 ,report+ = c]ta9 safety relat$ label+ *anges ,! hold] ( ! application = an 9 vitro cl9ical te/ approv$ "u subsection 7e7 %all-- 7i7 report to ! ,secret>y any modification to ! te/ describ$ 9 subp>agraph 7,c77iii7 n m ?an #cj days aft] ! date on :i* ! te/1 ) ! modification1 is introduc$ into int]/ate comm]ce2 & 7ii7 include 9 ! report-- 7,i7 a description ( ! *ange or *anges2 7,,ii7 ! rationale = implem5t+ su* *ange or *anges2 & 7,,iii7 a description ( h[ ! *ange or *anges 7 evaluat$4 7#c7 ,cont5ts ( supplem5t ,unless o!rwise specifi$ by ! ,secret>y1 a supplem5t "u ?is subsection %all include-- 7,a7 = modifications o!r ?an manufactur+ site *anges requir+ a supplem5t-- 7i7 a description ( ! modification2 7ii7 data relevant to ! modification to demon/rate t ! applicable /&>d is met1 n to exce$ data requirem5ts = ! orig9al submission2 7iii7 acceptance crit]ia2 & 7iv7 any revis$ label+2 & 7,b7 = manufactur+ site *anges-- 7i7 ! in=mation li/$ 9 subp>agraph 7,a72 & 7ii7 in=mation reg>d+ ! me?ods us$ 91 or ! facilities or controls us$ =1 ! developm5t ( ! te/ to demon/rate compliance ) ! applicable quality requirem5ts "u section #ehg,k4 7#d7 ,additional data ,! ,secret>y may require1 :5 necess>y1 data to evaluate a modification to an 9 vitro cl9ical te/ t is 9 addition to ! data o!rwise requir$ "u ! prec$+ p>agraphs if ! data reque/ is 9 accordance ) ! lea/ burd5some requirem5ts "u section #ehg;,,aa7c74 7#e7 ,conditions ( approval ,9 an ord] approv+ a supplem5t "u ?is subsection1 ! ,secret>y may require conditions ( approval = ! 9 vitro cl9ical te/1 includ+ compliance ) re/rictions "u section #ehg,o & con=mance to p]=mance /&>ds "u section #ehg,r4 7#f7 ,approval ,! ,secret>y %all approve a supplem5t "u ?is subsection if-- 7,a7 ! data demon/rate t ! modifi$ 9 vitro cl9ical te/ meets ! applicable /&>d2 & 7,b7 ! hold] ( ! application approv$ "u subsection 7e7 = ! te/ has demon/rat$ compliance ) applicable quality & inspection requirem5ts1 z applicable & appropriate4 7#g7 ,publication ,! ,secret>y %all publi% on ! public website ( ! ,food & ,drug ,adm9i/ration notice ( any ord] approv+ a supplem5t "u ?is subsection provid$ t do+ s does n disclose any in=mation t-- 7,a7 is trade secret or confid5tial comm]cial or f9ancial in=mation2 or 7,b7 c\ld compromise national security4 7#h7 ,review ( d5ial ,an applicant ^: supplem5t "u ?is subsection has be5 d5i$ approval may1 by petition fil$ on or be=e ! #fj? cal5d> day aft] ! date ^u :i* ! applicant receives notice ( su* d5ial1 obta9 review ( ! d5ial 9 accordance ) section #ehg,p4 7g7 ,)drawal & tempor>y susp5sion ( approval 7#a7 ,ord] )draw+ approval 7,a7 ,9 g5]al ,! ,secret>y may1 aft] provid+ due notice & an opportunity = an in=mal he>+ to ! hold] ( an approv$ application = an 9 vitro cl9ical te/ "u ?is section1 issue an ord] )draw+ approval ( ! application if ! ,secret>y f9ds t-- 7i7 ! gr\nds = approval "u subsection 7e7 are no long] met2 7ii7 !re is a reasonable likelihood t ! te/ w\ld cause dea? or s]i\s adv]se heal? consequ5ces1 includ+ by caus+ ! abs5ce1 significant delay1 or discont9uation ( life-sav+ or life su/a9+ m$ical treatm5t2 7iii7 ! hold] ( ! approv$ application-- 7,i7 has fail$ to1 or repeat$ly or delib]ately fail$ to1 ma9ta9 records to make reports1 z requir$ "u section #ehg,m2 7,,ii7 has refus$ to p]mit access to1 or copy+ or v]ification ( su* records1 z requir$ "u section #gjd2 7,,iii7 has n compli$ ) ! requirem5ts ( section #ehg,k2 or 7,,iv7 has n compli$ ) any mitigat+ measure requir$ "u section #ehg;,e or re/riction "u section #ehg,o2 or 7iv7 ! label+ ( su* 9 vitro cl9ical te/1 bas$ on a fair evaluation ( all mat]ial facts1 is false or mislead+ 9 any p>ticul> & 0 n correct$ )9 a reasonable "t aft] receipt ( writt5 notice f ! ,secret>y ( su* fact4 7,b7 ,cont5t ,an ord] "u subp>agraph 7,a7 )draw+ approval ( an application %all /ate ea* gr\nd = )drawal & %all notify ! hold] ( su* application #fj cal5d> days prior to issu+ su* ord]4 7,c7 ,publication ,! ,secret>y %all publi% any ord] "u subp>agraph 7,a7 on ! public website ( ! ,food & ,drug ,adm9i/ration provid$ t do+ s does n disclose-- 7i7 any in=mation t is trade secret or confid5tial comm]cial or f9ancial in=mation2 or 7ii7 any o!r in=mation t ! ,secret>y det]m9es1 if publi%$1 c\ld compromise national security4 7#b7 ,ord] ( tempor>y susp5sion ,if1 aft] provid+ due notice & an opportunity = an in=mal he>+ to ! hold] ( an approv$ application = an 9 vitro cl9ical te/ "u ?is section1 ! ,secret>y det]m9es1 bas$ on sci5tific evid5ce1 t !re is a reasonable likelihood t ! 9 vitro cl9ical te/ w\ld cause dea? or s]i\s adv]se heal? consequ5ces1 su* z by caus+ ! abs5ce1 significant delay1 or discont9uation ( life-sav+ or life-su/a9+ m$ical treatm5t1 ! ,secret>y %all1 by ord]1 tempor>ily susp5d ! approval ( ! application4 ,if ! ,secret>y issues su* an ord]1 ! ,secret>y %all proce$ exp$iti\sly "u p>agraph 7#a7 to )draw approval ( su* application4 7#c7 ,appeal )draw+ approval & ord]s ( tempor>y susp5sions ,an ord] ( )drawal or an ord] ( tempor>y susp5sion may be appeal$ "u #ehg,p4 #ehg;,c4 ,exemptions 7a7 ,9 g5]al ,! foll[+ 9 vitro cl9ical te/s are exempt f prem>ket review "u section #ehg;,b1 & may be lawfully (f]$ subject to o!r applicable requirem5ts ( ?is ,act3 7#a7 ,te/s exempt f section #eaj7k7 7,a7 ,exemption ,an 9 vitro cl9ical te/ is exempt f prem>ket review "u section #ehg;,b & may be lawfully (f]$ subject to ! o!r applicable requirem5ts ( ?is ,act1 if ! develop] ( ! 9 vitro cl9ical te/-- 7i7 ma9ta9s docum5tation demon/rat+ t ! te/ meets & cont9ues to meet ! crit]ia set =? 9 subp>agraph 7,b72 & 7ii7 makes su* docum5tation available to ! ,secret>y ^u reque/4 7,b7 ,crit]ia = exemption ,an 9 vitro cl9ical te/ is exempt z specifi$ 9 subp>agraph 7,a7 if su* te/-- 7i7 7,i7 7aa7 0 (f]$ = cl9ical use prior to ! date ( enactm5t ( ! ,,valid ,act ( #bjbc2 & 7bb7 imm$iately prior to su* date ( enactm5t 0 exempt pursuant to subsection 7l7 or 7m77#b7 ( section #eaj f ! requirem5ts = submission ( a report "u section #eaj7k72 or 7,,ii7 7aa7 0 n (f]$ = cl9ical use prior to su* date ( enactm5t2 7bb7 is n an in/rum5t2 & 7cc7 falls )9 a category ( te/s t 0 exempt f ! requirem5ts = submission ( a report "u section #eaj7k7 z ( su* date ( enactm5t 7includ+ class ,,ii devices & exclud+ class ,i devices describ$ 9 section #eaj7l772 7ii7 meets ! applicable /&>d z describ$ 9 section #ehg7b72 7iii7 is n (f]$ ) label+ & adv]tis+ t is false or mislead+2 & 7iv7 is n likely to cause or contribute to s]i\s adv]se heal? consequ5ces4 7,c7 ,effect on special controls ,= any 9 vitro cl9ical te/1 or category ( 9 vitro cl9ical te/s1 t is exempt f prem>ket review bas$ on ! crit]ia 9 subp>agraph 7,b71 any special control t appli$ to a device )9 a pr$ecessor category imm$iately prior to ! date ( enactm5t ( ! ,,valid ,act ( #bjbc %all be deem$ a mitigat+ measure applicable "u section #ehg;,e to an 9 vitro cl9ical te/ )9 ! successor category1 except to ! ext5t su* mitigat+ measure is )drawn or *ang$ 9 accordance ) section #ehg;,e4 7,d7 ,ne>-pati5t te/+ ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,,valid ,act ( #bjbc1 ! ,secret>y %all issue draft guidance indicat+ categories ( te/s t %all be exempt f prem>ket review "u section #ehg;,b :5 (f]$ = ne>-pati5t te/+ 7po9t ( c>e71 :i* 7 n exempt f submission ( a report "u section #eaj7k7 pursuant to subsection 7l7 or 7m77#b7 ( section #eaj & regulations impos+ limitations on exemption = 9 vitro devices int5d$ = ne>-pati5t te/+ 7po9t ( c>e74 7#b7 ,l[-risk te/s 7,a7 ,exemption ,an 9 vitro cl9ical te/ is exempt f prem>ket review "u section #ehg;,b & may be lawfully (f]$ subject to ! o!r applicable requirem5ts ( ?is ,act1 includ+ section #ehg;,j7b71 if su* te/ meets ! def9ition ( l[-risk "u section #ehg & if ! develop] ( ! te/-- 7i7 ma9ta9s docum5tation demon/rat+ t ! 9 vitro cl9ical te/ meets & cont9ues to meet ! crit]ia set =? 9 subp>agraph 7,b72 & 7ii7 makes su* docum5tation available to ! ,secret>y ^u reque/4 7,b7 ,crit]ia = exemption ,an 9 vitro cl9ical te/ is exempt z specifi$ 9 subp>agraph 7,a7 if-- 7i7 ! 9 vitro cl9ical te/ meets ! applicable /&>d z describ$ 9 #ehg7b72 7ii7 ! label+ & adv]tis+ are n false or mislead+2 7iii7 ! 9 vitro cl9ical te/ is n likely to cause or contribute to s]i\s adv]se heal? consequ5ces2 & 7iv7 ! 9 vitro cl9ical te/ falls )9 a category ( te/s li/$ z describ$ 9 subp>agraph 7,c74 7,c7 ,li/ ( l[-risk te/s 7i7 ,9 g5]al ,! ,secret>y %all ma9ta91 & make publicly available on ! website ( ! ,food & ,drug ,adm9i/ration1 a li/ ( 9 vitro cl9ical te/s1 & categories ( 9 vitro cl9ical te/s1 t are l[-risk 9 vitro cl9ical te/s = purposes ( ! exemption "u ?is p>agraph4 7ii7 ,inclusion ,! li/ "u clause 7i7 %all consi/ (-- 7,i7 all 9 vitro cl9ical te/s & categories ( 9 vitro cl9ical te/s t are exempt f prem>ket review pursuant to p>agraph 7#a7 or ?is p>agraph2 & 7,,ii7 all 9 vitro cl9ical te/s & categories ( 9 vitro cl9ical te/s t are designat$ by ! ,secret>y pursuant to subp>agraph 7,d7 z l[-risk = purposes ( ?is p>agraph4 7,d7 ,designation ( te/s & categories ,)\t reg>d to sub*apt] ,,ii ( *apt] #e ( title #e1 ,unit$ ,/ates ,code1 ! ,secret>y may designate1 9 addition to ! te/s & categories describ$ 9 subp>agraph 7,c77i71 additional 9 vitro cl9ical te/s1 & categories ( 9 vitro cl9ical te/s1 z l[-risk 9 vitro cl9ical te/s = purposes ( ! exemption "u ?is p>agraph4 ,! ,secret>y may make su* a designation on ! ,secret>y's own initiative or 9 response to a reque/ by a develop] pursuant to subsection 7a7 or 7b7 ( section #ehg;,f4 ,9 mak+ su* a designation = a te/ or category ( te/s1 ! ,secret>y %all consid]-- 7i7 :e!r ! te/1 or category ( te/s1 is l[-risk2 7ii7 ! exi/5ce ( & ability to develop mitigat+ measures suffici5t = su* te/ category to meet ! l[-risk /&>d2 & 7iii7 su* o!r factors z ! ,secret>y det]m9es to be appropriate = ! protection ( ! public heal?4 7#c7 ,humanit>ian te/ exemption 7,a7 ,9 g5]al ,an 9 vitro cl9ical te/ t meets ! crit]ia "u subp>agraph 7,b7 is exempt f prem>ket review "u section #ehg;,b & may be lawfully (f]$ subject to ! o!r applicable requirem5ts ( ?is sub*apt]1 if ! develop] ( ! te/-- 7i7 ma9ta9s docum5tation 7:i* may include lit]ature citations 9 specializ$ m$ical j\rnals1 textbooks1 specializ$ m$ical society proce$+s1 & gov]nm5tal /ati/ics publications1 or1 if no su* /udies or lit]ature citations exi/1 cr$ible conclusions f appropriate rese>* or surveys7 demon/rat+ t su* te/ meets & cont9ues to meet ! crit]ia describ$ 9 ?is subsection2 & 7ii7 makes su* docum5tation available to ! ,secret>y ^u reque/4 7,b7 ,crit]ia = exemption ,an 9 vitro cl9ical te/ is exempt z describ$ 9 subp>agraph 7,a7 if-- 7i7 ! 9 vitro cl9ical te/ is int5d$ by ! develop] = use = a diagno/ic purpose =-- 7,i7 a noncontagi\s disease or condition t affects n m ?an #aj1jjj 7or su* o!r high] numb] det]m9$ by ! ,secret>y7 individuals 9 ! ,unit$ ,/ates p] ye>2 or 7,,ii7 a contagi\s disease or condition t affects n m ?an #a1ejj individuals 9 ! ,unit$ ,/ates p] ye>2 7ii7 ! 9 vitro cl9ical te/ meets ! applicable /&>d describ$ 9 section #ehg7b72 7iii7 ! label+ & adv]tis+ = ! 9 vitro cl9ical te/ are n false or mislead+2 7iv7 ! 9 vitro cl9ical te/ is n likely to cause or contribute to s]i\s adv]se heal? consequ5ces2 & 7v7 ! 9 vitro cl9ical te/ is n int5d$ = scre5+4 7,c7 ,exception = c]ta9 te/s ,an 9 vitro cl9ical te/ int5d$ to in=m ! use ( a specific individual or specific type ( biological product1 drug1 or device %all be eligible = an exemption f prem>ket review "u ?is subsection only if1 ! develop] submits a reque/ "u section #ehg;,f7e7 = in=mal fe$back & ! ,secret>y det]m9es t su* 9 vitro cl9ical te/ is eligible = an exemption f prem>ket review "u ?is subsection4 7#d7 ,cu/om te/s & l[-volume te/s ,an 9 vitro cl9ical te/ is exempt f prem>ket review "u section #ehg;,b1 quality requirem5ts "u section #ehg,k1 & li/+ requirem5ts "u section #ehg;,j1 & may be lawfully (f]$ subject to ! o!r applicable requirem5ts ( ?is ,act1 if-- 7,a7 su* 9 vitro cl9ical te/-- 7i7 is a te/ protocol p]=m$ = n m ?an #e pati5ts p] ye> 7or su* o!r high] numb] det]m9$ by ! ,secret>y71 9 a laboratory c]tifi$ by ! ,secret>y "u section #cec ( ! ,public ,heal? ,s]vice ,act t-- 7,i7 meets ! requirem5ts to p]=m te/s ( high-complexity 9 :i* ! te/ protocol 0 develop$2 or 7,,ii7 meets ! requirem5ts to p]=m te/s ( high-complexity )9 ! same corporate organization & hav+ common own]%ip by ! same p>5t corporation z ! laboratory 9 :i* su* te/ protocol 0 develop$2 or 7ii7 is an 9 vitro cl9ical te/ develop$ to diagnose a unique pa?ology or physical condition ( a specific pati5t or pati5ts 7includ+ an 9 vitro cl9ical te/ modifi$ = su* purpose71 ^u ! prescription or ord] ( a heal? c>e practition] lic5s$ to prescribe or ord] su* te/1 or a heal? c>e pr(essional or o!r specially qualifi$ p]son designat$ "u regulations to prescribe or ord] su* te/1 = :i* no o!r 9 vitro cl9ical te/ is comm]cially available 9 ! ,unit$ ,/ates1 & is-- 7,i7 n int5d$ = use ) respect to m ?an #e 7or su* o!r high] numb] det]m9$ by ! ,secret>y7 o!r pati5ts2 & 7,,ii7 n includ$ 9 any te/ m5u or template te/ report or o!r promotional mat]ials1 & is n o!rwise adv]tis$2 & 7,b7 ! develop] ( ! 9 vitro cl9ical te/-- 7i7 ma9ta9s docum5tation demon/rat+ t su* te/ meets ! applicable crit]ia describ$ 9 subp>agraph 7,a72 7ii7 makes su* docum5tation1 su* z a prescription ord] reque/+ ! cu/om te/ = an individual pati5t1 available to ! ,secret>y ^u reque/2 & 7iii7 in=ms ! ,secret>y1 on an annual basis1 9 a mann] prescrib$ by ! ,secret>y by guidance1 t su* te/ 0 (f]$4 7#e7 ,9 vitro cl9ical te/s "u a te*nology c]tification ord] ,an 9 vitro cl9ical te/ t is )9 ! scope ( a te*nology c]tification ord] "u section #ehg;,d is exempt f prem>ket review "u section #ehg;,b4 7#f7 ,modifi$ te/s 7,a7 ,9 g5]al ,an 9 vitro cl9ical te/ t is modifi$ is exempt f prem>ket review "u section #ehg;,b if-- 7i7 ! modification is made by-- 7,i7 ! develop] t obta9$ prem>ket approval = ! unmodifi$ v]sion ( ! te/ "u section #ehg;,b2 or 7,,ii7 a cl9ical laboratory c]tifi$ by ! ,secret>y "u section #cec ( ! ,public ,heal? ,s]vice ,act t meets ! requirem5ts = p]=m+ high complexity te/+1 to a lawfully (f]$ 9 vitro cl9ical te/1 includ+ ano!r develop]'s lawfully (f]$ 9 vitro cl9ical te/1 exclud+ inve/igational 9 vitro cl9ical te/s (f]$ "u section #ehg,s1 & ! modifi$ te/ is p]=m$-- 7aa7 9 ! same cl9ical laboratory 9 :i* x 0 develop$ = :i* a c]tification is /ill 9 effect "u section #cec t meets ! requirem5ts to p]=m te/s ( high complexity2 7bb7 by ano!r cl9ical laboratory = :i* a c]tificate is 9 effect "u section #cec t meets ! requirem5ts to p]=m te/s ( high complexity1 is )9 ! same corporate organization1 & has common own]%ip by ! same p>5t corporation z ! laboratory 9 :i* ! te/ 0 develop$2 or 7cc7 by a cl9ical laboratory = :i* a c]tificate is 9 effect "u section #cec t meets ! requirem5ts to p]=m te/s ( high complexity & is )9 a public heal? laboratory network coord9at$ or manag$ by ! ,c5t]s = ,disease ,control & ,prev5tion1 if ! te/ 0 develop$ by ! ,c5t]s = ,disease ,control & ,prev5tion or ano!r laboratory )9 su* public heal? laboratory network2 7ii7 ! modification does n-- 7,i7 con/itute a significant *ange to ! indications = use1 except = *anges to a specim5 type1 z specifi$ 9 ! guidance issu$ "u subp>agraph 7,e72 7,,ii7 cause ! te/ to no long] comply ) applicable mitigat+ measures "u section #ehg;,e or re/rictions "u section #ehg,o2 7,,iii7 significantly *ange p]=mance claims or significantly & adv]sely *ange p]=mance1 unless provid$ = "u an approv$ *ange protocol "u section #ehg;,b7a77#c77;,h72 or 7,,iv7 con/itute an adv]se *ange 9 ! safety ( ! 9 vitro cl9ical te/ = individuals :o come 9 contact ) ! 9 vitro cl9ical te/2 7iii7 ! te/ meets ! applicable /&>d z describ$ 9 section #ehg7b72 7iv7 ! label+ & adv]tis+ are n false or mislead+2 & 7v7 ! te/ is n likely to cause or contribute to s]i\s adv]se heal? consequ5ces4 7,b7 ,c]ta9 modifications ,a modification to ext5d specim5 /ability is exempt f prem>ket review "u section #ehg;,b if ! modifi$ te/ meets ! requirem5ts 9 clauses 7ii7 ?r\gh 7v7 ( subp>agraph 7,a74 7,c7 ,modifications "u a *ange protocol ,not)/&+ subp>agraph 7,a71 a modification made "u a *ange protocol pursuant to subsection 7a77#b77;,h7 ( section #ehg;,b is exempt f review "u su* section4 7,d7 ,docum5tation ,a p]son :o modifies an 9 vitro cl9ical te/ 9 a mann] t is a modification describ$ 9 ?is p>agraph %all-- 7i7 docum5t ! modification t 0 made & ! basis = det]m9+ t ! modification1 consid]+ ! *anges individually & collectively1 is a type ( modification describ$ 9 subp>agraph 7,a71 7,b71 or 7,c72 & 7ii7 provide su* docum5tation to ! ,secret>y ^u reque/ or inspection4 7,e7 ,guidance ,n lat] ?an #cj mon?s aft] ! date ( enactm5t ( ! ,,valid ,act ( #bjbc1 ! ,secret>y %all issue guidance reg>d+ ! 9 vitro cl9ical te/s t are modifi$ & exempt f prem>ket review "u section #ehg;,b pursuant to ?is p>agraph4 ,su* guidance %all include consid]ations = *anges to a specim5 type t may be made by a develop] )\t ! requirem5t ( prem>ket review "u #ehg;,b4 7b7 ,manual te/s 7#a7 ,exemption ,an 9 vitro cl9ical te/ is exempt f all requirem5ts ( ?is sub*apt] if ! output ( su* 9 vitro cl9ical te/ is ! result ( direct1 manual obs]vation1 )\t ! use ( automat$ in/rum5tation or s(tw>e = int]m$iate or f9al int]pretation1 by a qualifi$ laboratory pr(essional1 & su* 9 vitro cl9ical te/-- 7,a7 is develop$ & us$ )9 a s+le cl9ical laboratory = :i* a c]tificate is 9 effect "u section #cec ( ! ,public ,heal? ,s]vice ,act t meets ! requirem5ts "u section #cec = p]=m+ high-complexity te/+2 7,b7 is n a specim5 receptacle1 in/rum5t1 or an 9 vitro cl9ical te/ t includes an in/rum5t or specim5 receptacle t is n approv$ "u or exempt f section #ehg;,b2 7,c7 is n a high-risk te/1 or is a high-risk te/ t ! ,secret>y has det]m9$ meets at lea/ "o condition 9 p>agraph 7#b7 & is o!rwise appropriate = ?is exemption2 & 7,d7 is n int5d$ = te/+ donors1 donations1 or recipi5ts ( blood1 blood compon5ts1 human cells1 tissues1 cellul>-bas$ products1 or tissue-bas$ products4 7#b7 ,high-risk te/ limitation or condition ,a high-risk te/ may be exempt "u p>agraph 7#a7 f ! requirem5ts ( ?is sub*apt] only if-- 7,a7 no compon5ts or p>ts ( su* te/1 includ+ any reag5t1 is introduc$ into int]/ate comm]ce "u ! exemption "u subsection 7e71 & any article = tak+ or d]iv+ specim5s f ! human body us$ 9 conjunction ) ! te/ rema9s subject to ! requirem5ts ( ?is sub*apt]2 or 7,b7 ! te/ has be5 develop$ 9 accordance ) ! applicable te/ design & quality requirem5ts "u section #ehg,k4 7c7 ,public heal? surveillance activities 7#a7 ,9 g5]al ,! provisions ( ?is sub*apt] %all n apply to a te/ int5d$ by ! develop] to be us$ solely = public heal? surveillance activities4 7#b7 ,exclusion ,an 9 vitro cl9ical te/ us$ = public heal? surveillance activities is n exclud$ f ! provisions ( ?is sub*apt] pursuant to ?is subsection if su* te/ is int5d$ = use 9 mak+ cl9ical decisions = individual pati5ts4 7d7 ,g5]al laboratory equipm5t ,z set =? 9 section #bja7ss77#c77;,c71 g5]al purposes laboratory equipm5t is n an 9 vitro cl9ical te/s & is n subject to ! requirem5ts ( ?is sub*apt]4 7e7 ,compon5ts & ,p>ts 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 a compon5t or "p describ$ 9 section #bja7ss77#b77;,g7 is-- 7,a7 exempt f ! requirem5ts ( ?is sub*apt] if x is int5d$ = fur!r developm5t z describ$ 9 p>agraph 7#c72 or 7,b7 subject to ! requirem5ts ( ?is sub*apt] & regulat$ bas$ on its risk :5 us$ z int5d$ by ! develop]1 not)/&+ its subsequ5t use by a develop] z a compon5t1 "p1 or raw mat]ial ( ano!r 9 vitro cl9ical te/4 7#b7 ,inapplicability to o!r te/s ,not)/&+ p>agraph 7#a71 an 9 vitro cl9ical te/ t is describ$ 9 section #bja7ss77#a77;,b7 & t uses a compon5t or "p describ$ 9 su* subp>agraph %all be subject to ! requirem5ts ( ?is sub*apt]1 unless ! te/ is o!rwise exempt "u ?is section4 7#c7 ,fur!r developm5t ,a compon5t1 "p1 or raw mat]ial 7z describ$ 9 p>agraph 7#a77 is int5d$ = fur!r developm5t 7= purposes ( su* p>agraph7 if-- 7,a7 x is int5d$ solely = use 9 ! developm5t ( ano!r 9 vitro cl9ical te/2 & 7,b7 9 ! case ( su* a te/ t is introduc$ or deliv]$ = introduction into int]/ate comm]ce aft] ! date ( enactm5t ( ! ,,valid ,act ( #bjbc1 ! label+ ( su* te/ be>s ! foll[+ /atem5t3 ,?is product is int5d$ solely = fur!r developm5t ( an 9 vitro cl9ical te/ & is exempt f ,,fda regulation4 ,?is product mu/ be evaluat$ by ! 9 vitro cl9ical te/ develop] if x is us$ ) or 9 ! developm5t ( an 9 vitro cl9ical te/44 7f7 ,g5]al exemption au?ority ,! ,secret>y may1 by ord] publi%$ 9 ! ,f$]al ,regi/] foll[+ notice & an opportunity = comm5t1 exempt a class ( p]sons f any section "u ?is sub*apt] ^u a f9d+ t su* exemption is appropriate = ! protection ( ! public heal? & o!r relevant consid]ations4 7g7 ,o!r exemptions ,an 9 vitro cl9ical te/ t is int5d$ solely = use 9 =5sic analysis or law en=cem5t activity is exempt f ! requirem5ts ( ?is sub*apt]4 ,an 9 vitro cl9ical te/ t is int5d$ = use 9 mak+ cl9ical decisions = individual pati5ts1 or ^: individually id5tifiable results may be report$ back to an individual pati5t or ! pati5t's heal? c>e provid]1 ev5 if also int5d$ = =5sic analysis or law en=cem5t purposes1 is n int5d$ solely = =5sic analysis or law en=cem5t = purposes ( ?is subsection4 7h7 ,revocation 7#a7 ,9 g5]al ,! ,secret>y may revoke any exemption "u ?is section ) respect to 9 vitro cl9ical te/s ) ! same indications = use if new cl9ical in=mation indicates t ! exemption ( an 9 vitro cl9ical te/ or te/s f prem>ket review "u section #ehg;,b has a reasonable probability ( sev]e adv]se heal? consequ5ces1 includ+ ! abs5ce1 delay1 or discont9uation ( appropriate m$ical treatm5t4 7#b7 ,process ,any action "u p>agraph 7#a7 %all be made by publication ( a notice ( su* propos$ action on ! website ( ! ,food & ,drug ,adm9i/ration1 ! consid]ation ( comm5ts to a public docket on su* proposal1 & publication ( a f9al action on su* website )9 #fj cal5d> days ( ! close ( ! comm5t p]iod po/$ to su* public docket1 not)/&+ sub*apt] ,,ii ( *apt] #e ( title #e1 ,unit$ ,/ates ,code4 7i7 ,pre-,analytical in/rum5t ,a pre-analytical in/rum5t is exempt f prem>ket review "u section #ehg;,b & may be lawfully (f]$ subject to ! o!r applicable requirem5ts ( ?is ,act1 if ei!r ( ! foll[+ applies3 7#a7 ,su* in/rum5t provides additional in=mation reg>d+ ! sample or p]=ms an action on ! sample b is n prep>+ or process+ ! sample & does n p]=m any function ( an analytical in/rum5t4 ,su* types ( pre-analytical in/rum5ts include b>code read]s1 sample mov]s1 & sample id5tifi]s4 7#b7 ,su* in/rum5t processes or prep>es ! sample prior to use on an analytical in/rum5t1 does n p]=m any function ( an analytical in/rum5t1 & does n select1 isolate1 or prep>e a "p ( a sample bas$ on specific prop]ties4 ,su* types ( pre-analytical in/rum5ts may include sample mix]s1 ,,dna extractors & ^? us$ to dilute samples4 #ehg;,d4 ,te*nology c]tification 7a7 ,def9itions ,9 ?is section3 7#a7 ,eligible 9 vitro cl9ical te/ ,! t]m eligible 9 vitro cl9ical te/ means an 9 vitro cl9ical te/ t is n-- 7,a7 a compon5t or "p ( an 9 vitro cl9ical te/ z describ$ 9 section #bja7ss77#b77;,g7 unless x is a compon5t or "p & is regulat$ bas$ on its own risk "u section #ehg;,c7e77#a77;,b7 or z "p ( an o!rwise eligible 9 vitro cl9ical te/2 7,b7 an in/rum5t "u section #bja7ss77#b77;,d7 or an 9 vitro cl9ical te/ t includes an in/rum5t t is subject to section #ehg;,b1 b is n approv$ "u1 or exempt f1 section #ehg;,b2 7,c7 a specim5 receptacle "u section #bja7ss77#b77;,e7 or an 9 vitro cl9ical te/ t includes a specim5 receptacle t is subject to section #ehg;,b1 b is n approv$ "u1 or exempt f1 section #ehg;,b2 7,d7 an 9 vitro cl9ical te/1 includ+ reag5ts us$ 9 su* te/s1 int5d$ = use = te/+ donors1 donations1 & recipi5ts ( blood1 blood compon5ts1 human cells1 tissues1 cellul>-bas$ products1 or tissue-bas$ products2 7,e7 high-risk2 7,f7 a comb9ation product1 unless su* te/ has be5 det]m9$ to be eligible to be introduc$ into int]/ate comm]ce "u a te*nology c]tification ord] pursuant to ! regulatory pa?way designation process describ$ 9 section #ehg;,f1 or z describ$ 9 subsection 7k71 & ! drug or biological product con/itu5t "p complies ) ! requirem5ts ( section #ejc7;g7 applicable to ! drug or biological product2 or 7,g7 a fir/-(-a-k9d 9 vitro cl9ical te/1 unless su* te/ has be5 det]m9$ to be eligible to be introduc$ into int]/ate comm]ce "u a te*nology c]tification ord] pursuant to ! regulatory pa?way designation process describ$ 9 section #ehg;,f1 or z describ$ 9 subsection 7k74 7#b7 ,eligible p]son ,! t]m eligible p]son means an 9 vitro cl9ical te/ develop] unless su* develop]-- 7,a7 is a laboratory subject to section #cec ( ! ,public ,heal? ,s]vice ,act & does n h 9 effect a c]tificate applicable to ! category ( laboratory exam9ation or o!r proc$ure2 7,b7 0 a laboratory1 or an own] or op]ator or any employee ( a laboratory1 f\nd to h committ$ a significant violation ( section #cec ( ! ,public ,heal? ,s]vice ,act t result$ 9 a susp5d$1 revok$1 or limit$ c]tificate )9 ! #b-ye> p]iod prec$+ ! date ( ! submission ( ! application = a te*nology c]tificate "u subsection 7c7 & su* violation has n be5 resolv$2 or 7,c7 has be5 f\nd to h submitt$ in=mation to ! ,secret>y1 or o!rwise dissem9at$ in=mation1 t-- 7i7 made false or mislead+ /atem5ts relevant to ! requirem5ts ( ?is sub*apt]2 or 7ii7 violat$ any requirem5t ( ?is ,act1 :]e su* violation expos$ individuals to s]i\s risk ( illness1 injury1 or dea?1 unless-- 7,i7 su* violation has be5 resolv$2 or 7,,ii7 su* violation is n p]t95t to any 9 vitro cl9ical te/ )9 ! scope ( ! te*nology c]tification t su* develop] seeks4 7b7 ,applicability 7#a7 ,9 g5]al ,an 9 vitro cl9ical te/ is n subject to section #ehg;,b & may be introduc$ into int]/ate comm]ce if ! 9 vitro cl9ical te/-- 7,a7 is an eligible 9 vitro cl9ical te/2 7,b7 is develop$ by an eligible p]son2 7,c7 falls )9 ! scope ( a te*nology c]tification ord] issu$ "u ?is section & t is 9 effect2 7,d7 complies ) ! conditions ( ! te*nology c]tification ord]1 includ+ ) applicable mitigat+ measures "u section #ehg;,e1 re/rictions "u section #ehg,o1 & p]=mance /&>ds "u section #ehg,r2 & 7,e7 meets ! applicable /&>d describ$ 9 section #ehg7b74 7#b7 ,scope 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 ! scope ( a te*nology c]tification ord] issu$ "u ?is section %all apply to "o or m te*nologies ) multiple 9 vitro cl9ical te/s utiliz+ a te*nology t does n significantly diff] 9 control me*anisms1 en]gy s\rces1 or op]at+ pr9ciples & = :i* developm5t1 includ+ design1 & analytical & cl9ical validation1 ( ! 9 vitro cl9ical te/s w\ld be address$ ?r\gh simil> proc$ures1 & be no broad] ?an-- 7i7 a s+le te*nology type2 or 7ii7 a fix$ comb9ation ( te*nologies4 7,b7 ,te*nology type ,a te*nology type describ$ 9 ?is p>agraph may include clot detection1 colorimetric 7non-immunoassay71 electro*emical 7non-immunoassay71 enzymatic 7non-immunoassay71 fl[ cytometry1 fluorometry 7non-immunoassay71 immunoassay1 mass spectrometry or *romatography1 microbial culture1 next g5]ation sequ5c+1 nephlometric or turbidimetric 7non-immunoassay71 s+leplex or multiplex non-,,ngs nucleic acid analysis1 slide-bas$ te*nology1 spectroscopy1 & any o!r te*nology1 z ! ,secret>y det]m9es appropriate4 7c7 ,application = te*nology c]tification 7#a7 ,9 g5]al ,a develop] seek+ a te*nology c]tification ord] %all submit an application "u ?is subsection1 :i* %all conta9 ! in=mation specifi$ "u p>agraph 7#b74 7#b7 ,cont5t ( application ,a develop] t submits an application = a te*nology c]tification %all include all necess>y in=mation to make a %[+ t all eligible 9 vitro cl9ical te/s develop$ )9 ! scope ( ! te*nology c]tification ord] w meet ! applicable /&>d1 includ+-- 7,a7 ! "n & address ( ! develop]2 7,b7 a table ( cont5ts = ! application & ! id5tification ( ! in=mation ! develop] claims z trade secret or confid5tial comm]cial or f9ancial in=mation2 7,c7 ! signature ( ! individual fil+ ! application or an au?oriz$ repres5tative2 7,d7 a /atem5t id5tify+ ! scope ( ! propos$ te*nology c]tification int5d$ to be introduc$ into int]/ate comm]ce "u ! application2 7,e7 in=mation e/abli%+ t ! develop] submitt+ ! application is an eligible p]son2 7,f7 quality proc$ures %[+ t eligible 9 vitro cl9ical te/s cov]$ "u ! te*nology c]tification w con=m to ! applicable quality requirem5ts ( section #ehg,k ) respect to-- 7i7 design controls1 includ+ relat$ pur*as+ controls & acceptance activities2 7ii7 compla9t inve/igation1 adv]se ev5t report+1 & corrections & removals2 & 7iii7 process validation1 z applicable2 7,g7 proc$ures = analytical & cl9ical validation1 includ+ all proc$ures = validation1 v]ification1 & acceptance crit]ia1 & an explanation z to h[ su* proc$ures1 :5 us$1 provide a %[+ t eligible 9 vitro cl9ical te/s )9 ! propos$ scope ( ! te*nology c]tification ord] are analytically & cl9ically valid2 7,h7 proc$ures t provide a %[+ t 9 vitro cl9ical te/s cov]$ by ! propos$ scope ( ! te*nology c]tification ord] w be safe = individuals :o come into contact ) 9 vitro cl9ical te/s cov]$ by su* ord]2 7,i7 a propos$ li/+ submission "u section #ehg;,j7b7 = 9 vitro cl9ical te/s t ! develop] int5ds to introduce into int]/ate comm]ce ^u receiv+ a te*nology c]tification ord]1 :i* %all n be con/ru$ to limit ! develop] f introduc+ additional te/s n includ$ 9 su* submission "u ! same te*nology c]tification ord]2 7,j7 in=mation conc]n+ "o or m repres5tative 9 vitro cl9ical te/s1 includ+-- 7i7 a te/ )9 ! scope ( ! te*nology c]tification application ) ! appropriate analytical complexity at ! "t ( ! submission ( ! application "u ?is section to s]ve z ! repres5tative te/2 7ii7 ! in=mation specifi$ 9 subsection 7a7 or 7b7 ( section #ehg;,b1 z applicable1 = ! repres5tative 9 vitro cl9ical te/ or te/s1 unless ! ,secret>y det]m9es t su* in=mation is n necess>y2 7iii7 a summ>y ( a risk assessm5t ( ! 9 vitro cl9ical te/2 7iv7 an explanation ( ! *oice ( ! repres5tative 9 vitro cl9ical te/ or te/s = ! te*nology c]tification application & h[ su* te/ adequately demon/rates ! range ( proc$ures t ! develop] includes 9 ! application "u subp>agraphs 7,f71 7,g71 7,h71 & 7,i72 & 7v7 a brief explanation ( ! ways 9 :i* ! proc$ures includ$ 9 ! application "u subp>agraphs 7,f71 7,g71 7,h71 & 7,i7 h be5 appli$ to ! repres5tative 9 vitro cl9ical te/ or te/s2 & 7,k7 su* o!r in=mation necess>y to make a det]m9ation on a te*nology c]tification application z ! ,secret>y may det]m9e necess>y4 7#c7 ,ref]5ce to exi/+ applications ,) respect to ! cont5t requirem5ts 9 ! te*nology c]tification application describ$ 9 p>agraph 7#b71 a develop] may incorporate by ref]5ce any cont5t ( an application previ\sly submitt$ by ! develop]4 7d7 ,action on an application = te*nology c]tification 7#a7 ,secret>y response 7,a7 ,9 g5]al ,z promptly z practicable1 & n lat] ?an #ij days aft] receipt ( an application "u subsection 7c71 ! ,secret>y %all-- 7i7 if ! ,secret>y f9ds t all ( ! gr\nds 9 p>agraph 7#c7 are met1 issue a te*nology c]tification ord] grant+ ! application1 :i*-- 7,i7 may include reasonable conditions ( c]tification2 & 7,,ii7 %all specify ! scope ( ! te*nology c]tification2 or 7ii7 d5y ! application1 if ! ,secret>y f9ds 7& sets =? ! basis ( su* f9d+ z "p ( or accompany+ su* d5ial7 t "o or m gr\nds = grant+ ! application specifi$ 9 p>agraph 7#c7 are n met4 7,b7 ,ext5sion ,! timel9e describ$ 9 subp>agraph 7,a7 may be ext5d$ by mutual agreem5t betwe5 ! ,secret>y & ! applicant4 7#b7 ,defici5t applications 7,a7 ,9 g5]al ,if1 aft] receipt ( an application "u ?is section1 ! ,secret>y det]m9es t any portion ( su* application is defici5t1 ! ,secret>y1 n lat] ?an #fj days aft] receipt ( su* application1 %all provide to ! applicant a description ( su* defici5cies & id5tify ! in=mation requir$ to resolve su* defici5cies4 7,b7 ,conv]t+ to prem>ket applications ,:5 respond+ to ! defici5cy lett]1 ! develop] may conv]t ! application = te*nology c]tification "u subsection 7c7 into a prem>ket application "u section #ehg;,b4 7#c7 ,te*nology c]tification ord] ,! ,secret>y %all issue an ord] grant+ a te*nology c]tification "u ?is section if1 on ! basis ( ! in=mation submitt$ to ! ,secret>y z "p ( ! application & any o!r in=mation ) respect to su* applicant1 ! ,secret>y f9ds t-- 7,a7 !re is a %[+ t 9 vitro cl9ical te/s )9 ! scope ( ! te*nology c]tification ord] w meet ! applicable /&>d2 7,b7 ! me?ods us$ 91 & ! facilities or controls us$ =1 ! developm5t ( eligible 9 vitro cl9ical te/s cov]$ by ! propos$ scope ( ! te*nology c]tification con=m to ! applicable requirem5ts ( section #ehg,k ) respect to-- 7i7 design controls1 includ+ relat$ pur*as+ controls & acceptance activities2 7ii7 compla9t inve/igation1 adv]se ev5t report+1 & corrections & removals2 & 7iii7 process validation1 z applicable2 7,c7 bas$ on a fair evaluation ( all mat]ial facts1 ! applicant's propos$ label+ & adv]tis+ are n false or mislead+ 9 any p>ticul>2 7,d7 ! application does n conta9 a false /atem5t ( mat]ial fact2 7,e7 !re is a %[+ t ! repres5tative 9 vitro cl9ical te/ or te/s-- 7i7 meet ! applicable /&>d2 & 7ii7 reasonably repres5t ! range ( proc$ures requir$ to be submitt$ 9 ! application2 7,f7 ! applicant has agre$ to p]mit1 ^u reque/1 au?oriz$ employees ( ! ,food & ,drug ,adm9i/ration or p]sons accr$it$1 or recogniz$ "u ?is ,act1 an opportunity to inspect at a reasonable "t & 9 a reasonable mann] ! facilities & all p]t95t equipm5t1 f9i%$ & unf9i%$ mat]ials1 conta9]s1 & label+ !re91 includ+ all ?+s 7includ+ records1 files1 pap]s1 & controls7 be>+ on :e!r an 9 vitro cl9ical te/ is adult]at$1 misbr&$1 or o!rwise 9 violation ( ?is ,act1 & p]mits su* au?oriz$ employees or p]sons accr$it$ "u ?is ,act to view & to copy & v]ify all records p]t95t to ! application & ! 9 vitro cl9ical te/2 & 7,g7 bas$ on o!r data & in=mation ! ,secret>y may require "u subsection 7c77#b77,k71 ! ,secret>y f9ds t su* data & in=mation support grant+ a te*nology c]tification ord]4 7#d7 ,review ( d5ials ,an applicant ^: application has be5 d5i$ "u ?is subsection may obta9 review ( su* d5ial "u section #ehg,p4 7e7 ,supplem5ts 7#a7 ,supplem5tal applications 7,a7 ,9 g5]al ,) respect to any ( ! foll[+ *anges relat$ to a te*nology c]tification ord]1 a supplem5tal application to a te*nology c]tification ord] %all be submitt$ by ! hold] ( ! te*nology c]tification ord] describ+ su* propos$ *anges1 & ! 9 vitro cl9ical te/ ) su* *anges may n be introduc$ into int]/ate comm]ce until a te*nology c]tification ord] = su* supplem5tal application is grant$3 7i7 ,any significant *ange to ! proc$ures provid$ 9 support ( ! application = te*nology c]tification submitt$ "u subp>agraph 7,g7 or 7,h7 ( subsection 7c77#b74 7ii7 ,any significant *ange to ! proc$ures provid$ 9 support ( ! application = te*nology c]tification submitt$ "u subp>agraph 7,f7 ( subsection 7c77#b74 7,b7 ,secret>y action on supplem5tal applications ,any action by ! ,secret>y on a supplem5tal application %all be 9 accordance ) subsection 7d71 & any ord] result+ f su* supplem5t %all be treat$ z an am5dm5t to a te*nology c]tification ord]4 7#b7 ,cont5t ( application 7,a7 ,9 g5]al ,a supplem5tal application = a *ange to an 9 vitro cl9ical te/ "u a te*nology c]tification ord] %all-- 7i7 conta9 all necess>y in=mation to make a %[+ t any 9 vitro cl9ical te/ affect$ by su* *ange t is )9 ! scope ( ! te*nology c]tification ord] w meet ! applicable /&>d2 & 7ii7 be limit$ to su* in=mation t is ne$$ to support ! *ange4 7,b7 ,cont5t ,unless o!rwise specifi$ by ! ,secret>y1 a supplem5tal application "u ?is subsection %all include-- 7i7 a description ( ! *ange1 includ+ a rationale = implem5t+ su* *ange2 7ii7 a description ( h[ ! *ange 0 evaluat$2 7iii7 data f a repres5tative 9 vitro cl9ical te/ or te/s t supports a %[+ t1 9 us+ ! modifi$ proc$ure or proc$ures1 all eligible 9 vitro cl9ical te/s )9 ! scope ( ! te*nology c]tification w meet ! applicable /&>d2 7iv7 z applicable1 in=mation to demon/rate t ! modifi$ proc$ure or proc$ures submitt$ "u subsection 7c77#b77;,f7 cont9ue to con=m to applicable requirem5ts "u section #ehg,k2 & 7v7 any o!r in=mation reque/$ by ! ,secret>y4 7#c7 ,*anges 9 response to a public heal? risk 7,a7 ,9 g5]al ,if ! hold] ( a te*nology c]tification makes a *ange to an 9 vitro cl9ical te/ or te/s to address a pot5tial risk to public heal? by add+ a new specification or te/ me?od1 su* hold] may imm$iately implem5t su* *ange & %all submit a notification = su* *ange to ! ,secret>y )9 #cj days4 7,b7 ,cont5t ,any notification to ! ,secret>y "u ?is p>agraph %all include-- 7i7 a summ>y ( ! relevant *ange2 7ii7 ! rationale = implem5t+ su* *ange2 7iii7 7,i7 if su* a *ange necessitates a *ange to ! proc$ures review$ z "p ( ! grant$ te*nology c]tification ord]1 ! modifi$ proc$ures2 or 7,,ii7 if ! proc$ures 7 n *ang$1 an explanation z to :y !y 7 n *ang$2 & 7iv7 if su* a *ange necessitates a *ange to ! proc$ures review$ z "p ( ! grant$ te*nology c]tification ord]1 data f a repres5tative 9 vitro cl9ical te/ or te/s t support a %[+ t1 9 us+ ! modifi$ proc$ures1 all eligible 9 vitro cl9ical te/s )9 ! scope ( ! te*nology c]tification w meet ! applicable /&>d4 7f7 ,tempor>y hold 7#a7 ,9 g5]al ,subject to ! process specifi$ 9 p>agraph 7#b71 & bas$ on "o or m f9d+s "u p>agraph 7#d71 ! ,secret>y may issue a tempor>y hold prohibit+ any hold] ( a te*nology c]tification ord] issu$ "u ?is section f introduc+ into int]/ate comm]ce an 9 vitro cl9ical te/ t 0 n previ\sly ! subject ( a li/+ "u section #ehg;,j4 ,! tempor>y hold %all id5tify ! gr\nds = ! tempor>y hold "u p>agraph 7#d7 & ! rationale = su* f9d+4 7#b7 ,process = issu+ a tempor>y hold ,if ! ,secret>y makes a f9d+ t a tempor>y hold may be w>rant$ bas$ on "o or m gr\nds specifi$ 9 p>agraph 7#d71 ! ,secret>y %all promptly notify ! hold] ( ! te*nology c]tification ord] ( su* f9d+ & provide #cj cal5d> days = ! develop] to come into compliance ) or o!rwise resolve ! f9d+4 7#c7 ,writt5 reque/s ,any writt5 reque/ to ! ,secret>y f ! hold] ( a te*nology c]tification ord] t a tempor>y hold "u p>agraph 7#a7 be remov$ %all receive a decision1 9 writ+ & specify+ ! reasons !re=e1 )9 #ij days aft] receipt ( su* reque/4 ,any su* reque/ %all include in=mation to support ! removal ( ! tempor>y hold4 7#d7 ,gr\nds = tempor>y hold ,! ,secret>y may initiate a tempor>y hold "u ?is subsection ^u a f9d+ t ! hold] ( a te*nology c]tification ord]-- 7,a7 is n 9 compliance ) ! conditions ( ! te*nology c]tification ord] pursuant to subsection 7b77#a77;,d72 7,b7 (f]s "o or m 9 vitro cl9ical te/s ) adv]tis+ or label+ t is false or mislead+2 7,c7 has report$ a correction or removal ( an 9 vitro cl9ical te/ t is (f]$ "u a te*nology c]tification ord] "u ?is section & has fail$ to demon/rate t ! issue or issues caus+ ! correction or removal does n adv]sely impact ! ability ( o!r 9 vitro cl9ical te/s (f]$ "u ! same te*nology c]tification ord] to meet ! applicable /&>d2 or 7,d7 has introduc$ into int]/ate comm]ce an 9 vitro cl9ical te/ "u a te*nology c]tification ord] & su* te/ is adult]at$ or misbr&$1 bas$ on a det]m9ation by ! ,secret>y1 & has fail$ to demon/rate t ! issue or issues caus+ ! adult]ation or misbr&+ does n adv]sely impact ! ability ( o!r 9 vitro cl9ical te/s (f]$ "u ! same te*nology c]tification grant$ "u ?is section to meet ! applicable /&>d4 7g7 ,)drawal ,! ,secret>y may1 aft] due notice & opportunity = an in=mal he>+1 issue an ord] )draw+ a te*nology c]tification ord] includ+ all te/s introduc$ into int]/ate comm]ce "u ! te*nology c]tification ord] if ! ,secret>y f9ds t-- 7#a7 ! application1 supplem5t1 or report "u subsection 7h7 conta9s false or mislead+ in=mation or fails to reveal a mat]ial fact2 7#b7 su* hold] fails to correct false or mislead+ label+ or adv]tis+ ^u ! reque/ ( ! ,secret>y2 7#c7 9 connection ) a te*nology c]tification1 ! hold] provides false or mislead+ in=mation to ! ,secret>y2 or 7#d7 ! hold] ( su* te*nology c]tification ord] fails to correct ! gr\nds = a tempor>y hold )9 a timeframe specifi$ 9 ! tempor>y hold ord]4 7h7 ,reports to ,congress 7#a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! effective date ( ! ,,valid ,act ( #bjbc1 & annually !reaft] = ! next #d ye>s1 ! ,secret>y %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 & make publicly available1 includ+ ?r\gh po/+ on ! website ( ! ,food & ,drug ,adm9i/ration1 a report conta9+ ! in=mation describ$ 9 p>agraph 7#b74 7#b7 ,cont5t 7,a7 ,9 g5]al ,ea* report "u p>agraph 7#a7 %all address1 at a m9imum-- 7i7 ! total numb] ( applications = te*nology c]tifications fil$1 issu$1 )drawn1 & d5i$2 7ii7 ! total numb] ( te*nology c]tification ord]s ! ,secret>y put on tempor>y hold "u subsection 7h7 & ! numb] ( te*nology c]tification ord]s )drawn "u subsection 7i72 7iii7 ! types ( te*nologies = :i* ! ,secret>y issu$ te*nology c]tification ord]s2 7iv7 ! total numb] ( hold]s ( te*nology c]tification ord]s t are 9 effect2 & 7v7 ! total numb] ( 9 vitro cl9ical te/ categories t requir$ prem>ket review "u section #ehg;,b t 7 r$esignat$ z eligible 9 vitro cl9ical te/s "u ?is section4 7,b7 ,f9al report ,! fif? report submitt$ "u p>agraph 7#a7 %all include a summ>y (1 & responses to1 comm5ts rais$ 9 ! docket4 7,c7 ,p]=mance reports ,! reports requir$ "u ?is section may be issu$ ) p]=mance reports z requir$ "u section #i ( ! ,,valid ,act ( #bjbc4 7i7 ,public meet+ & input 7#a7 ,public docket ,n lat] ?an #cj days aft] ! date ( enactm5t ( ! ,,valid ,act ( #bjbc1 ! ,secret>y %all e/abli% a public docket to receive comm5ts conc]n+ recomm5dations = implem5tation ( ?is section1 includ+ crit]ia & proc$ures = subsections 7c7 ?r\gh 7h74 ,! public docket %all rema9 op5 = at lea/ #a ye> aft] ! e/abli%m5t ( ! public docket4 7#b7 ,public meet+ ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,,valid ,act ( #bjbc1 ! ,secret>y %all conv5e a public meet+ to :i* /akehold]s f organizations repres5t+ pati5ts & consum]s1 academia1 & ! 9 vitro cl9ical te/ indu/ry are invit$ to discuss ! te*nology c]tification process includ+ application requirem5ts1 inspections1 alignm5t ) ?ird-p>ty accr$itors1 & ! def9ition ( ! t]m te*nology "u section #ehg4 7j7 ,regulations ,! ,secret>y %all issue regulations reg>d+ ! te*nology c]tification process1 includ+ describ+ crit]ia or proc$ures relat+ to te*nology c]tification "u ?is section1 :i* %all be subject to public comm5t = a m9imum ( #fj days f issuance prior to f9aliz+ su* regulations aft] consid]+ ! comm5ts receiv$4 ,! regulation %all include an outl9e ( ! application process1 opportunities to meet ) (ficials ( ! ,food & ,drug ,adm9i/ration1 & plans to /reaml9e inspections4 7k7 ,notification 7#a7 ,9 g5]al ,not)/&+ subsection 7a77#a71 a fir/-(-a-k9d 9 vitro cl9ical te/ or a comb9ation product t meets ! def9ition ( a mod]ate-risk te/ "u section #ehg may be introduc$ into int]/ate comm]ce "u a te*nology c]tification ord] t has be5 issu$ by ! ,secret>y1 subject to o!r applicable requirem5ts if-- 7,a7 ! develop] provides notification to ! ,secret>y #fj days prior to introduc+ su* te/s into int]/ate comm]ce t includes in=mation demon/rat+ t ! te/ is mod]ate-risk & )9 ! scope ( ! applicable te*nology c]tification ord]2 & 7,b7 ! ,secret>y has n issu$ a notification to ! develop] "u p>agraph 7#b7 be=e su* "t has elaps$4 7#b7 ,notification f ,secret>y ,! ,secret>y %all issue a notification to ! develop] t su* te/ may n be introduc$ into int]/ate comm]ce "u su* ord] if ! ,secret>y det]m9es t-- 7,a7 su* te/-- 7i7 does n meet ! def9ition ( a mod]ate-risk te/ "u section #ehg2 7ii7 is n eligible to be introduc$ into int]/ate comm]ce "u any ( subp>agraphs 7,a7 ?r\gh 7,e7 ( subsection 7a77#a72 or 7iii7 is n eligible to be introduc$ into int]/ate comm]ce "u ! ref]5c$ te*nology c]tification ord] issu$ by ! ,secret>y because x is n )9 ! scope ( ! te*nology c]tification ord] "u subsection 7b77#b72 or 7,b7 bas$ on ! in=mation includ$ 9 ! notification submitt$ by ! develop] pursuant to ?is subsection1 !re is insuffici5t in=mation = ! ,secret>y to make ! det]m9ations describ$ 9 clauses 7i71 7ii71 & 7iii7 ( subp>agraph 7,a74 #ehg;,e4 ,mitigat+ measures 7a7 ,e/abli%m5t ( mitigat+ measures 7#a7 ,e/abli%+1 *ang+1 or )draw+ 7,a7 ,e/abli%m5t ,! ,secret>y may e/abli% & require1 on ! basis ( evid5ce1 mitigat+ measures = any 9 vitro cl9ical te/ or category ( 9 vitro cl9ical te/s ) ! same indications = use t is introduc$ or deliv]$ = introduction into int]/ate comm]ce aft] ! ,secret>y e/abli%es any su* mitigat+ measures4 7,b7 ,me?ods ( e/abli%m5t ,! ,secret>y may e/abli% mitigat+ measures-- 7i7 "u ! process set =? 9 subp>agraph 7,d72 7ii7 z provid$ "u section #ehg;,f2 or 7iii7 ?r\gh a prem>ket approval or te*nology c]tification ord]1 :i* may e/abli% mitigat+ measures = an individual 9 vitro cl9ical te/ or a category ( 9 vitro cl9ical te/s4 7,c7 ,me?ods ( *ange or )drawal ,! ,secret>y may *ange or )draw mitigat+ measures-- 7i7 "u ! process set =? 9 subp>agraph 7,d72 or 7ii7 z provid$ "u section #ehg;,f4 7,d7 ,process = e/abli%m5t1 *ange1 or )drawal ,not)/&+ sub*apt] ,,ii ( *apt] #e ( title #e1 ,unit$ ,/ates ,code1 ! ,secret>y may1 ^u ! initiative ( ! ,secret>y or ^u petition ( an int]e/$ p]son1 e/abli%1 *ange1 or )draw mitigat+ measures = an 9 vitro cl9ical te/ or category ( 9 vitro cl9ical te/s by-- 7i7 publi%+ a propos$ ord] 9 ! ,f$]al ,regi/]2 7ii7 provid+ an opportunity = public comm5t = a p]iod ( n less ?an #cj #fj cal5d> days2 & 7iii7 aft] consid]ation ( any comm5ts submitt$1 publi%+ a f9al ord] 9 ! ,f$]al ,regi/] t responds to ! comm5ts submitt$1 & :i* %all include a reasonable transition p]iod4 7,e7 ,effect ( mitigat+ measures on gr&fa!r$ te/s ,a mitigat+ measure %all n be requir$ by ! ,secret>y = an 9 vitro cl9ical te/ subject to section #ehg;,g7a74 7#b7 ,9 vitro cl9ical te/s previ\sly cle>$ or exempt z devices ) special controls 7,a7 ,9 g5]al ,any special controls applicable to an 9 vitro cl9ical te/ previ\sly cle>$ or exempt "u section #eaj7k71 or classifi$ "u section #eac7;f77#b7 prior to date ( enactm5t ( ! ,,valid ,act ( #bjbc1 includ+ any su* special controls e/abli%$ dur+ ! p]iod beg9n+ on ! date ( enactm5t ( ! ,,valid ,act ( #bjbc & end+ on ! effective date ( su* ,act 7z describ$ 9 section #e7;b7 ( su* ,act7-- 7i7 %all cont9ue to apply to su* 9 vitro cl9ical te/ aft] su* effective date2 & 7ii7 are deem$ to be mitigat+ measures z ( ! effective date specifi$ 9 section #e7;a77#a77;,a7 ( ! ,,valid ,act ( #bjbc4 7,b7 ,*anges ,not)/&+ subp>agraph 7,a71 ! ,secret>y may e/abli%1 *ange1 or )draw mitigat+ measures = su* te/s or category ( te/s us+ ! proc$ures "u p>agraph 7#a74 7b7 ,docum5tation 7#a7 ,9 vitro cl9ical te/s subject to prem>ket review ,! develop] ( an 9 vitro cl9ical te/ subject to prem>ket review "u section #ehg;,b & to :i* mitigat+ measures apply %all ma9ta9 docum5tation 9 accordance ) ! applicable quality requirem5ts "u section #ehg,k & make su* docum5tation available to ! ,secret>y ^u reque/ or inspection4 7#b7 ,o!r te/s ,! develop] ( an 9 vitro cl9ical te/ t is (f]$ "u a te*nology c]tification ord] or o!r exemption f prem>ket review "u section #ehg;,b & to :i* mitigat+ measures apply %all-- 7,a7 ma9ta9 docum5tation 9 accordance ) ! applicable quality requirem5ts "u section #ehg,k demon/rat+ t su* mitigat+ measures cont9ue to be met foll[+ a te/ modification by ! develop]2 7,b7 make su* docum5tation available to ! ,secret>y ^u reque/ or inspection2 & 7,c7 include 9 ! p]=mance summ>y = su* te/ a brief description ( h[ su* mitigat+ measures are met1 if applicable4 #ehg;,f4 ,regulatory pa?way designation 7a7 ,pa?way det]m9ations 7#a7 ,9 g5]al ,aft] consid]+ available evid5ce ) respect to an 9 vitro cl9ical te/ or category ( 9 vitro cl9ical te/s ) ! same int5d$ use1 includ+ ! id5tification1 e/abli%m5t "u p>agraph 7#d71 & implem5tation ( mitigat+ measures "u section #ehg;,e1 z appropriate1 ! ,secret>y may1 ^u ! initiative ( ! ,secret>y or ^u reque/ ( a develop]1 det]m9e t-- 7,a7 su* 9 vitro cl9ical te/ is high-risk & subject to prem>ket review "u section #ehg;,b2 7,b7 su* 9 vitro cl9ical te/s1 includ+ a fir/-(-a-k9d te/1 is mod]ate-risk & subject to abbreviat$ prem>ket review "u section #ehg;,b7b7 or te*nology c]tification "u section #ehg;,d7a77#a72 or 7,c7 su* 9 vitro cl9ical te/1 includ+ a fir/-(-a-k9d te/ is l[-risk or o!rwise exempt f prem>ket review "u section #ehg;,b4 7#b7 ,reque/s 7,a7 ,submissions by develop]s 7i7 ,abbreviat$ prem>ket review2 te*nology c]tification ,a develop] submitt+ a reque/ t ! ,secret>y make a det]m9ation z describ$ 9 p>agraph 7#a77;,b7 %all submit in=mation to support t ! 9 vitro cl9ical te/ is mod]ate-risk or propose mitigat+ measures1 if applicable1 t w\ld support su* a det]m9ation4 7ii7 ,l[-risk2 exempt f prem>ket review ,a develop] submitt+ a reque/ t ! ,secret>y make a det]m9ation z describ$ 9 p>agraph 7#a77;,c7 %all submit in=mation t ! 9 vitro cl9ical te/ is l[-risk1 or o!rwise appropriate = exemption f prem>ket review "u section #ehg;,b & propose mitigat+ measures1 if applicable1 t w\ld support su* a det]m9ation4 7,b7 ,response by ! ,secret>y ,n lat] ?an #cj days aft] receiv+ a reque/ "u clause 7i7 or 7ii7 ( subp>agraph 7,a71 ! ,secret>y %all provide a timely response describ+ :e!r or n ! ,secret>y w initiate ! process = mak+ a det]m9ation "u p>agraph 7#a77;,b7 or 7#a77;,c7 z describ$ 9 p>agraph 7#d74 7#c7 ,suffici5cy ( mitigat+ measures ,:5 det]m9+ :e!r mitigat+ measures = an 9 vitro cl9ical te/1 or category ( 9 vitro cl9ical te/s1 are suffici5t to make su* te/ mod]ate-risk or l[-risk1 ! ,secret>y %all take into acc\nt ! foll[+3 7,a7 ,! degree to :i* ! te*nology = ! int5d$ use ( ! 9 vitro cl9ical te/ is well-*>act]iz$1 tak+ into consid]ation factors t include "o or m ( ! foll[+3 7i7 ,pe]-review$ lit]ature4 7ii7 ,practice guidel9es4 7iii7 ,cons5sus /&>ds4 7iv7 ,recogniz$ /&>ds ( c>e4 7v7 ,use ( su* te*nology1 includ+ hi/orical use4 7vi7 ,multiple sci5tific publications by diff]5t au?ors4 7vii7 ,adoption by ! sci5tific or cl9ical community4 7viii7 ,real _w evid5ce4 7,b7 ,:e!r ! crit]ia = p]=mance ( ! te/ are well-e/abli%$ to be suffici5t = ! int5d$ use4 7,c7 ,! cl9ical circum/ances "u :i* ! 9 vitro cl9ical te/ is us$1 includ+ :e!r ! 9 vitro cl9ical te/ is ! sole det]m9ate = ! diagnosis or treatm5t ( ! t>get$ disease1 & ! availability ( o!r te/s 7su* z confirmatory or adjunctive te/s7 or relevant mat]ial /&>ds4 7,d7 ,:e!r su* mitigat+ measures suffici5tly mitigate ! risk ( h>m su* t ! te/ or category ( te/s is mod]ate-risk or l[-risk4 7#d7 ,process 7,a7 ,9 g5]al ,= a te/ t is n fir/-(-a-k9d1 any action "u p>agraph 7#a7 %all be made by publication ( a notice ( su* propos$ action on ! website ( ! ,food & ,drug ,adm9i/ration1 ! consid]ation ( comm5ts to a public docket on su* proposal1 & publication ( a f9al action on su* website )9 #fj cal5d> days ( ! close ( ! comm5t p]iod po/$ to su* public docket1 not)/&+ sub*apt] ,,ii ( *apt] #e ( title #e1 ,unit$ ,/ates ,code4 7,b7 ,process = fir/-(-a-k9d te/ ,9 ! case ( an 9 vitro cl9ical te/ t is fir/-(-a-k9d1 ! process is z foll[s3 7i7 ,any det]m9ation t ! te/ is subject to prem>ket approval or abbreviat$ prem>ket review "u subp>agraph 7,a7 or 7,b7 ( p>agraph 7#a7 %all be publi%$ on ! website ( ! ,food & ,drug ,adm9i/ration1 not)/&+ subclause ,,ii ( *apt] #e ( title #e1 ,unit$ ,/ates ,code1 only aft] ! 9 vitro cl9ical te/ is approv$ "u section #ehg;,b4 ,until t "t1 ! det]m9ation %all n be b9d+ on o!r 9 vitro cl9ical te/s4 7ii7 ,any det]m9ation o!r ?an ^? made "u clause 7i7 %all be made by publication ( a notice ( f9al action on ! website ( ! ,food & ,drug ,adm9i/ration1 not)/&+ sub*apt] ,,ii ( *apt] #e ( title #e1 ,unit$ ,/ates ,code4 7#e7 ,no effect on gr&fa!r+ det]m9ations ,a det]m9ation "u p>agraph 7#a7 %all h no effect on ! applicability ( section #ehg;,g to an 9 vitro cl9ical te/s4 7b7 ,transition p]iod ,^u a decision by ! ,secret>y to *ange a regulatory pa?way designation1 or reclassifies an 9 vitro cl9ical te/1 or category ( 9 vitro cl9ical te/s1 ! ,secret>y %all provide an appropriate transition p]iod ) respect to any new requirem5ts4 7c7 ,appeals ,a decision by ! ,secret>y "u ?is section %all be deem$ a significant decision subject to appeal "u section #ehg,p4 7d7 ,advisory committee ,! ,secret>y may reque/ recomm5dations f an advisory committee "u section #ehg;,h pursuant to c>ry+ out ?is section4 7e7 ,reque/ = in=mal fe$back ,be=e submitt+ a prem>ket application or te*nology c]tification application = an 9 vitro cl9ical te/-- 7#a7 ! develop] ( ! te/ may submit to ! ,secret>y a writt5 reque/ = a meet+1 conf]5ce1 or writt5 fe$back to discuss & provide in=mation relat+ to ! regulation ( su* 9 vitro cl9ical te/ :i* may include-- 7,a7 ! submission process & ! type & am\nt ( evid5ce expect$ to demon/rate ! applicable /&>d2 7,b7 :i* regulatory pa?way is appropriate = an 9 vitro cl9ical te/2 & 7,c7 an inve/igation plan = an 9 vitro cl9ical te/1 includ+ a cl9ical protocol2 & 7#b7 ^u receipt ( su* a reque/1 ! ,secret>y %all-- 7,a7 if a meet+ is reque/$-- 7i7 )9 #fj cal5d> days aft] su* receipt1 or )9 su* "t p]iod z may be agre$ to by ! develop]1 meet or conf] ) ! develop] submitt+ ! reque/2 & 7ii7 )9 #ae cal5d> days aft] su* meet+ or conf]5ce1 provide to ! develop] a writt5 record or response describ+ ! issues discuss$ & conclusions rea*$ 9 ! meet+ or conf]5ce2 & 7,b7 if writt5 fe$back is reque/$1 provide fe$back to ! reque/or )9 #ge days aft] su* receipt4 #ehg;,g4 ,gr&fa!r$ 9 vitro cl9ical te/s 7a7 ,9 g5]al ,subject to subsection 7d71 an 9 vitro cl9ical te/ is exempt f ! requirem5ts ( ?is sub*apt] specifi$ 9 subsection 7b7 if-- 7#a7 ! te/ 0 fir/ (f]$ = cl9ical use1 & 0 n int5d$ solely = inve/igational use1 n lat] ?an #de days aft] ! date ( enactm5t ( ! ,,valid ,act ( #bjbc2 7#b7 ! te/ 0 develop$ by a cl9ical laboratory = :i* a c]tificate 0 9 effect "u section #cec ( ! ,public ,heal? ,s]vice ,act t meets ! requirem5ts = p]=m+ te/s ( high complexity2 7#c7 ! te/ is p]=m$-- 7,a7 9 ! same cl9ical laboratory 9 :i* ! te/ 0 develop$ = :i* a c]tification is /ill 9 effect "u section #cec ( ! ,public ,heal? ,s]vice ,act t meets ! requirem5ts to p]=m te/s ( high complexity2 7,b7 by ano!r cl9ical laboratory = :i* a c]tificate is 9 effect "u section #cec ( su* ,act t meets ! requirem5ts to p]=m te/s ( high complexity1 & t is )9 ! same corporate organization & hav+ common own]%ip by ! same p>5t corporation z ! laboratory 9 :i* ! te/ 0 develop$2 or 7,c7 9 ! case ( a te/ t 0 develop$ by ! ,c5t]s = ,disease ,control & ,prev5tion or ano!r laboratory 9 a public heal? laboratory network coord9at$ or manag$ by ! ,c5t]s = ,disease ,control & ,prev5tion1 by a cl9ical laboratory = :i* a c]tificate is 9 effect "u section #cec ( su* ,act t meets ! requirem5ts to p]=m te/s ( high complexity1 & t is )9 a public heal? laboratory network coord9at$ or manag$ by ! ,c5t]s = ,disease ,control & ,prev5tion2 7#d7 ! te/ does n h 9 effect an approval "u section #eae1 a cle>ance "u section #eaj7k71 an au?orization "u section #eac7;f77#b71 or an exemption "u section #ebj7m71 or lic5sure "u section #cea ( ! ,public ,heal? ,s]vice ,act2 7#e7 any modification to ! te/ on or aft] ! date t is #de days aft] ! date ( enactm5t ( ! ,,valid ,act ( #bjbc is made by ! initial develop]1 con=ms ) section #ehg;,c7a77#f77;,a77ii71 & does n meet ! crit]ia 9 subsection 7d77#a72 7#f7 :5 us$ z an inve/igational 9 vitro cl9ical te/1 su* te/ complies ) section #ehg,s1 z applicable2 7#g7 ! te/ is (f]$ ) an ord] f an au?oriz$ p]son z requir$ "u section #cec ( ! ,public ,heal? ,s]vice ,act1 & 0 (f]$ ) a prescription requir$ "u section #hji4cj7;f7 ( title #ba1 ,code ( ,f$]al ,regulations prior to ! effective date ( ?is sub*apt]2 7#h7 ! te/ is n = use ) home specim5 collection1 unless ! specim5 is collect$ ) a collection conta9]1 receptacle1 or kit t-- 7,a7 has be5 approv$1 cle>$1 or au?oriz$ by ! ,secret>y = home specim5 collection & ! collection is p]=m$ pursuant to ! approv$1 cle>$1 or au?oriz$ label+1 includ+ any indication = use z prescription use or ov]-!-c\nt] use1 or 7,b7 is exempt f prem>ket review & its use is consi/5t ) applicable limitations on ! exemption2 7#i7 ! te/ is n a specim5 receptacle or in/rum5t2 7#aj7 ea* te/ report = ! te/ be>s a /atem5t t reads z foll[s3 ,?is 9 vitro cl9ical te/ 0 introduc$ into comm]ce prior to ! application ( ! ,,valid ,act & is exempt f ,,fda prem>ket review42 & 7#aa7 ! develop] ( ! te/-- 7,a7 ma9ta9s docum5tation demon/rat+ t ! te/ meets & cont9ues to meet ! crit]ia set =? 9 ?is subsection2 & 7,b7 makes su* docum5tation available to ! ,secret>y ^u reque/4 7b7 ,exemptions applicable to gr&fa!r$ te/s ,an 9 vitro cl9ical te/ t meets ! crit]ia specifi$ 9 subsection 7a7 is exempt f prem>ket review "u #ehg;,b1 label+ requirem5ts "u #ehg,l1 & te/ design requirem5ts & quality requirem5ts "u #ehg,k1 & may be lawfully (f]$ subject to ! o!r applicable requirem5ts ( ?is ,act4 7c7 ,modifications ,9 ! case ( an 9 vitro cl9ical te/ t meets ! crit]ia specifi$ 9 subsection 7a71 su* te/ cont9ues to qualify = ! exemptions describ$ 9 subsection 7b7 if ! te/ is modifi$ & ! modification is ( a type describ$ 9 subsection 7a77#e71 & ! p]son modify+ su* 9 vitro cl9ical te/-- 7#a7 docum5ts ea* su* modification & ma9ta9s docum5tation ( ! basis = su* det]m9ation2 7#b7 provides su* docum5tation relat+ to ! *ange to ! ,secret>y ^u reque/ or inspection2 & 7#c7 does n modify ! 9 vitro cl9ical te/ su* t x no long] meets ! crit]ia "u subsection 7a74 7d7 ,reque/ = in=mation 7#a7 ,crit]ia ,! crit]ia describ$ 9 ?is p>agraph are any ( ! foll[+3 7,a7 ,!re is a lack ( valid sci5tific evid5ce to support t ! 9 vitro cl9ical te/ is analytically valid or cl9ically valid4 7,b7 ,su* 9 vitro cl9ical te/ is be+ (f]$ by its develop] ) any false or mislead+ analytical or cl9ical claims4 7,c7 ,x is probable t su* 9 vitro cl9ical te/ w cause s]i\s adv]se heal? consequ5ces4 7#b7 ,process 7,a7 ,writt5 reque/ = in=mation ,! ,secret>y may issue a writt5 reque/ to a develop] id5tify+ specific sci5tific conc]ns1 bas$ on cr$ible in=mation1 ) an 9 vitro cl9ical te/1 :i* indicate t "o or m ( ! crit]ia describ$ 9 p>agraph 7#a7 apply to su* 9 vitro cl9ical te/4 ,su* writt5 reque/ %all include specific in=mation reque/s p]ta9+ to su* crit]ia4 7,b7 ,deadl9e = submitt+ in=mation ,n lat] ?an #de days aft] receiv+ a reque/ = in=mation "u subp>agraph 7,a7-- 7i7 ! develop] ( an 9 vitro cl9ical te/-- 7,i7 may seek a teleconf]5ce prior to ! submission ( in=mation "u subclause 7,,ii7 to discuss ! ,secret>y's reque/2 & 7,,ii7 %all submit ! in=mation reque/$ pursuant to subp>agraph 7,a71 & may include 9 su* submission a reque/ = a teleconf]5ce2 & 7ii7 ! ,secret>y %all-- 7,i7 s*$ule a teleconf]5ce reque/$ "u clause 7i77,i72 & 7,,ii7 hold a teleconf]5ce if reque/$ )9 #aj days ( ! ,secret>y's receipt ( ! in=mation submitt$ "u clause 7i77,,ii74 7,c7 ,review deadl9e ,^u receiv+ a submission "u subp>agraph 7,b71 ! ,secret>y %all-- 7i7 review ! submitt$ in=mation )9 #de cal5d> days ( su* receipt1 :i* may include communication ) ! develop]2 & 7ii7 det]m9e :e!r ! crit]ia li/$ 9 p>agraph 7#a7 apply to ! 9 vitro cl9ical te/ & communicate su* det]m9ation to ! develop] z describ$ 9 subp>agraph 7,d74 7,d7 ,communication & results ( det]m9ation ,! ,secret>y %all notify ! develop]1 9 writ+1 ( ! ,secret>y's det]m9ation "u subp>agraph 7,c71 z foll[s3 7i7 ,if ! ,secret>y det]m9es t none ( ! crit]ia li/$ 9 p>agraph 7#a7 apply to ! 9 vitro cl9ical te/1 su* te/ %all be exempt f relevant requirem5ts ( ?is sub*apt]1 z set =? 9 subsection 7b71 subject to ! crit]ia "u subsection 7a74 7ii7 ,if ! ,secret>y det]m9es t "o or m ( ! crit]ia li/$ 9 p>agraph 7#a7 apply to ! te/ b su* a det]m9ation may be resolv$ )9 a reasonable "t1 & ! te/ has n be5 previ\sly subject to ?is subsection on ! basis ( ! same or sub/antially simil> sci5tific conc]ns id5tifi$ 9 ! writt5 reque/ issu$ "u p>agraph 7d77#b77;,a7-- 7,i7 ! ,secret>y %all notify ! develop] ( su* a det]m9ation & all[ ! develop] to seek a teleconf]5ce to discuss ! f9d+2 7,,ii7 ! develop] %all submit in=mation demon/rat+ resolution ( ! det]m9ation )9 #ae days ( receiv+ su* notification2 & 7,,iii7 ! ,secret>y %all make a det]m9ation )9 #cj days ( ! receipt ( su* submission ( in=mation z to :e!r ! crit]ia "u p>agraph 7#a7 cont9ue to apply to ! te/ &1 if ?r\gh su* det]m9ation ! ,secret>y det]m9es t-- 7aa7 none ( ! crit]ia li/$ 9 p>agraph 7#a7 apply to ! te/1 su* te/ %all be exempt f relevant requirem5ts ( ! sub*apt] z set =? 9 subsection 7b71 subject to applicable limitations2 or 7bb7 "o or m ( ! crit]ia li/$ 9 p>agraph 7#a7 apply to ! 9 vitro cl9ical te/1 su* te/ is n exempt z set =? 9 ?is section & %all n be (f]$ unless approv$ "u section #ehg;,b1 or1 ^u a det]m9ation by ! ,secret>y pursuant to section #ehg;,f1 (f]$ "u a te*nology c]tification ord] "u section #ehg;,d or (f]$ z a l[-risk te/4 7iii7 ,if ! ,secret>y det]m9es t "o or m ( ! crit]ia li/$ 9 p>agraph 7#a7 apply to ! 9 vitro cl9ical te/ & clause 7ii7 does n apply1 ! 9 vitro cl9ical te/ is n exempt z set =? 9 ?is section & %all n be (f]$ unless approv$ "u section #ehg;,b1 or ^u a det]m9ation by ! ,secret>y pursuant to section #ehg;,f1 (f]$ "u a te*nology c]tification ord] "u section #ehg;,d or (f]$ z a l[-risk te/4 #ehg;,h4 ,advisory committees 7a7 ,9 g5]al ,! ,secret>y may e/abli% advisory committees or use advisory committee panels ( exp]ts e/abli%$ be=e ! date ( enactm5t ( ! ,,valid ,act ( #bjbc 7includ+ a device classification panel "u section #eac7 = ! purposes ( provid+ exp]t sci5tific advice & mak+ recomm5dations relat$ to-- 7#a7 ! approval ( an application = an 9 vitro cl9ical te/ submitt$ "u ?is sub*apt]1 includ+ = evaluat+1 z applicable1 ! analytical validity1 cl9ical validity1 & safety ( 9 vitro cl9ical te/s2 7#b7 ! pot5tial effectiv5ess ( mitigat+ measures = a det]m9ation ( ! applicable regulatory pa?way "u section #ehg;,f7b7 or risk evaluation = an 9 vitro cl9ical te/ or te/s2 7#c7 quality requirem5ts "u section #ehg,k or apply+ su* requirem5ts to 9 vitro cl9ical te/s develop$ or import$ by develop]s2 7#d7 appeals "u section #ehg,p2 or 7#e7 su* o!r purposes z ! ,secret>y det]m9es appropriate4 7b7 ,appo9tm5ts 7#a7 ,vot+ memb]s ,! ,secret>y %all appo9t to ea* committee e/abli%$ "u subsection 7a71 z vot+ memb]s1 individuals :o are qualifi$ by tra9+ & exp]i5ce to evaluate 9 vitro cl9ical te/s ref]r$ to ! committee = ! purposes specifi$ 9 subsection 7a71 includ+ individuals )1 to ! ext5t feasible1 sci5tific exp]tise 9 ! developm5t ( su* 9 vitro cl9ical te/s1 laboratory op]ations1 & ! use ( 9 vitro cl9ical te/s4 ,! ,secret>y %all designate "o memb] ( ea* committee to s]ve z *air4 7#b7 ,nonvot+ memb]s ,9 addition to ! individuals appo9t$ pursuant to p>agraph 7#a71 ! ,secret>y %all appo9t to ea* committee e/abli%$ "u subsection 7a71 z nonvot+ memb]s-- 7,a7 a repres5tative ( consum] int]e/s2 & 7,b7 a repres5tative ( int]e/s ( 9 vitro cl9ical te/ develop]s n directly affect$ by ! matt] to be br\ght be=e ! committee4 7#c7 ,limitation ,no individual :o is a regul> full-"t employee ( ! ,unit$ ,/ates & engag$ 9 ! adm9i/ration ( ?is ,act may be a memb] ( any advisory committee e/abli%$ "u subsection 7a74 7#d7 ,education & tra9+ ,! ,secret>y %all1 z appropriate1 provide education & tra9+ to ea* new committee memb] be=e su* memb] p>ticipates 9 a committee's activities1 includ+ education reg>d+ requirem5ts "u ?is ,act & relat$ regulations ( ! ,secret>y1 & ! adm9i/rative processes & proc$ures relat$ to committee meet+s4 7#e7 ,meet+s ,! ,secret>y %all ensure t sci5tific advisory committees meet regul>ly & at appropriate int]vals s t any matt] to be review$ by su* a committee c be pres5t$ to ! committee n m ?an #fj cal5d> days aft] ! matt] is ready = su* review4 ,meet+s ( ! committee may be held us+ electronic or telephonic communication to conv5e ! meet+s4 7#f7 ,comp5sation ,memb]s ( an advisory committee e/abli%$ "u subsection 7a71 :ile att5d+ meet+s or conf]5ces or o!rwise engag$ 9 ! bus9ess ( ! advisory committee-- 7,a7 %all be entitl$ to receive comp5sation at rates to be fix$ by ! ,secret>y1 b n to exce$ ! daily equival5t ( ! rate 9 effect = positions classifi$ above level ,,gs-#ae ( ! ,g5]al ,s*$ule2 & 7,b7 may be all[$ travel exp5ses z au?oriz$ by section #egjc ( title #e1 ,unit$ ,/ates ,code1 = employees s]v+ int]mitt5tly 9 ! ,gov]nm5t s]vice4 7c7 ,guidance ,! ,secret>y may issue guidance on ! policies & proc$ures gov]n+ advisory committees e/abli%$ "u subsection 7a74 #ehg;,i4 ,break?r\gh 9 vitro cl9ical te/s 7a7 ,9 g5]al ,! purpose ( ?is section is to enc\rage ! ,secret>y1 & provide ! ,secret>y ) suffici5t au?ority1 to apply effici5t & flexible approa*es to exp$ite ! developm5t (1 & prioritize ! review (1 9 vitro cl9ical te/s t repres5t break?r\gh te*nologies4 7b7 ,e/abli%m5t ( program ,! ,secret>y %all e/abli% a program to exp$ite ! developm5t (1 & provide = ! priority review (1 9 vitro cl9ical te/s4 7c7 ,eligibility ,! program develop$ "u subsection 7b7 %all be available = any 9 vitro cl9ical te/ t-- 7#a7 provides or enables m effective treatm5t or diagnosis ( life-?reat5+ or irrev]sibly debilitat+ human disease or conditions2 & 7#b7 is a te/-- 7,a7 t repres5ts a break?r\gh te*nology2 7,b7 = :i* no approv$ alt]native 9 vitro cl9ical te/ exi/s1 includ+ no 9 vitro cl9ical te/ (f]$ "u a te*nology c]tification ord]2 7,c7 t (f]s a cl9ically mean+ful advantage ov] exi/+ alt]native 9 vitro cl9ical te/s t are approv$ 7includ+ 9 vitro cl9ical te/s (f]$ "u a te*nology c]tification ord]71 includ+ ! pot5tial to r$uce or elim9ate ! ne$ = hospitalization1 improve pati5t quality ( life1 facilitate pati5ts' ability to manage _! own c>e 7su* z ?r\gh self-direct$ p]sonal assi/ance71 or e/abli% long-t]m cl9ical effici5cies2 or 7,d7 ! availability ( :i* is 9 ! be/ int]e/ ( pati5ts or public heal?4 7d7 ,designation 7#a7 ,reque/ ,to receive break?r\gh designation "u ?is section1 an applicant may reque/ t ! ,secret>y designate ! 9 vitro cl9ical te/ = exp$it$ developm5t & priority review4 ,any su* reque/ = designation may be made at any "t prior to1 or at ! "t (1 ! submission ( an application "u section #ehg;,b or #ehg;,d1 & %all include in=mation demon/rat+ t ! te/ meets ! crit]ia describ$ 9 subsection 7c74 7#b7 ,det]m9ation ,n lat] ?an #fj cal5d> days aft] ! receipt ( a reque/ "u p>agraph 7#a71 ! ,secret>y %all det]m9e :e!r ! 9 vitro cl9ical te/ t is ! subject ( ! reque/ meets ! crit]ia describ$ 9 subsection 7c74 ,if ! ,secret>y det]m9es t ! te/ meets ! crit]ia1 ! ,secret>y %all designate ! te/ = exp$it$ developm5t & priority review4 7#c7 ,review ,review ( a reque/ "u p>agraph 7#a7 %all be und]tak5 by a team t is compos$ ( exp]i5c$ /aff & s5ior manag]s ( ! ,food & ,drug ,adm9i/ration4 7#d7 ,)drawal 7,a7 ,9 g5]al ,! designation ( an 9 vitro cl9ical te/ "u ?is subsection is deem$ to be )drawn1 & su* 9 vitro cl9ical te/ %all no long] be eligible = designation "u ?is section1 if an application = approval = su* te/ "u section #ehg;,b or #ehg;,d is d5i$4 ,su* te/ %all be eligible = break?r\gh designation ^u a new reque/ = su* designation4 7,b7 ,exception ,! ,secret>y may n )draw a designation grant$ "u ?is subsection bas$ on ! subsequ5t approval or te*nology c]tification ( ano!r 9 vitro cl9ical te/ t-- 7i7 is designat$ "u ?is section2 or 7ii7 0 giv5 priority review "u section #eae;,b4 7e7 ,actions ,= purposes ( exp$it+ ! developm5t & review ( 9 vitro cl9ical te/s "u ?is section1 ! ,secret>y may take ! actions & additional actions set =? 9 p>agraphs 7#a7 & 7#b71 respectively1 ( section #eae;,b7e7 :5 review+ su* te/s4 ,any ref]5ce or au?orization 9 section #eae;,b7e7 ) respect to a device %all be deem$ a ref]5ce or au?orization ) respect to an 9 vitro cl9ical te/ = purposes ( ?is section4 7f7 ,guidance ,n lat] ?an #cj mon?s aft] ! date ( enactm5t ( ! ,,valid ,act ( #bjbc1 ! ,secret>y %all issue f9al guidance on ! implem5tation ( ?is section4 ,su* guidance %all-- 7#a7 set =? ! process by :i* a p]son may seek a designation "u subsection 7d72 7#b7 provide a template = reque/ "u subsection 7d72 7#c7 id5tify ! crit]ia ! ,secret>y w use 9 evaluat+ a reque/ = designation2 & 7#d7 id5tify ! crit]ia & processes ! ,secret>y w use to assign a team ( /aff1 includ+ team lead]s1 to review 9 vitro cl9ical te/s designat$ = exp$it$ developm5t & priority review1 includ+ any tra9+ requir$ = su* p]sonnel to ensure effective & effici5t review4 7g7 ,rules ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to affect-- 7#a7 ! crit]ia & /&>ds = evaluat+ an application pursuant to section #ehg;,b or #ehg;,d1 includ+ ! recognition ( valid sci5tific evid5ce z describ$ 9 section #ehg7bj7 & consid]ation & application ( ! lea/ burd5some means describ$ "u section #ehg;,,aa7c72 7#b7 ! au?ority ( ! ,secret>y ) respect to cl9ical holds "u section #ehg,s2 7#c7 ! au?ority ( ! ,secret>y to act on an application pursuant to section #ehg;,b be=e completion ( an e/abli%m5t inspection1 z ! ,secret>y det]m9es appropriate2 or 7#d7 ! au?ority ( ! ,secret>y ) respect to po/m>ket surveillance "u section #ehg,x4 #ehg;,j4 ,regi/ration & li/+ 7a7 ,regi/ration requirem5t 7#a7 ,9 g5]al ,ea* p]son describ$ 9 subsection 7b77#a7 %all-- 7,a7 dur+ ! p]iod beg9n+ on ,octob] #a & end+ on ,decemb] #ca ( ea* ye>1 regi/] ) ! ,secret>y ! "n ( su* p]son1 places ( bus9ess ( su* p]son1 all e/abli%m5ts engag$ 9 ! activities specifi$ "u ?is p>agraph1 ! e/abli%m5t regi/ration numb] ( ea* su* e/abli%m5t1 & a po9t ( contact = ea* su* e/abli%m5t1 includ+ an electronic po9t ( contact2 & 7,b7 submit an initial regi/ration conta9+ ! in=mation requir$ "u subp>agraph 7,a7-- 7i7 9 accordance ) ! timel9es = submission "u subsection 7c71 if ! e/abli%m5t is engag$ 9 any activity describ$ 9 subsection 7b77#a7 on ! effective date ( ?is section1 unless ! ,secret>y e/abli%es by guidance a date lat] ?an su* date = all or a category ( su* e/abli%m5ts2 or 7ii7 n lat] ?an #cj days prior to engag+ 9 any activity describ$ 9 subsection 7b77#a71 if ! e/abli%m5t is n engag$ 9 any activity describ$ 9 ?is p>agraph on ! effective date ( ?is section4 7#b7 ,regi/ration numb]s ,! ,secret>y may assign a regi/ration numb] to any p]son or an e/abli%m5t regi/ration numb] to any e/abli%m5t regi/]$ 9 accordance ) ?is section4 ,regi/ration in=mation %all be made publicly available by publication on ! website ma9ta9$ by ! ,food & ,drug ,adm9i/ration1 9 accordance ) subsection 7d74 7#c7 ,inspection ,ea* p]son or e/abli%m5t t is requir$ to be regi/]$ ) ! ,secret>y "u ?is section %all be subject to inspection pursuant to section #gjd4 7b7 ,li/+ ,in=mation = ,9 ,vitro ,cl9ical ,te/s 7#a7 ,9 g5]al ,ea* p]son :o-- 7,a7 is a develop]2 & 7,b7 introduces or proposes to beg9 ! introduction or deliv]y = introduction into int]/ate comm]ce ?r\gh an exemption "u subsection 7a77#a71 7a77#b71 7a77#c71 or 7g7 ( section #ehg;,c or section #ehg;,g or ?r\gh ! fil+ ( an application "u section #ehg;,b or section #ehg;,d1 %all submit a li/+ to ! ,secret>y conta9+ ! in=mation describ$ 9 p>agraph 7#b71 or 7#d71 z applicable1 9 accordance ) ! applicable s*$ule describ$ "u subsection 7c74 ,su* li/+ %all be prep>$ 9 su* =m & mann] z ! ,secret>y may specify 9 guidance4 ,li/+ in=mation %all be submitt$ ?r\gh ! compreh5sive te/ in=mation sy/em 9 accordance ) section #ehg,t1 z appropriate4 7#b7 ,submissions ,ea* develop] submitt+ a li/+ "u p>agraph 7#a7 %all electronically submit to ! compreh5sive te/ in=mation sy/em describ$ 9 section #ehg,t ! foll[+ in=mation1 z applicable1 = ea* 9 vitro cl9ical te/ = :i* su* p]son is a develop] 9 ! =m & mann] prescrib$ by ! ,secret>y1 tak+ into acc\nt ! lea/ burd5some requirem5ts "u section #ehg;,,aa7c73 7,a7 ,"n ( ! e/abli%m5t & its e/abli%m5t regi/ration numb]4 7,b7 ,contact in=mation = ! (ficial correspond5t = ! li/+4 7,c7 ,"n 7common "n & trade "n1 if applicable7 ( ! 9 vitro cl9ical te/ & its te/ li/+ numb] 7:5 available74 7,d7 ,! c]tificate numb] = any laboratory c]tifi$ by ! ,secret>y "u section #cec ( ! ,public ,heal? ,s]vice ,act t meets ! requirem5ts to p]=m high-complexity te/+ & t is ! develop] ( ! 9 vitro cl9ical te/1 & ! c]tificate numb] "u su* section = any laboratory t is p]=m+ ! te/1 is )9 ! same corporate organization1 & has common own]%ip by ! same p>5t corporation4 7,e7 ,:e!r ! 9 vitro cl9ical te/ is1 z applicable1 (f]$ z a te/ approv$ "u section #ehg;,b1 (f]$ "u a grant$ te*nology c]tification ord]1 or (f]$ z an exempt 9 vitro cl9ical te/ "u section #ehg;,c or #ehg;,g4 7,f7 ,indications = use in=mation "u section #ehg7aj74 7,g7 ,a brief summ>y ( ! analytical & cl9ical p]=mance ( ! 9 vitro cl9ical te/1 & z applicable1 ! lot release crit]ia4 7,h7 ,a brief description ( con=mance ) any applicable mitigat+ measures1 re/rictions1 & /&>ds4 7,i7 ,repres5tative label+ = ! 9 vitro cl9ical te/1 z appropriate4 7#c7 ,te/ li/+ numb] ,! ,secret>y may assign a te/ li/+ numb] to ea* 9 vitro cl9ical te/ t is ! subject ( a li/+ "u ?is section4 ,! process = assign+ te/ li/+ numb]s may be e/abli%$ ?r\gh guidance1 & may include ! recognition ( /&>ds1 =mats1 or conv5tions develop$ by a ?ird-p>ty organization4 7#d7 ,gr&fa!r$ te/s ,a develop] (f]+ a te/ t is a gr&fa!r$ 9 vitro cl9ical te/ "u section #ehg;,g7a7 %all submit li/+ in=mation requir$ "u subp>agraphs 7,a7 ?r\gh 7,f7 ( p>agraph 7#b71 & may submit a /atem5t ( ! p]=mance specifications = su* 9 vitro cl9ical te/s4 7#e7 ,exempt te/s ,a develop] ( an 9 vitro cl9ical te/ :o introduces or proposes to beg9 ! introduction or deliv]y = introduction into int]/ate comm]ce t is o!rwise exempt f ! requirem5t to submit li/+ in=mation pursuant to an exemption "u section #ehg;,c may submit li/+ in=mation "u ?is subsection4 7c7 ,timel9es = submission ( li/+ in=mation 7#a7 ,9 g5]al ,! timel9es = submission ( regi/ration & li/+ "u subsections 7a7 & 7b7 are z foll[s3 7,a7 ,= an 9 vitro cl9ical te/ t 0 li/$ z a device "u section #eaj7;j7 prior to ! effective date ( ?is section1 a p]son %all ma9ta9 a device li/+ "u section #eaj until su* "t z ! sy/em = submitt+ ! li/+ in=mation requir$ "u subsection 7b7 becomes available & !reaft] %all submit ! li/+ in=mation n lat] ?an ! lat] ( #a ye> aft] ! sy/em = submitt+ ! li/+ "u ?is section becomes available or ! effective date ( ?is section4 7,b7 ,= an 9 vitro cl9ical te/ t is subject to gr&fa!r+ "u section #ehg;,g7a7 a p]son %all submit ! li/+ in=mation requir$ "u subsection 7b77#d7 )9 #aj cal5d> days ( (f]+ ! te/ aft] ! effective date ( ?is section4 7,c7 ,= an 9 vitro cl9ical te/ t is n describ$ 9 subp>agraph 7,a7 or 7,b71 a p]son %all submit ! requir$ li/+ in=mation z foll[s3 7i7 ,= an 9 vitro cl9ical te/ t is n exempt f prem>ket approval "u section #ehg;,b1 a p]son %all submit ! requir$ li/+ in=mation1 prior to (f]+ ! 9 vitro cl9ical te/ & n lat] ?an #cj bus9ess days aft] ! date ( approval ( ! prem>ket approval application4 7ii7 ,= an 9 vitro cl9ical te/ t is exempt f prem>ket review "u section #ehg;,c1 ! requir$ li/+ in=mation %all be submitt$ prior to (f]+ ! 9 vitro cl9ical te/4 7#b7 ,updates 7,a7 ,updates aft] *anges ,ea* develop] requir$ to submit li/+ in=mation "u ?is section %all update su* in=mation )9 #aj bus9ess days ( any *ange t causes any previ\sly li/$ in=mation to be inaccurate or incomplete4 7,b7 ,annual updates ,ea* develop] requir$ to submit li/+ in=mation "u ?is section %all update its in=mation annually dur+ ! p]iod beg9n+ on ,octob] #a & end+ on ,decemb] #ca ( ea* ye>4 7d7 ,public availability ( li/+ in=mation 7#a7 ,9 g5]al ,li/+ in=mation submitt$ pursuant to ?is section %all be made publicly available on ! website ( ! ,food & ,drug ,adm9i/ration 9 accordance ) p>agraph 7#c74 7#b7 ,confid5tiality ,li/+ in=mation = an 9 vitro cl9ical te/ t is subject to prem>ket approval or te*nology c]tification %all rema9 confid5tial until su* date z ! 9 vitro cl9ical te/ receives ! applicable prem>ket approval or ! develop] receives a te*nology c]tification ord] & = subsequ5t te/s introduc$ "u a te*nology c]tification ord] until _! introduction4 7#c7 ,exceptions f public availability requirem5ts ,! public li/+ requirem5ts ( ?is subsection %all n apply to any regi/ration & li/+ in=mation submitt$ "u subsection 7a7 or 7b71 if ! ,secret>y det]m9es t su* in=mation-- 7,a7 is a trade secret or confid5tial comm]cial or f9ancial in=mation2 or 7,b7 if po/$1 c\ld compromise national security4 7e7 ,submission ( in=mation by accr$it$ p]sons ,if agre$ ^u by ! develop]1 ! in=mation requir$ "u ?is section may be submitt$ by a p]son accr$it$ "u section #ehg,q4 #ehg,k4 ,te/ design & quality requirem5ts 7a7 ,applicability 7#a7 ,9 g5]al ,ea* develop] %all e/abli% & ma9ta9 quality requirem5ts 9 accordance ) ! applicable requirem5ts set =? 9 subsection 7b74 7#b7 ,c]tifi$ laboratory requirem5ts ,a develop] %all e/abli% & ma9ta9 quality requirem5t "u subsection 7b77#b7 or 7b77#c71 z applicable1 if su* develop] is a cl9ical laboratory c]tifi$ by ! ,secret>y "u section #cec ( ! ,public ,heal? ,s]vice ,act t-- 7,a7 is c]tifi$ to p]=m high-complexity te/+2 7,b7 develops an 9 vitro cl9ical te/ t is = use only-- 7i7 )9 ! laboratory c]tifi$ by ! ,secret>y "u su* section #cec 9 :i* su* te/ 0 develop$2 or 7ii7 )9 ano!r laboratory c]tifi$ by ! ,secret>y "u su* section #cec if su* laboratory is-- 7,i7 )9 ! same corporate organization & has common own]%ip by ! same p>5t corporation z ! laboratory 9 :i* ! te/ 0 develop$2 or 7,,ii7 )9 a public heal? laboratory network coord9at$ or manag$ by ! ,c5t]s = ,disease ,control & ,prev5tion1 if ! te/ is develop$ by a public heal? laboratory or ! ,c5t]s = ,disease ,control & ,prev5tion2 & 7,c7 does n manufacture1 produce1 or di/ribute 9 vitro cl9ical te/s o!r ?an laboratory te/ protocols4 7#c7 ,regulations ,! ,secret>y %all promulgate quality sy/em regulations implem5t+ ?is section4 ,9 promulgat+ su* regulations "u ?is section1 ! ,secret>y %all consid] :e!r1 & to :at ext5t1 int]national h>monization is appropriate4 7#d7 ,quality sy/ems = hybrid develop]s ( bo? laboratory te/ protocols & o!r 9 vitro cl9ical te/s ,an entity t develops bo? laboratory te/ protocols & o!r 9 vitro cl9ical te/s %all comply ) subsection 7b77#a7 = activities relat$ to ! developm5t ( any 9 vitro cl9ical te/ t is n a laboratory te/ protocol & ) subsection 7b77#b7 or 7b77#c71 z applicable1 = activities relat$ to ! developm5t ( any laboratory te/ protocol4 7b7 ,quality requirem5ts 7#a7 ,9 g5]al ,! quality requirem5ts applicable "u ?is section %all-- 7,a7 avoid duplication ( regulations & guidance "u section #cec ( ! ,public ,heal? ,s]vice ,act1 su* t laboratories w\ld n be subject to conflict+ regulatory obligations ) respect to ! same activity2 7,b7 n apply to laboratory op]ations2 & 7,c7 include1 z applicable1 subject to subp>agraphs 7,a7 & 7,b7 & p>agraphs 7#b7 & 7#c7-- 7i7 managem5t responsibilities2 7ii7 quality audits2 7iii7 p]sonnel2 7iv7 design controls2 7v7 docum5t controls2 7vi7 pur*as+ controls2 7vii7 id5tification & traceability2 7viii7 production & process controls2 7ix7 acceptance activities2 7x7 noncon=m+ 9 vitro cl9ical te/s2 7xi7 corrective & prev5tive action2 7xii7 label+ & packag+ controls2 7xiii7 h&l+1 /orage1 di/ribution1 & in/allation2 7xiv7 compla9ts & records2 7xv7 s]vic+2 & 7xvi7 /ati/ical te*niques4 7#b7 ,exception = laboratory te/ protocols ,develop]s t are develop+ te/ protocols = use z describ$ 9 subsection 7a77#b77;,b77i7 are exempt f ! requirem5ts "u p>agraph 7#a77;,c7 except = ! requirem5ts describ$ 9 clauses 7iv71 7ix71 7xi71 & 7xiv7 ( su* p>agraph4 7#c7 ,quality requirem5ts = c]ta9 laboratories di/ribut+ laboratory te/ protocols )9 organizations or public heal? networks ,quality requirem5ts applicable to ! develop] :o is di/ribut+ a laboratory te/ protocol z describ$ 9 subsection 7a77#b77;,b77ii7 %all consi/ ( ! foll[+3 7,a7 ,clauses 7iv71 7ix71 7xi71 7xiv71 7xii7 ( p>agraph 7#a77;,b74 7,b7 ,! requirem5t to ma9ta9 records ( ! laboratories to :i* ! laboratory te/ protocol is di/ribut$4 7c7 ,regulations ,9 implem5t+ quality requirem5ts = te/ develop]s t p>ticipate 9 int]national audit programs "u ?is section1 ! ,secret>y %all-- 7#a7 = purposes ( facilitat+ int]national h>monization1 consid] :e!r ! develop] p>ticipates 9 an int]national audit program 9 :i* ! ,unit$ ,/ates p>ticipates & recognizes compliance )1 or con=mance to1 su* /&>ds recogniz$ by ! ,secret>y2 & 7#b7 ensure a lea/ burd5some approa* describ$ 9 section #ehg;,,aa7c7 by lev]ag+1 to ! ext5t applicable1 ! quality assurance requirem5ts applicable to develop]s c]tifi$ by ! ,secret>y "u section #cec ( ! ,public ,heal? ,s]vice ,act4 #ehg,l4 ,label+ requirem5ts 7a7 ,9 g5]al ,an 9 vitro cl9ical te/ %all be> or be accompani$ by label+1 z applicable1 t meets ! requirem5ts set =? 9 subsections 7b7 & 7c71 unless su* te/ is exempt "u subsection 7d7 or 7e74 7b7 ,labels 7#a7 ,9 g5]al ,! label ( an 9 vitro cl9ical te/1 %all meet ! requirem5ts set =? 9 p>agraph 7#b7 if !re is an imm$iate conta9] to :i* ! label is appli$4 7#b7 ,regulations ,! label ( an 9 vitro cl9ical te/ %all /ate ! "n & place ( bus9ess ( its develop] & meet ! requirem5ts set =? 9 regulations promulgat$ 9 accordance ) ?is section4 7c7 ,label+ 7#a7 ,9 g5]al ,label+ ( an 9 vitro cl9ical te/1 includ+ label+ 9 ! =m ( a package ins]t1 website1 /&alone laboratory ref]5ce docum5t1 or o!r simil> docum5t %all include-- 7,a7 adequate directions = use & %all meet ! requirem5ts set =? 9 regulations promulgat$ "u ?is section1 except z provid$ 9 subsection 7d7 or 7e72 & 7,b7 ! in=mation describ$ 9 p>agraph 7#b71 z applicable4 7#b7 ,cont5t ,label+ ( an 9 vitro cl9ical te/ %all include-- 7,a7 ! te/ li/+ numb] t 0 provid$ to ! develop] at ! "t ( li/+2 7,b7 in=mation to facilitate report+ an adv]se ev5t2 7,c7 in=mation reg>d+ access+ ! p]=mance summ>y data display$ 9 ! li/+ database = ! te/2 7,d7 ! indications = use ( ! 9 vitro cl9ical te/2 & 7,e7 any w>n+s1 contra9dications1 or limitations4 7#c7 ,public availability ( in=mation ,! ,secret>y %all make all ( ! in=mation describ$ 9 p>agraph 7#b7 ) respect to ea* 9 vitro cl9ical te/ available to ! public1 z applicable1 9 accordance ) section #ehg,t1 except to ! ext5t t ! ,secret>y det]m9es t su* in=mation-- 7,a7 is trade secret or confid5tial comm]cial or f9ancial in=mation2 or 7,b7 if po/$1 c\ld compromise national security4 7#d7 ,additional requirem5ts ,label+ = an 9 vitro cl9ical te/ us$ = immunohematology te/+ %all meet ! applicable requirem5ts set =? 9 "p #ffj ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations71 relat$ to ! label+ ( blood gr\p+ reag5ts1 reag5t r$ blood cells1 & anti-human globul94 7d7 ,exemptions & alt]native requirem5ts 7#a7 ,9 g5]al 7,a7 ,9 g5]al ,) respect to an 9 vitro cl9ical te/ t meets ! crit]ia ( subp>agraph 7,b71 ! /ate 9 "o place regulations "u section #hji4aj7;b7 ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations7 may be satisfi$ by ! laboratory po/+ su* in=mation on its website or 9 multiple docum5ts1 if su* docum5ts are ma9ta9$ & accessible 9 "o place4 7,b7 ,applicable te/s ,an 9 vitro cl9ical te/ meets ! crit]ia ( ?is subp>agraph if su* te/ is-- 7i7 develop$ by a laboratory c]tifi$ by ! ,secret>y "u section #cec ( ! ,public ,heal? ,s]vice ,act t meets ! requirem5ts to p]=m te/s ( high-complexity2 & 7ii7 p]=m$ 9-- 7,i7 ! same laboratory 9 :i* su* te/ 0 develop$2 or 7,,ii7 by ano!r laboratory c]tifi$ by ! ,secret>y "u section #cec ( ! ,public ,heal? ,s]vice ,act t-- 7aa7 meets ! requirem5ts to p]=m te/s ( high complexity2 & 7bb7 is "u common own]%ip & control z ! laboratory t develop$ ! te/4 7#b7 ,te/ in/rum5t label+ ,unless ! in/rum5t is ! entire te/ sy/em1 ! label+ = an in/rum5t is n requir$ to be> ! in=mation indicat$ 9 p>agraphs 7#c71 7#d71 7#e71 7#g71 7#h71 7#i71 7#aj71 7#aa71 7#ab71 & 7#ac7 ( section #hji4aj7;b7 ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations74 7#c7 ,reag5t label+ ,= purposes ( compliance ) subsection 7c77#a71 ! label+ = a reag5t int5d$ = use z a replacem5t 9 an 9 vitro cl9ical te/ may be limit$ to t in=mation necess>y to id5tify ! reag5t adequately & to describe its prop] use 9 ! te/4 7#d7 ,inve/igational use ,a %ipm5t or o!r deliv]y ( an 9 vitro cl9ical te/ = inve/igational use pursuant to section #ehg,s %all be exempt f ! label+ requirem5ts ( subsections 7b7 & 7c77#a7 & f any /&>d promulgat$ ?r\gh regulations1 except z requir$ "u section #cec ( ! ,public ,heal? ,s]vice ,act or section #ehg,r ( ?is ,act4 7#e7 ,g5]al purpose laboratory reag5ts ,! label+ ( g5]al purpose laboratory reag5ts 7su* z hydro*loric acid7 ^: uses are g5]ally kn[n by p]sons tra9$ 9 _! use ne$ n be> ! directions = use requir$ by subsection 7c77#a77;,a74 7#f7 ,ov]-!-c\nt] te/ specim5 receptacle label+ ,! label+ = ov]-!-c\nt] te/ specim5 receptacles = drugs ( abuse te/+ %all be> ! "n & place ( bus9ess ( ! develop] includ$ 9 ! regi/ration "u section #ehg;,j & any in=mation specifi$ 9 applicable regulations promulgat$ "u ?is section1 9 language appropriate = ! int5d$ us]s4 7e7 ,te/s 9 ! /rategic national /ockpile 7#a7 ,9 g5]al ,! ,secret>y may grant an exception or alt]native to any provision li/$ 9 ?is section1 unless explicitly requir$ by a /atutory provision outside ?is sub*apt]1 = specifi$ lots1 bat*es1 or o!r units ( an 9 vitro cl9ical te/1 if ! ,secret>y det]m9es t compliance ) su* label+ requirem5t c\ld adv]sely affect ! availability ( su* products t are1 or w be1 includ$ 9 ! ,/rategic ,national ,/ockpile "u section #cai;,f-#b ( ! ,public ,heal? ,s]vice ,act4 7#b7 ,regulations ,! ,secret>y may issue regulations am5d+ section #hji4aa ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulation7 to apply 9 full or 9 "p to 9 vitro cl9ical te/s & 9 vitro cl9ical te/ develop]s4 7f7 ,regulations ,! ,secret>y %all issue regulations relat$ to /&>diz$1 g5]al cont5t & =mat = 9 vitro cl9ical te/ label+ pursuant to ?is subsection4 #ehg,m4 ,adv]se ev5t report+ 7a7 ,9 g5]al ,ea* 9 vitro cl9ical te/ develop] %all e/abli% & ma9ta9 a sy/em = e/abli%+ & ma9ta9+ records ( adv]se ev5ts & report+ adv]se ev5ts 9 accordance ) ?is section4 7b7 ,submission ( individual reports ,a develop] %all submit an individual adv]se ev5t report n lat] ?an #e cal5d> days aft] ! develop] receives or becomes aw>e ( an adv]se ev5t t reasonably sugge/s t an 9 vitro cl9ical te/ may-- 7#a7 h caus$ or contribut$ to a pati5t or us] dea?2 or 7#b7 pres5t an imm95t ?reat to public heal?4 7c7 ,submission ( qu>t]ly reports ,z applicable1 a develop] %all submit qu>t]ly reports t include any 9 vitro cl9ical te/ errors & s]i\s injuries t occurr$ dur+ ! applicable qu>t]4 ,su* qu>t]ly reports %all be submitt$ n lat] ?an ! end ( ! qu>t] foll[+ ! qu>t] 9 :i* ! develop] receives or becomes aw>e ( su* adv]se ev5ts4 7d7 ,def9itions ,= ! purposes ( ?is section-- 7#a7 ! t]m 9 vitro cl9ical te/ error means a failure ( an 9 vitro cl9ical te/ to meet its p]=mance specifications1 or to o!rwise p]=m z int5d$ by ! develop]1 includ+ an inaccurate result result+ f su* failure2 & 7#b7 ! t]m s]i\s injury means-- 7,a7 a significant delay 9 a diagnosis t results 9 ! abs5ce1 delay1 or discont9uation ( critical m$ical treatm5t or t irrev]sibly or s]i\sly & negatively alt]s ! c\rse ( a disease or condition2 or 7,b7 an injury t-- 7i7 is life ?reat5+2 7ii7 results 9 p]man5t impairm5t ( a body function or p]man5t damage to a body /ructure2 or 7iii7 necessitates m$ical or surgical int]v5tion to preclude p]man5t impairm5t ( a body function or p]man5t damage to a body /ructure4 7e7 ,regulations ,! ,secret>y %all promulgate regulations to implem5t ?is section4 #ehg,n4 ,corrections & removals 7a7 ,regulations ,! ,secret>y %all promulgate regulations1 or am5d exi/+ regulations1 z appropriate1 to implem5t ?is section4 7b7 ,reports ( corrections & removals 7#a7 ,9 g5]al ,ea* 9 vitro cl9ical te/ develop] %all report to ! ,secret>y any correction or removal ( an 9 vitro cl9ical te/ und]tak5 by su* develop] if ! correction or removal 0 und]tak5-- 7,a7 to r$uce ! risk to heal? pos$ by ! 9 vitro cl9ical te/2 or 7,b7 to rem$y a violation ( ?is ,act caus$ by ! 9 vitro cl9ical te/ :i* may pres5t a risk to heal?4 7#b7 ,exception = 9 vitro cl9ical te/s (f]$ "u a te*nology c]tification ord] ,= any eligible te/ (f]$ "u a te*nology c]tification ord] "u section #ehg;,d1 a correction & removal report = any correction or removal ( an 9 vitro cl9ical te/ %\ld demon/rate t ! issue or issues caus+ ! correction or removal d n adv]sely impact ! ability ( o!r 9 vitro cl9ical te/s (f]$ "u ! same te*nology c]tification ord] to meet ! applicable /&>d4 7c7 ,tim+ ,a develop] %all submit any report requir$ "u ?is subsection to ! ,secret>y )9 #ae bus9ess days ( initiat+ su* correction or removal4 7d7 ,recordkeep+ ,a develop] ( an 9 vitro cl9ical te/ t und]takes a correction or removal ( an 9 vitro cl9ical te/ :i* is n requir$ to be report$ "u ?is subsection %all keep a record ( su* correction or removal4 7e7 ,recall communications ,^u ! report+ ( a correction or removal by ! develop]-- 7#a7 ! ,secret>y %all classify su* correction or removal "u ?is section )9 #de cal5d> days2 & 7#b7 n lat] ?an #gj cal5d> days aft] ! develop] or o!r responsible p>ty notifies ! ,secret>y t x has complet$ a recall action1 ! ,secret>y %all provide ! develop] or o!r responsible p>ty ) a writt5 /atem5t clos+ ! recall action or /at+ ! reasons ! ,secret>y _c close ! recall at t "t4 #ehg,o4 ,re/rict$ 9 vitro cl9ical te/s 7a7 ,applicability 7#a7 ,9 g5]al ,= ! types ( 9 vitro cl9ical te/s describ$ 9 p>agraph 7#c71 ! ,secret>y may require1 9 issu+ an approval ( an 9 vitro cl9ical te/ "u section #ehg;,b1 grant+ a te*nology c]tification ord] "u section #ehg;,d1 or 9 issu+ a det]m9ation "u section #ehg;,f7a71 or by issu+ a regulation1 t su* te/1 or category ( te/s1 be re/rict$ to sale1 di/ribution1 or use ^u su* conditions z ! ,secret>y may prescribe "u p>agraph 7#b74 7#b7 ,conditions ,! ,secret>y may prescribe conditions "u ?is section1 bas$ on available evid5ce1 ) respect to an 9 vitro cl9ical te/ describ$ 9 p>agraph 7#c71 t are det]m9$ to be ne$$ due to ! pot5tial = h>mful effect ( su* te/ 7includ+ any result+ abs5ce1 significant delay1 or discont9uation ( appropriate m$ical treatm5t71 & are necess>y to ensure t ! te/ meets ! applicable /&>d4 7#c7 ,9 vitro cl9ical te/s subject to re/rictions ,! re/rictions or conditions au?oriz$ "u ?is section may be appli$ by ! ,secret>y to any high-risk or mod]ate-risk 9 vitro cl9ical te/1 prescription home-use 9 vitro cl9ical te/1 direct-to-consum] 9 vitro cl9ical te/1 or ov]-!-c\nt] 9 vitro cl9ical te/4 7b7 ,label+ & adv]tis+ ( a re/rict$ 9 vitro cl9ical te/ ,! label+ & adv]tis+ ( an 9 vitro cl9ical te/ to :i* re/rictions apply "u subsection 7a7 %all be> su* appropriate /atem5ts ( ! re/rictions z ! ,secret>y may prescribe 9 an approval "u section #ehg;,b1 an ord] "u section #ehg;,d1 a det]m9ation "u section #ehg;,f7a71 or 9 regulation1 z applicable4 7c7 ,device re/rictions ,an 9 vitro cl9ical te/ t 0 (f]$ z a re/rict$ device prior to ! date ( enactm5t ( ?is sub*apt]-- 7#a7 %all cont9ue to comply ) ! applicable re/rictions "u section #eae or section #ebj7;e7 until ?is sub*apt] takes effect2 & 7#b7 except = 9 vitro cl9ical te/s requir$ to meet ! requirem5ts ( section #hji4cj ( title #ba1 ,code ( ,f$]al ,regulations prior to ! effective date ( ?is sub*apt] specifi$ 9 section #e7;a77#a77;,a7 ( ! ,,valid ,act ( #bjbc1 su* re/rictions describ$ 9 p>agraph 7#a7 %all be deem$ to be re/rictions "u ?is sub*apt] z ( su* effective date4 #ehg,p4 ,appeals 7a7 ,significant decision 7#a7 ,9 g5]al ,! ,secret>y %all-- 7,a7 ma9ta9 a sub/antive summ>y ( ! sci5tific & regulatory rationale = any significant decision ( ! ,food & ,drug ,adm9i/ration pursuant to section #ehg;,f1 reg>d+-- 7i7 ! submission ( an application =1 or a review (1 an 9 vitro cl9ical te/ "u section #ehg;,b or section #ehg;,d2 7ii7 an exemption "u section #ehg;,c2 or 7iii7 any requirem5ts = mitigation measures to an 9 vitro cl9ical te/ or category ( 9 vitro cl9ical te/s2 & 7,b7 include 9 su* summ>ies docum5tation ( significant controv]sies or diff]5ces ( op9ion & ! resolution ( su* controv]sies or diff]5ces ( op9ion4 7#b7 ,provision ( docum5tation ,^u reque/1 ! ,secret>y %all furni% a sub/antive summ>y describ$ 9 p>agraph 7#a7 to ! p]son :o has made1 or is seek+ to make1 a submission describ$ 9 su* p>agraph4 7#c7 ,application ( lea/ burd5some requirem5ts ,! sub/antive summ>y requir$ "u ?is subsection %all include a brief /atem5t reg>d+ h[ ! lea/ burd5some requirem5ts 7 consid]$ & appli$ consi/5t ) section #ehg;,,aa7c71 z applicable4 7b7 ,review ( significant decisions 7#a7 ,reque/ = sup]visory review ( significant decision ,a develop] may reque/ a sup]visory review ( ! significant decision describ$ 9 subsection 7a77#a74 ,su* review may be conduct$ at ! next sup]visory level or high] above ! ag5cy (ficial :o made ! significant decision4 7#b7 ,submission ( reque/ ,a develop] reque/+ a sup]visory review "u p>agraph 7#a7 %all submit su* reque/ to ! ,secret>y n lat] ?an #cj days aft] ! decision = :i* ! review is reque/$ & %all indicate 9 ! reque/ :e!r su* develop] seeks an 9-p]son meet+ or a teleconf]5ce review4 7#c7 ,timeframe ,! ,secret>y %all s*$ule an 9-p]son or teleconf]5ce review1 if s reque/$1 n lat] ?an #cj days aft] su* reque/ is made4 ,! ,secret>y %all issue a decision to ! develop] reque/+ a review "u ?is subsection n lat] ?an #de days aft] ! reque/ is made "u p>agraph 7#a71 or1 9 ! case ( a develop] :o reque/s an 9-p]son meet+ or teleconf]5ce1 #cj days aft] su* meet+ or teleconf]5ce4 7c7 ,advisory panels ,! process e/abli%$ "u subsection 7a7 %all p]mit ! appellant to reque/ review by an advisory committee e/abli%$ "u section #ehg;,g :5 !re is a dispute involv+ sub/antial sci5tific fact4 ,if an advisory panel meet+ is held1 ! ,secret>y %all make a det]m9ation "u ?is subsection n lat] ?an #de days aft] ! reque/$ advisory committee meet+ has conclud$4 7d7 ,lea/ burd5some review ,any develop] :o has submitt$ an application "u section #ehg;,b or #ehg;,d may reque/ a sup]visory review ( a reque/ = additional in=mation dur+ an evaluation ( su* submission )9 #fj cal5d> days ( receipt ( ! additional in=mation reque/ f ! ,secret>y4 7e7 ,availability ( all rem$ies ,! proc$ures set =? 9 ?is section %all be 9 addition to1 & n 9 lieu (1 o!r rem$ies available to ! develop]4 #ehg,q4 ,accr$it$ p]sons 7a7 ,9 g5]al 7#a7 ,au?orization ,beg9n+ on ! date ( enactm5t ( ! ,,valid ,act ( #bjbc1 ! ,secret>y %all accr$it p]sons = any ( ! foll[+ purposes3 7,a7 ,review+ applications = prem>ket approval "u section #ehg;,b & mak+ f9d+s ) respect to su* applications4 7,b7 ,review+ applications = te*nology c]tification "u section #ehg;,d & mak+ recomm5dations to ! ,secret>y ) respect to su* applications4 7,c7 ,conduct+ inspections z specifi$ 9 subsection 7c7 ( 9 vitro cl9ical te/ develop]s & o!r p]sons requir$ to regi/] pursuant to section #ehg;,j4 7#b7 ,p]sons submitt+ applications ,a p]son submitt+ an application = prem>ket approval "u section #ehg;,b or an application = te*nology c]tification "u section #ehg;,d may submit su* application to ! ,secret>y or to a p]son accr$it$ pursuant to subp>agraph 7,a7 or 7,b7 ( p>agraph 7#a74 7b7 ,accr$it$ p]sons application reviews1 f9d+s1 & recomm5dations 7#a7 ,requirem5ts = prem>ket application 7,a7 ,review1 f9d+1 & recomm5dation requirem5ts ,an accr$it$ p]son receiv+ an application = prem>ket approval "u section #ehg;,b %all ei!r-- 7i7 provide to ! ,secret>y1 toge!r ) ! application = prem>ket approval submitt$ by ! applicant1 a recomm5dation bas$ on a f9d+ t ! crit]ia = approval ( ! application "u section #ehg;,b7e77#b77;,a7 are met & issue a copy ( su* f9d+ to ! applicant1 :i* f9d+ %all pla9ly /ate-- 7,i7 ! basis = ! accr$it$ p]son's f9d+ t ! crit]ia "u section #ehg;,b7e77#b77;,a7 are met2 & 7,,ii7 any propos$ re/rictions1 mitigat+ measures1 or conditions ( approval "u section #ehg;,b7e77#b77;,b71 z applicable2 or 7ii7 provide a notification to ! applicant t ! accr$it$ p]son _c f9d t ! crit]ia = approval ( ! application "u section #ehg;,b7e77#b77;,a7 are met & ! reasons = su* decision4 7,b7 ,reque/+ miss+ or cl>ify+ in=mation ,aft] receipt ( an application f an accr$it$ p]son "u ?is section1 ! ,secret>y may reque/ miss+ or cl>ify+ in=mation f ! applicant conc]n+ ! application1 :i* ! accr$it$ p]son %all promptly provide4 7,c7 ,secret>y action on recomm5dation t approval crit]ia are met ,if ! accr$it$ p]son transmits a recomm5dation to ! ,secret>y "u subp>agraph 7,a77i71 !n prior to ! date t is #de cal5d> days aft] ! transmittal date1 ! ,secret>y %all consid] su* recomm5dation & make a det]m9ation to-- 7i7 approve ! application = prem>ket approval "u section #ehg;,b7e77#b7 ) appropriate re/rictions1 mitigat+ measures1 or conditions ( approval1 z applicable2 or 7ii7 d5y approval ( ! application by issu+ a writt5 notice t reflects appropriate managem5t input & concurr5ce to ! accr$it$ p]son & ! applicant detail+ ! sci5tific basis = ! ,secret>y's det]m9ation t ! crit]ia = issuance ( an approval "u section #ehg;,b7e77#b77;,a7 h n be5 met4 7,d7 ,effect ( inaction on recomm5dation ,if ! ,secret>y fails to take an action "u subp>agraph 7,c7 ! ,secret>y %all-- 7i7 )9 #de cal5d> days aft] ! transmittal date1 provide writt5 fe$back to ! applicant t-- 7,i7 includes all out/&+ issues ) ! application prev5t+ ! ,secret>y f tak+ an action "u subp>agraph 7,b72 7,,ii7 reflects appropriate managem5t input & concurr5ce2 & 7,,iii7 includes action items = ! ,secret>y1 ! applicant1 or bo?1 z appropriate1 ) an e/imat$ date ( completion = ! ,secret>y & ! applicant to complete _! respective tasks1 z applicable2 & 7ii7 promptly s*$ule a meet+ or teleconf]5ce to discuss ! fe$back provid$ "u clause 7i71 unless ! ,secret>y & applicant agree t ! out/&+ issues are adequately pres5t$ ?r\gh writt5 correspond5ce & a meet+ or teleconf]5ce is n necess>y4 7#b7 ,requirem5ts = te*nology c]tification 7,a7 ,review & recomm5dation requirem5ts ,an accr$it$ p]son receiv+ an application = te*nology c]tification "u section #ehg;,d %all ei!r-- 7i7 provide to ! ,secret>y1 toge!r ) ! application = te*nology c]tification submitt$ by ! applicant1 a recomm5dation t ! crit]ia = issuance ( a te*nology c]tification ord] "u section #ehg;,d7d77#c7 are met & issue a copy ( su* recomm5dation to ! applicant1 :i* recomm5dation %all pla9ly /ate ! basis = ! accr$it$ p]son's recomm5dation t ! crit]ia "u section #ehg;,d7d77#c7 are met2 or 7ii7 provide a notification to ! applicant t ! accr$it$ p]son _c recomm5d t ! crit]ia = issuance ( a te*nology c]tification ord] "u section #ehg;,d7d77#c7 are met & ! reasons = su* decision4 7,b7 ,reque/+ miss+ or cl>ify+ in=mation ,aft] receipt ( an application "u ?is section1 ! accr$it$ p]son may reque/ miss+ or cl>ify+ in=mation f ! applicant conc]n+ ! application1 :i* ! applicant %all promptly provide4 7,c7 ,secret>y action on recomm5dation = issuance ( a te*nology c]tification ord] ,if ! accr$it$ p]son transmits a recomm5dation to ! ,secret>y "u clause 7i7 ( subp>agraph 7,a71 !n prior to ! date t is #fj cal5d> days aft] ! transmittal date ! ,secret>y %all-- 7i7 issue ! te*nology c]tification ord] "u section #ehg;,d7d77#c71 consi/5t ) su* recomm5dation f ! accr$it$ p]son2 or 7ii7 d5y approval ( ! application by issu+ a writt5 notice to ! accr$it$ p]son & ! applicant detail+ ! sci5tific basis = a det]m9ation by ! ,secret>y t ! crit]ia = issuance ( a te*nology c]tification ord] "u section #ehg;,d7d77#c7 h n be5 met4 7c7 ,requirem5ts = inspections 7#a7 ,9 g5]al ,:5 conduct+ inspection1 p]sons accr$it$ "u subsection 7a77#a77;,c7 %all record 9 writ+ _! specific obs]vations & %all pres5t _! obs]vations to ! designat$ repres5tative ( ! inspect$ e/abli%m5t4 7#b7 ,inspection report requirem5ts ,ea* p]son accr$it$ "u subsection 7a77#a77;,c7 %all prep>e & submit to ! ,secret>y an inspection report 9 a =m & mann] designat$ by ! ,secret>y = conduct+ inspections4 ,any /atem5t or repres5tation made by an employee or ag5t ( an e/abli%m5t to a p]son accr$it$ to conduct inspections "u subsection 7a77#a77;,c7 %all be subject to section #ajja ( title #ah1 ,unit$ ,/ates ,code4 7#c7 ,sav+s clause ,no?+ 9 ?is section affects ! au?ority ( ! ,secret>y to inspect any 9 vitro cl9ical te/ develop] or o!r p]son regi/]$ "u section #ehg;,j or recognize inspections conduct$ by audit+ organizations z describ$ "u section #gjd7;g77#ae74 7#d7 ,inspection limitations ,! ,secret>y %all ensure t inspections c>ri$ out "u ?is section are n duplicative ( inspections c>ri$ out "u section #cec ( ! ,public ,heal? ,s]vice ,act4 ,inspections "u ?is section %all be limit$ to ! data & in=mation necess>y-- 7,a7 = r\t9e surveillance activities ( facilities associat$ ) an approv$ application "u section #ehg;,b or issuance ( a te*nology c]tification ord] "u section #ehg;,d2 or 7,b7 to meet ! requirem5ts = prem>ket approval "u section #ehg;,b or issuance ( a te*nology c]tification ord] "u section #ehg;,d1 z applicable4 7d7 ,accr$itation 7#a7 ,accr$itation program ,! ,secret>y may provide = accr$itation "u ?is section ?r\gh programs adm9i/]$ by ! ,food & ,drug ,adm9i/ration1 by o!r non-,f$]al gov]nm5t ag5cies1 or by qualifi$ nongov]nm5tal organizations4 ,a p]son may be accr$it$ = ! review ( applications submitt$ "u sections #ehg;,b z describ$ 9 subsection 7a77#a77;,a71 = ! review ( applications submitt$ "u section #ehg;,d z describ$ 9 subsection 7a77#a77;,b71 & to conduct inspection activities "u subsection 7a77#a77;,c71 or = a subset ( su* reviews or activities4 7#b7 ,eligible p]sons 7,a7 ,m9imum qualifications ,an accr$it$ p]son1 at a m9imum1 %all-- 7i7 n be an employee ( ! ,f$]al ,gov]nm5t2 7ii7 n engage 9 ! activities ( a develop]1 z def9$ 9 section #ehg7g72 7iii7 n be a p]son requir$ to regi/] "u section #ehg;,j1 unless su* p]son has e/abli%$ suffici5t processes & protocols to sep>ate activities to develop 9 vitro cl9ical te/s & ! activities = :i* su* p]son w\ld be accr$it$ "u subsection 7a7 & discloses applicable in=mation "u ?is section2 7iv7 n be own$ or controll$ by1 & %all h no organizational1 mat]ial1 or f9ancial affiliation )1 an 9 vitro cl9ical te/ develop] or o!r p]son requir$ to regi/] "u section #ehg;,j2 7v7 be a legally con/itut$ entity p]mitt$ to conduct ! activities = :i* x seeks accr$itation2 7vi7 ensure t ! op]ations ( su* p]son are 9 accordance ) g5]ally accept$ pr(essional & e?ical bus9ess practices2 & 7vii7 include 9 its reque/ = accr$itation a commitm5t to1 at ! "t ( accr$itation & at any "t x is p]=m+ activities pursuant to ?is section-- 7,i7 c]tify t ! in=mation report$ to ! ,secret>y accurately reflects ! data or protocol review$1 & ! docum5t$ inspection f9d+s1 z applicable2 7,,ii7 limit "w to t = :i* compet5ce & capacity are available2 7,,iii7 treat in=mation receiv$ or le>n$1 records1 reports1 & recomm5dations z propriet>y in=mation ( ! p]son submitt+ su* in=mation2 & 7,,iv7 9 conduct+ ! activities = :i* ! p]son is accr$it$ 9 respect to a p>ticul> 9 vitro cl9ical te/1 protect aga9/ ! use ( any employee or consultant :o has a f9ancial conflict ( int]e/ reg>d+ t 9 vitro cl9ical te/4 7,b7 ,waiv] ,! ,secret>y may waive any requirem5ts 9 clause 7i71 7ii71 7iii71 or 7iv7 ( subp>agraph 7,a7 ^u mak+ a det]m9ation t su* p]son has implem5t$ o!r appropriate controls suffici5t to ensure a compet5t & imp>tial review4 7#c7 ,accr$itation process 7,a7 ,accr$itation process guidance & regulations ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,,valid ,act ( #bjbc1 ! ,secret>y %all issue draft guidance specify+ ! process = submitt+ a reque/ = accr$itation & reaccr$itation "u ?is section1 includ+ ! =m & cont5t ( in=mation to be submitt$1 includ+ ! crit]ia t ! ,secret>y w consid] to accr$it or d5y accr$itation &1 n lat] ?an #a ye> aft] ! close ( ! comm5t p]iod = ! draft guidance1 issue f9al guidance4 7,b7 ,response to reque/ ,! ,secret>y %all respond to a reque/ = accr$itation or reaccr$itation )9 #fj cal5d> days ( ! receipt ( ! reque/4 ,! ,secret>y's response may be to accr$it or reaccr$it ! p]son1 to d5y accr$itation1 or to reque/ additional in=mation 9 support ( ! reque/4 ,if ! ,secret>y reque/s additional in=mation1 ! ,secret>y %all respond )9 #fj cal5d> days ( receipt ( su* additional in=mation to accr$it or d5y ! accr$itation4 7,c7 ,type ( accr$itation ,! accr$itation or reaccr$itation ( a p]son %all specify ! p>ticul> activity or activities "u subsection 7a7 = :i* su* p]son is accr$it$1 & %all include any limitation to c]ta9 eligible 9 vitro cl9ical te/s4 7,d7 ,public li/ ,! ,secret>y %all publi% on ! website ( ! ,food & ,drug ,adm9i/ration a li/ ( p]sons :o are accr$it$ "u ?is section4 ,su* li/ %all be updat$ on at lea/ a mon?ly basis4 ,! li/ %all specify ! p>ticul> activity or activities "u ?is section = :i* ! p]son is accr$it$4 7,e7 ,audit ,! ,secret>y may audit ! p]=mance ( p]sons accr$it$ "u ?is section = purposes ( ensur+ t su* p]sons cont9ue to meet ! publi%$ crit]ia = accr$itation1 & may modify ! scope or p>ticul> activities = :i* a p]son is accr$it$ if ! ,secret>y det]m9es t su* p]son fails to meet "o or m crit]ia = accr$itation4 7,f7 ,susp5sion or )drawal ,! ,secret>y may susp5d or )draw accr$itation ( any p]son accr$it$ "u ?is section1 aft] provid+ notice & an opportunity = an in=mal he>+1 :5 su* p]son is sub/antially n 9 compliance ) ! requirem5ts ( ?is section or ! publi%$ crit]ia = accr$itation1 or poses a ?reat to public heal?1 or fails to act 9 a mann] t is consi/5t ) ! purposes ( ?is section4 7,g7 ,reaccr$itation ,accr$it$ p]sons may be initially accr$it$ = up to #c ye>s4 ,aft] expiration ( su* initial p]iod1 p]sons may be reaccr$it$ = unlimit$ additional #e-ye> p]iods1 z det]m9$ by ! ,secret>y4 7e7 ,comp5sation ( accr$it$ p]sons ,comp5sation ( an accr$it$ p]son %all be det]m9$ by agreem5t betwe5 ! accr$it$ p]son & ! p]son :o engages ! s]vices ( ! accr$it$ p]son1 & %all be paid by ! p]son :o engages su* s]vices4 7f7 ,int]national h>monization ,not)/&+ any o!r provision ( ?is section1 to facilitate int]national h>monization ! ,secret>y may recognize p]sons accr$it$ or recogniz$ by gov]nm5ts1 :o h also ent]$ into in=mation %>+ agreem5ts1 includ+ confid5tiality commitm5ts1 ) ! ,commission] ( ,food & ,drugs4 7g7 ,in=mation %>+ agreem5ts ,an accr$it$ p]son may ent] into an agreem5t ) a te/ develop] to provide in=mation to ! compreh5sive te/ in=mation sy/em "u section #ehg,t1 includ+ any requirem5ts "u section #ehg;,j4 7h7 ,reports ,n lat] ?an #b ye>s aft] ! effective date ( ! ,,valid ,act ( #bjbc1 & annually !reaft] = ! next #d ye>s1 ! ,secret>y %all po/ on ! website ( ! ,food & ,drug ,adm9i/ration1 a report describ+ ! ,secret>y's p]=mance 9 implem5t+ ?is section1 includ+ ! ,secret>y's progress 9 m9imiz+ duplicative reviews ( applications = :i* an accr$it$ p]son f9ds ! crit]ia = approval are met4 ,su* reports %all include1 = ea* p]iod-- 7#a7 ) reg>d to prem>ket approval applications-- 7,a7 ! total numb] ( f9d+s transmitt$ to ! ,secret>y "u subsection 7b77#a77;,a77i72 7,b7 ! total numb] ( det]m9ations made by ! ,secret>y "u subsection 7b77#a77;,b77i7 )9 #cj cal5d> days ( ! transmittal date to approve an application2 7,c7 ! total numb] ( det]m9ations made by ! ,secret>y "u subsection 7b77#a77;,b77ii7 )9 #cj cal5d> days ( ! transmittal date to d5y approval ( an application2 & 7,d7 ! total numb] ( applications t 7 approv$ & ! total numb] ( applications t 7 d5i$ approval1 aft] ! ,secret>y fail$ to make a det]m9ation )9 #cj cal5d> days ( ! transmittal date "u subsection 7b77#a77;,b72 & 7#b7 ) reg>d to applications = te*nology c]tification-- 7,a7 ! total numb] ( recomm5dations transmitt$ to ! ,secret>y "u subsection 7b77#b77;,a77i72 7,b7 ! total numb] ( det]m9ations made by ! ,secret>y "u subsection 7b77#b77;,b77i7 to issue a te*nology c]tification ord]1 includ+ det]m9ations made )9 #cj days ( ! transmittal date2 7,c7 ! total numb] ( det]m9ations made by ! ,secret>y "u subsection 7b77#b77;,b77ii7 to d5y ! application = te*nology c]tification1 includ+ det]m9ations made )9 #cj cal5d> days ( ! transmittal date2 & 7,d7 ! total numb] ( te*nology c]tification ord]s issu$1 & ! total numb] ( applications = te*nology c]tification t 7 d5i$1 includ+ applications d5i$ aft] ! ,secret>y fail$ to make a det]m9ation )9 #cj cal5d> days ( ! transmittal date "u subsection 7b77#b77;,b74 #ehg,r4 ,recogniz$ /&>ds 7a7 ,9 g5]al ,! ,secret>y may recognize all or "p ( appropriate /&>ds e/abli%$ by nationally or int]nationally recogniz$ /&>ds developm5t organizations = :i* a p]son may submit a decl>ation ( con=mity 9 ord] to meet a requirem5t "u ?is sub*apt] to :i* t /&>d is applicable4 ,/&>ds = 9 vitro diagno/ic devices previ\sly recogniz$ "u section #ead7;c7 %all be consid]$ recogniz$ /&>ds "u ?is section4 ,recogniz$ & propos$ /&>ds %all be accessible to ! public at no *>ge4 ,! application ( any su* cons5sus /&>d %all only apply prospectively4 ,! ,secret>y %all issue regulations e/abli%+ ! crit]ia & process1 = su* recognition & adoption4 7b7 ,am5dm5t process ,! proc$ures e/abli%$ 9 ?is section or 9 regulation or guidance issu$ "u ?is section %all apply to am5dm5t ( an exi/+ /&>d4 #ehg,s4 ,inve/igational use 7a7 ,9 g5]al ,subject to ! conditions prescrib$ 9 subsections 7c71 7d71 7e71 7f71 & 7g71 an 9 vitro cl9ical te/ = inve/igational use %all be exempt f ! requirem5ts ( ?is sub*apt]1 o!r ?an sections #ehg;,a1 #ehg,p1 #ehg,t1 & #ehg,v4 ,! ,secret>y may am5d p>ts #ej1 #ed1 & #ef ( title #ba ( ! ,code ( ,f$]al ,regulations to apply to 9 vitro cl9ical te/s to p]mit ! inve/igational use ( su* te/s by exp]ts qualifi$ by sci5tific tra9+ & exp]i5ce4 7b7 ,regulations 7#a7 ,9 g5]al ,n lat] ?an #c ye>s aft] ! date ( enactm5t ( ! ,,valid ,act ( #bjbc1 ! ,secret>y %all promulgate regulations to implem5t ?is section4 7#b7 ,v>iation ,! requirem5ts 9 ! regulations promulgat$ "u ?is section %all take into acc\nt v>iations bas$ on-- 7,a7 ! scope & duration ( cl9ical te/+ to be conduct$ "u inve/igation t is ! subject ( su* application2 7,b7 ! numb] ( human subjects t are to be involv$ 9 su* te/+2 7,c7 ! ne$ to p]mit *anges to be made to ! 9 vitro cl9ical te/ involv$ dur+ te/+ conduct$ 9 accordance ) a plan requir$ "u subsection 7c77#f72 or 7,d7 :e!r ! cl9ical te/+ ( su* 9 vitro cl9ical te/ is = ! purpose ( develop+ data to obta9 approval to (f] su* te/4 7c7 ,application = inve/igational use ,! foll[+ %all apply ) respect to 9 vitro cl9ical te/s = inve/igational use3 7#a7 ,significant risk & o!r /udies ,9 ! case ( an 9 vitro cl9ical te/ ! inve/igational use ( :i* poses a significant risk to ! human subject or involves an exception f in=m$ cons5t = em]g5cy rese>*1 a sponsor ( an inve/igation ( su* a te/ seek+ an inve/igational use exemption %all submit to ! ,secret>y an inve/igational use application ) respect to ! 9 vitro cl9ical te/ 9 accordance ) p>agraphs 7#c7 & 7#d74 7#b7 ,non-significant risk /udies ,9 ! case ( an 9 vitro cl9ical te/1 ! inve/igational use ( :i* is n describ$ 9 p>agraph 7#a7-- 7,a7 ! sponsor ( su* inve/igation %all-- 7i7 ensure su* inve/igation is conduct$ 9 compliance ) an inve/igational plan approv$ by an in/itutional review committee & ! label+ ( ! 9 vitro cl9ical te/ involv$ cle>ly & conspicu\sly /ates1 ,= inve/igational use only1 z specifi$ 9 p>agraph 7#d77;,a77ii72 7ii7 ensure ea* inve/igator obta9s in=m$ cons5t z requir$ "u "p #ej1 #ed1 & #ef ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations71 subject to ! exceptions set =? 9 p>agraph 7#f77;,c72 7iii7 e/abli% & ma9ta9 records ) respect to all requirem5ts 9 ?is subp>agraph2 7iv7 ma9ta9 records & make reports z requir$ by ! ,secret>y pursuant to regulations issu$ "u subsection 7b72 & 7v7 ensure t inve/igators monitor inve/igations1 ma9ta9 records & make reports z requir$ by ! ,secret>y pursuant to regulations issu$ "u subsection 7b72 & 7,b7 ! sponsor may rely on any exception or exemption describ$ 9 p>agraph 7#d7 or z e/abli%$ by ! ,secret>y 9 regulations issu$ "u subsection 7b74 7#c7 ,application ,an inve/igational use application %all be submitt$ 9 su* "t & mann] & conta9 su* in=mation z ! ,secret>y may require 9 regulation1 & %all include an inve/igational plan = propos$ cl9ical te/+ & assurances t ! sponsor submitt+ ! application w-- 7,a7 e/abli% & ma9ta9 records relevant to ! inve/igation ( su* 9 vitro cl9ical te/2 & 7,b7 submit to ! ,secret>y annual reports ( data obta9$ z a result ( ! inve/igational use ( ! 9 vitro cl9ical te/ dur+ ! p]iod cov]$ by ! exemption t ! ,secret>y reasonably det]m9es w enable ! ,secret>y-- 7i7 to ensure compliance ) ! conditions = ! exemption specifi$ 9 p>agraph 7#d72 7ii7 to review ! progress ( ! inve/igation involv$2 & 7iii7 to evaluate ! ability to meet ! applicable /&>d4 7#d7 ,conditions = exemption ,an application = an inve/igational use exemption ) respect to a significant risk /udy %all be grant$ if ea* ( ! foll[+ conditions is met3 7,a7 ,! risks to ! subjects ( ! 9 vitro cl9ical te/ are outweigh$ by ! anticipat$ b5efits ( ! te/ to ! subjects & ! importance ( ! k to be ga9$1 & adequate assurance ( in=m$ cons5t is provid$ 9 accordance ) p>agraphs 7#f77;,b7 & 7#f77;,c74 7,b7 ,! propos$ label+ = ! 9 vitro cl9ical te/ involv$ cle>ly & conspicu\sly /ates ,= inve/igational use only4 7,c7 ,su* o!r requirem5ts ! ,secret>y det]m9es-- 7i7 are necess>y = ! protection ( ! public heal? & safety2 & 7ii7 d n unduly delay inve/igation4 7#e7 ,coord9ation ) inve/igational new drug applications ,any requirem5t = ! submission ( a report to ! ,secret>y pursuant to an application = an inve/igational new drug exemption involv+ an 9 vitro cl9ical te/ %all sup]s$e ! report+ requirem5t "u p>agraph 7#c77;,b71 b only to ! ext5t ! requirem5t ) respect to ! application = exemption ) respect to ! drug is duplicative ( ! report+ requirem5t "u su* p>agraph4 7#f7 ,inve/igational plan1 proc$ures1 & conditions ,) respect to an inve/igational plan submitt$ "u p>agraph 7#c71 ! sponsor submitt+ su* plan %all-- 7,a7 promptly notify ! ,secret>y ( ! approval or ! susp5sion or t]m9ation ( ! approval ( su* plan by an in/itutional review committee2 7,b7 9 ! case ( an 9 vitro cl9ical te/ made available to inve/igators = cl9ical te/+1 obta9 agreem5ts f ea* inve/igator t any te/+ ( ! 9 vitro cl9ical te/ involv+ human subjects w be "u su* inve/igator's sup]vision & 9 accordance ) p>agraph 7,c7 & submit su* agreem5ts to ! ,secret>y t ensure-- 7i7 all inve/igators w comply ) ?is section1 regulations promulgat$ or revis$ "u ?is section1 & applicable human subjects regulations2 & 7ii7 ! inve/igator w ensure t-- 7,i7 in=m$ cons5t is obta9$ z requir$ "u "p #ej ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations71 am5d$ to apply to 9 vitro cl9ical te/s2 & 7,,ii7 ! requirem5ts = in/itutional review bo>d "u "p #ef ( title #ba ( ! ,code ( ,f$]al ,regulations 7or successor regulations71 am5d$ to apply to 9 vitro cl9ical te/s1 are met2 & 7,c7 ensure t in=m$ cons5t w be obta9$ f ea* human subject 7or ! repres5tative ( su* subject7 ( propos$ cl9ical te/+ involv+ su* 9 vitro cl9ical te/1 except :]e1 subject to su* o!r conditions z ! ,secret>y may prescribe-- 7i7 ! propos$ cl9ical te/+ poses no m ?an m9imal risk to ! human subject & includes appropriate safegu>ds to protect ! rights1 safety1 & welf>e ( ! human subject2 or 7ii7 ! inve/igator conduct+ or sup]vis+ ! cl9ical te/+ det]m9es 9 writ+ t !re exi/s a life-?reat5+ situation involv+ ! human subject ( su* te/+ :i* necessitates ! use ( su* 9 vitro cl9ical te/ & x is n feasible to obta9 in=m$ cons5t f ! subject & !re is n suffici5t "t to obta9 su* cons5t f a repres5tative ( su* subject4 7#g7 ,concurr$ by lic5s$ physician ,! det]m9ation requir$ by p>agraph 7#f77;,c77ii7 %all be concurr$ 9 writ+ by a lic5s$ physician :o is n involv$ 9 ! te/+ ( ! human subject ) respect to :i* su* det]m9ation is made unless imm$iate use ( ! 9 vitro cl9ical te/ is requir$ to save ! life ( ! human subject ( su* te/+ & !re is n suffici5t "t to obta9 su* concurr5ce4 7#h7 ,significant risk ,= purposes ( ?is subsection1 ! t]m significant risk means1 ) respect to an 9 vitro cl9ical te/1 t ! use ( su* 9 vitro cl9ical te/-- 7,a7 is ( sub/antial importance 9 p]=m+ an activity or activities describ$ 9 section #bja7ss77#a7 =1 a s]i\s or life-?reat5+ disease or condition )\t confirmation ( ! diagnosis by a m$ically e/abli%$ diagno/ic product or proc$ure2 7,b7 requires an invasive sampl+ proc$ure t pres5ts a significant risk to ! human subject1 provid$ t r\t9e v5ipuncture %all n be consid]$ an invasive sampl+ proc$ure2 or 7,c7 o!rwise pres5ts a pot5tial = s]i\s risk to ! heal? ( a human subject4 7d7 ,review ( applications 7#a7 ,9 g5]al ,! ,secret>y may issue an ord] approv+ an inve/igation z propos$1 approv+ x ) conditions or modifications1 or disapprov+ x4 7#b7 ,failure to act ,unless ! ,secret>y1 n lat] ?an #cj cal5d> days aft] ! date ( ! submission ( an application = an inve/igational use exemption t meets ! requirem5ts ( subsection 7c71 issues an ord] "u p>agraph 7#a7 & notifies ! sponsor submitt+ ! application1 ! application %all be treat$ z approv$ z ( su* date )\t fur!r action by ! ,secret>y4 7#c7 ,d5ial ,! ,secret>y may d5y an inve/igational use application submitt$ "u ?is subsection if ! ,secret>y det]m9es t ! inve/igation ) respect to :i* ! application is submitt$ does n con=m to ! requirem5ts ( subsection 7c74 ,a notification ( su* d5ial submitt$ to ! sponsor ) respect to su* a reque/ %all conta9 ! ord] ( disapproval & a complete /atem5t ( ! reasons = ! ,secret>y's d5ial ( ! application4 7e7 ,)drawal ( exemption 7#a7 ,9 g5]al ,! ,secret>y may1 by adm9i/rative ord]1 )draw an exemption approv$ "u ?is section ) respect to an 9 vitro cl9ical te/1 includ+ an exemption treat$ z approv$ bas$ on ! ,secret>y's failure to act pursuant to subsection 7d77#b71 if ! ,secret>y det]m9es t an inve/igation conduct$ "u su* an exemption does n meet ! applicable conditions "u subsection 7c77#c7 = su* exemption4 7#b7 ,opportunity to be he>d 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 an ord] )draw+ an inve/igational use exemption grant$ "u ?is section may be issu$ only aft] ! ,secret>y provides ! sponsor ( ! 9 vitro cl9ical te/ ) an opportunity = an in=mal he>+4 7,b7 ,exception ,an ord] ref]r$ to 9 subp>agraph 7,a7 ) respect to an inve/igational use exemption grant$ "u ?is section may be issu$ on a prelim9>y basis be=e ! provision ( an opportunity = an in=mal he>+ if ! ,secret>y det]m9es t ! cont9uation ( te/+ "u ! exemption w result 9 an unreasonable risk to ! public heal?4 ,! ,secret>y w provide an opportunity = an in=mal he>+ promptly foll[+ any prelim9>y action "u ?is subp>agraph4 7f7 ,*anges 7#a7 ,9 g5]al ,! regulations promulgat$ "u subsection 7b7 %all provide1 ) respect to an 9 vitro cl9ical te/ = :i* an exemption "u ?is subsection is 9 effect1 proc$ures & conditions "u :i* *anges are all[$ )\t ! additional approval ( an application = an exemption or submission ( a supplem5t to su* an application4 ,su* regulations %all provide t su* a *ange may be made if-- 7,a7 ! sponsor det]m9es1 on ! basis ( cr$ible in=mation 7z def9$ 9 regulations7 t ! *ange meets ! conditions specifi$ 9 p>agraph 7#b72 & 7,b7 ! sponsor submits to ! ,secret>y1 n lat] ?an #e cal5d> days aft] mak+ ! *ange1 a notice ( ! *ange4 7#b7 ,conditions ,! conditions specifi$ 9 ?is p>agraph are t-- 7,a7 9 ! case ( developm5tal *anges to an 9 vitro cl9ical te/1 includ+ manufactur+ *anges1 ! *anges-- 7i7 d n con/itute a significant *ange 9 design or 9 basic pr9ciples ( op]ation2 7ii7 d n affect ! rights1 safety1 or welf>e ( ! human subjects involv$ 9 ! inve/igation2 & 7iii7 are made 9 response to in=mation ga!r$ dur+ ! c\rse ( an inve/igation2 & 7,b7 9 ! case ( *anges to cl9ical protocols applicable to ! te/1 ! *anges d n affect-- 7i7 ! validity ( data or in=mation result+ f ! completion ( an approv$ cl9ical protocol1 or ! relation%ip ( likely pati5t risk to b5efit reli$ ^u to approve a product2 7ii7 ! sci5tific s\ndness ( a plan submitt$ "u subsection 7c77#c72 or 7iii7 ! rights1 safety1 or welf>e ( ! human subjects involv$ 9 ! inve/igation4 7g7 ,cl9ical hold 7#a7 ,9 g5]al ,at any "t1 ! ,secret>y may impose a cl9ical hold ) respect to an inve/igation ( an 9 vitro cl9ical te/ if ! ,secret>y makes a writt5 det]m9ation describ$ 9 p>agraph 7#b74 ,! ,secret>y %all1 9 impos+ su* cl9ical hold1 specify ! basis = ! cl9ical hold1 includ+ ! specific in=mation available to ! ,secret>y :i* s]v$ z ! basis = su* cl9ical hold1 & confirm su* det]m9ation 9 writ+4 ,! applicant may imm$iately appeal any su* det]m9ation pursuant to section #ehg,p4 7#b7 ,det]m9ation 7,a7 ,9 g5]al ,= purposes ( p>agraph 7#a71 a det]m9ation describ$ 9 ?is subp>agraph ) respect to a cl9ical hold is a det]m9ation t1 bas$ on cr$ible evid5ce1 ! 9 vitro cl9ical te/ involv$ repres5ts an unreasonable risk to ! safety ( ! p]sons :o are ! subjects ( ! cl9ical inve/igation1 tak+ into acc\nt ! qualifications ( ! cl9ical inve/igators1 in=mation ab\t ! 9 vitro cl9ical te/1 ! design ( ! cl9ical inve/igation1 ! condition = :i* ! 9 vitro cl9ical te/ is to be inve/igat$1 & ! heal? /atus ( ! subjects involv$4 7,b7 ,removal ( cl9ical hold ,any writt5 reque/ to ! ,secret>y f ! sponsor ( an inve/igation t a cl9ical hold be remov$ %all receive a decision1 9 writ+ & specify+ ! reasons !re=1 )9 #cj days aft] receipt ( su* reque/4 ,any su* reque/ %all include suffici5t in=mation to support ! removal ( su* cl9ical hold4 #ehg,t4 ,compreh5sive te/ in=mation sy/em 7a7 ,e/abli%m5t ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,,valid ,act ( #bjbc1 ! ,secret>y %all make available a compreh5sive te/ in=mation sy/em = 9 vitro cl9ical te/s t is design$ to-- 7#a7 provide a transp>5t int]face on ! website ( ! ,food & ,drug ,adm9i/ration = /akehold]s1 to ! ext5t p]mitt$ by applicable law1 :i* may include access to !-- 7,a7 regulatory pa?way designation in=mation = ea* 9 vitro cl9ical te/ or te/s ) ! same indications = use2 7,b7 regi/ration & li/+ in=mation provid$ by develop]s "u section #ehg;,j1 includ+ ! use ( a l9k = labels2 7,c7 adv]se ev5t reports submitt$ "u section #ehg,m1 z appropriate2 7,d7 reports ( corrections & removals submitt$ "u section #ehg,n2 & 7,e7 o!r in=mation p]ta9+ to an 9 vitro cl9ical te/ or te/s ) ! same indications = use1 z ! ,secret>y det]m9es appropriate2 & 7#b7 provide a secure portal = electronic submission1 includ+ applications & o!r 9 vitro cl9ical te/ submissions1 regi/ration & li/+ in=mation1 & adv]se ev5t reports1 :i* provides protections f unau?oriz$ disclosure ( in=mation1 includ+ (-- 7,a7 trade secret or confid5tial comm]cial or f9ancial in=mation2 & 7,b7 in=mation t c\ld compromise national security4 7b7 ,submission function ,! compreh5sive te/ in=mation sy/em %all s]ve z ! electronic submission s]vice = te/ develop]s submitt+ in=mation = applications "u sections #ehg;,b & #ehg;,d4 #ehg,u4 ,preemption 7a7 ,9 g5]al ,except z provid$ 9 subsection 7b71 no ,/ate1 ,tribal1 or local gov]nm5t 7or political subdivision !re(7 may e/abli% or cont9ue 9 effect any requirem5t-- 7#a7 t is diff]5t f1 or 9 addition to1 any requirem5t applicable to an 9 vitro cl9ical te/ "u ?is ,act2 or 7#b7 ) respect to ! analytical validity1 cl9ical validity1 or safety = individuals :o come into contact ) su* an 9 vitro cl9ical te/4 7b7 ,exceptions ,subsection 7a7 %all n be con/ru$ to affect ! au?ority ( a ,/ate1 ,tribal1 or local gov]nm5t to d any ( ! foll[+3 7#a7 ,to lic5se laboratory p]sonnel1 heal? c>e practition]s1 or heal? c>e facilities or to regulate any aspect ( a heal? c>e practition]-pati5t relation%ip4 7#b7 ,to en=ce laws ( g5]al applicability1 su* z zon+ laws1 environm5tal laws1 labor laws1 & g5]al bus9ess laws4 7#c7 ,to au?orize laboratories to develop & p]=m an 9 vitro cl9ical te/1 pursuant to a law enact$ by a ,/ate prior to ,janu>y #a1 #bjbb1 z long z su* law does n impose requirem5ts t are diff]5t f any requirem5t applicable to an 9 vitro cl9ical te/ "u ?is ,act4 ,if a ,/ate has enact$ su* a law1 ! ,secret>y %all exempt su* te/ = laboratories 9 t ,/ate f compliance ) ?is sub*apt]4 7c7 ,cl>ification ,no?+ 9 ?is section %all be con/ru$ to-- 7#a7 modify any action = damages or ! liability ( any p]son "u ! law ( any ,/ate2 or 7#b7 %ift liability to heal? c>e practition]s or o!r us]s4 #ehg,v4 ,adult]ation ,an 9 vitro cl9ical te/ %all be deem$ to be adult]at$3 7#a7 ,if x consi/s 9 :ole or 9 "p ( any fil?y1 putrid1 or decompos$ sub/ance4 7#b7 ,if x has be5 develop$1 prep>$1 pack$1 or held "u insanit>y conditions :]eby x may h be5 contam9at$ ) fil?1 or :]eby x may h be5 r5d]$ injuri\s to heal?4 7#c7 ,if its conta9] or package is compos$1 9 :ole or 9 "p1 ( any poison\s or delet]i\s sub/ance :i* may r5d] ! cont5ts injuri\s to heal?4 7#d7 ,if x be>s or conta9s1 = purposes ( color+ only1 a color additive :i* is unsafe )9 ! mean+ ( section #gba7;a74 7#e7 ,if its analytical or cl9ical validity1 z applicable1 or ) respect to a specim5 receptacle1 its safety1 falls bel[ t :i* x purports or is repres5t$ to possess4 7#f7 ,if x is requir$ to be1 decl>$ to be1 purports to be1 or is repres5t$ z be+1 9 con=mity ) any p]=mance /&>d e/abli%$ or recogniz$ "u section #ehg,r & is n 9 con=mity ) su* /&>d4 7#g7 ,if x is requir$ to be 9 compliance ) mitigat+ measures e/abli%$ "u section #ehg;,e & is n 9 con=mity ) su* mitigat+ measures4 7#h7 ,if x fails to h 9 effect an approv$ prem>ket application "u section #ehg;,b1 unless su* 9 vitro cl9ical te/ is 9 compliance ) ! requirem5ts =-- 7,a7 (f]+ )\t an approv$ prem>ket application "u section #ehg;,d7b77#a72 7,b7 an exemption f prem>ket approval "u section #ehg;,c or #ehg;,g2 or 7,c7 inve/igational use pursuant to section #ehg,s4 7#i7 ,if x is n 9 con=mity ) any condition e/abli%$ "u section #ehg;,b or #ehg;,d4 7#aj7 ,if x purports to be an 9 vitro cl9ical te/ subject to an exemption "u section #ehg;,c & x fails to meet or ma9ta9 any crit]ia1 condition1 or requirem5t ( su* exemption4 7#aa7 ,if x has be5 grant$ an exemption "u section #ehg,s = inve/igational use1 & ! p]son grant$ su* exemption or any inve/igator :o uses su* 9 vitro cl9ical te/ "u su* exemption fails to comply ) a requirem5t prescrib$ by or "u su* section4 7#ab7 ,if x fails to meet ! quality requirem5ts prescrib$ 9 or e/abli%$ "u section #ehg,k 7z applicable71 or ! me?ods us$ 91 or facilities or controls us$ =1 its developm5t1 packag+1 /orage1 or in/allation are n 9 con=mity ) applicable requirem5ts e/abli%$ "u su* section4 7#ac7 ,if x has be5 develop$1 process$1 packag$1 or held 9 any e/abli%m5t1 factory1 or w>eh\se & ! own]1 op]ator or ag5t ( su* e/abli%m5t1 factory1 or w>eh\se delays1 d5ies1 or limits an inspection1 or refuses to p]mit entry or inspection4 7#ad7 ,if x is n 9 compliance ) any re/riction requir$ "u section #ehg,o4 #ehg,w4 ,misbr&+ ,an 9 vitro cl9ical te/ %all be deem$ to be misbr&$3 7#a7 ,if its label+ is false or mislead+ 9 any p>ticul>4 7#b7 ,if 9 a package =m unless x be>s a label conta9+-- 7,a7 ! "n & place ( bus9ess ( ! te/ develop]1 packag]1 or di/ributor2 & 7,b7 an accurate /atem5t ( ! quantity ( cont5ts 9 t]ms ( weight1 measure1 or num]ical c\nt1 unless an exemption is grant$ by ! ,secret>y by ! issuance ( guidance1 su* z ) respect to small packages4 7#c7 ,if any ^w1 /atem5t1 or o!r in=mation requir$ by or "u au?ority ( ?is ,act to appe> on ! label or label+1 includ+ a te/ report1 is n prom95tly plac$ !reon ) su* conspicu\sness 7z comp>$ ) o!r words1 /atem5ts1 designs1 or devices1 9 ! label+7 & 9 su* t]ms z to r5d] x likely to be read & und]/ood by ! ord9>y individual "u cu/om>y conditions ( pur*ase & use4 7#d7 ,unless its label+ be>s adequate directions = use & su* adequate w>n+s z are necess>y = ! protection ( us]s ( ! 9 vitro cl9ical te/ & recipi5ts ( ! results ( su* 9 vitro cl9ical te/1 includ+ pati5ts1 consum]s1 donors1 & relat$ heal? c>e pr(essionals4 ,requir$ label+ = 9 vitro cl9ical te/s int5d$ = use 9 heal? c>e facilities1 blood e/abli%m5ts1 or by a heal? c>e pr(essional may be made available solely by electronic means1 provid$ t ! label+ complies ) all applicable requirem5ts ( law1 & t ! te/ develop]1 or di/ributor af=ds su* us]s ! opportunity to reque/ ! label+ 9 pap] =m1 & aft] su* reque/1 promptly provides ! reque/$ in=mation )\t additional co/4 7#e7 ,if !re is a reasonable probability t x c\ld cause s]i\s or adv]se heal? consequ5ces or dea?1 includ+ ?r\gh abs5ce1 delay1 or discont9uation 9 diagnosis or treatm5t1 :5 us$ 9 ! mann] prescrib$1 recomm5d$1 or sugge/$ 9 ! label+ !re(4 7#f7 ,if x 0 develop$1 /]iliz$1 packag$1 repackag$1 relabel$1 in/all$1 or import$ 9 an e/abli%m5t n duly regi/]$ "u section #ehg;,j or x 0 n includ$ 9 a li/+ "u section #ehg;,j1 9 accordance ) timely report+ requirem5ts "u ?is sub*apt]4 7#g7 ,9 ! case ( any 9 vitro cl9ical te/ subject to re/rictions "u section #ehg,o1 7#a7 if its adv]tis+ is false or mislead+ 9 any p>ticul>1 7#b7 if x is (f]$ = cl9ical use1 sold1 di/ribut$1 or us$ 9 violation ( su* re/rictions1 or 7#c7 unless ! te/ develop] or di/ributor includes 9 all adv]tisem5ts & o!r descriptive pr9t$ matt] t su* p]son issues or causes to be issu$1 a brief /atem5t ( ! indications = use ( ! 9 vitro cl9ical te/ & relevant w>n+s1 precautions1 side effects1 & contra9dications4 ,?is p>agraph %all n be applicable to any pr9t$ matt] t ! ,secret>y det]m9es to be label+ z def9$ 9 section #bja7m74 7#h7 ,if x is subject to a mitigat+ measure e/abli%$ "u section #ehg;,e & does n be> su* label+ z may be prescrib$ 9 su* mitigat+ measure4 7#i7 ,if x is subject to a /&>d e/abli%$ "u section #ehg,r & x does n be> su* label+ z may be prescrib$ 9 su* /&>d4 7#aj7 ,unless x be>s su* label+ z may be requir$ by or e/abli%$ "u an applicable label+ requirem5t "u ?is ,act4 7#aa7 ,if !re 0 a failure to comply ) any requirem5t prescrib$ 9 or "u section #ehg;,d1 #ehg;,j1 #ehg,k1 #ehg,l1 #ehg,m1 #ehg,n1 #ehg,x1 #ehg,y1 #ehg,z1 or to provide any report1 mat]ial1 or o!r in=mation requir$ ) respect to 9 vitro cl9ical te/s "u ?is sub*apt]4 #ehg,x4 ,po/m>ket surveillance 7a7 ,9 g5]al 7#a7 ,9 g5]al ,9 addition to o!r applicable requirem5ts "u ?is ,act1 ! ,secret>y may issue an ord] requir+ a develop] ( a high-risk or mod]ate-risk 9 vitro cl9ical te/ to conduct po/m>ket surveillance ( su* 9 vitro cl9ical te/1 if ! failure ( ! 9 vitro cl9ical te/ is reasonably likely to result 9 s]i\s adv]se heal? consequ5ces or dea? f use ( su* 9 vitro cl9ical te/4 7#b7 ,consid]ation ,9 det]m9+ :e!r to require a develop] to conduct po/m>ket surveillance ( an 9 vitro cl9ical te/1 ! ,secret>y %all take into consid]ation ! b5efits & risks = ! pati5t & ! lea/ burd5some requirem5ts "u section #ehg;,,aa7c74 7b7 ,surveillance approval 7#a7 ,9 g5]al ,ea* develop] requir$ to conduct surveillance ( an 9 vitro cl9ical te/ %all submit1 )9 #cj days ( receiv+ an ord] f ! ,secret>y1 a plan = ! requir$ surveillance4 ,! ,secret>y1 )9 #fj days ( ! receipt ( su* plan1 %all det]m9e if ! p]son designat$ to conduct ! surveillance has ! appropriate qualifications & exp]i5ce to und]take su* surveillance & if ! plan w result 9 useful data t c reveal un=ese5 adv]se ev5ts or o!r in=mation necess>y to protect ! heal? ( pati5ts or ! public4 7#b7 ,timel9e ,! develop] %all comm5ce surveillance "u ?is section n lat] ?an #ae mon?s aft] ! day on :i* ! ,secret>y ord]s su* po/m>ket surveillance1 unless ! ,secret>y det]m9es m "t is ne$$ to comm5ce surveillance4 7#c7 ,prospective surveillance ,! ,secret>y may ord] a prospective surveillance p]iod ( up to #c ye>s4 ,any det]m9ation by ! ,secret>y t a long] p]iod is necess>y %all be made by mutual agreem5t betwe5 ! ,secret>y & ! develop] or1 if no agreem5t c be rea*$1 ^u ! completion ( a dispute resolution process pursuant to section #efb4 #ehg,y4 ,electronic =mat = submissions 7a7 ,9 g5]al ,all submissions to ! ,food & ,drug ,adm9i/ration ) respect to an 9 vitro cl9ical te/1 unless o!rwise agre$ to by ! ,secret>y1 %all-- 7#a7 be made electronically2 & 7#b7 ) respect to ! in=mation requir$ "u sections #ehg;,b & #ehg;,d1 utilize ! sy/em describ$ 9 section #ehg,t4 7b7 ,electronic =mat ,beg9n+ on su* date z ! ,secret>y specifies 9 f9al guidance issu$ "u subsection 7c71 submissions = 9 vitro cl9ical te/s1 includ+ recomm5dations submitt$ by accr$it$ & recogniz$ p]sons "u section #ehg,q1 & any appeals ( action tak5 by ! ,secret>y ) respect to su* submissions1 %all be submitt$ 9 su* electronic =mat z specifi$ by ! ,secret>y 9 su* guidance4 7c7 ,guidance ,! ,secret>y %all issue guidance implem5t+ ?is section4 ,su* guidance may-- 7#a7 provide /&>ds = ! electronic submission requir$ "u subsection 7a7 or ! submission 9 electronic =mat requir$ "u subsection 7b72 7#b7 set =? crit]ia = waiv]s (1 or exemptions f1 ! requirem5ts ( subsection 7a7 or 7b72 & 7#c7 provide any o!r in=mation = ! effici5t implem5tation & en=cem5t ( ?is section4 #ehg,z4 ,po/m>ket rem$ies 7a7 ,safety ,notice 7#a7 ,9 g5]al ,if ! ,secret>y det]m9es t an 9 vitro cl9ical te/ pres5ts an unreasonable risk ( sub/antial h>m to ! public heal?1 & notification "u ?is subsection is necess>y to elim9ate ! unreasonable risk ( su* h>m & no m practicable means is available "u ! provisions ( ?is ,act 7o!r ?an ?is section7 to elim9ate ! risk1 ! ,secret>y may issue su* ord] z may be necess>y to ensure t adequate safety notice is provid$ 9 an appropriate =m1 by ! p]sons & means be/ suit$ "u ! circum/ances1 to all heal? c>e pr(essionals :o prescribe1 ord]1 or use ! 9 vitro cl9ical te/ & to any o!r p]son 7includ+ develop]s1 import]s1 di/ributors1 retail]s1 & us]s7 :o %\ld prop]ly receive su* notice4 7#b7 ,notice to individuals ,an ord] "u ?is subsection %all require t ! individuals subject to ! risk ) respect to :i* ! ord] is to be issu$ be includ$ 9 ! p]sons to be notifi$ ( ! risk unless ! ,secret>y det]m9es t notice to su* individuals w\ld pres5t a great] dang] to ! heal? ( su* individuals ?an no su* notice4 ,if ! ,secret>y makes su* a det]m9ation ) respect to su* individuals1 ! ord] %all require ! heal? c>e pr(essionals :o prescrib$1 ord]$1 or us$ ! 9 vitro cl9ical te/ provide notification to ! individuals = :om ! heal? pr(essionals prescrib$1 ord]$1 or us$ su* te/1 ( ! risk pres5t$ by su* 9 vitro cl9ical te/ & ( any action :i* may be tak5 by or on behalf ( su* individuals to elim9ate or r$uce su* risk4 ,be=e issu+ an ord] "u ?is subsection1 ! ,secret>y %all consult ) ! p]sons requir$ to give notice "u ! ord]4 7b7 ,repair1 ,replacem5t1 or ,refund 7#a7 ,det]m9ation aft] an in=mal he>+ 7,a7 ,9 g5]al ,if1 aft] af=d+ opportunity = an in=mal he>+1 ! ,secret>y det]m9es t-- 7i7 an 9 vitro cl9ical te/ pres5ts an unreasonable risk ( sub/antial h>m to ! public heal?2 7ii7 !re are reasonable gr\nds to believe t ! 9 vitro cl9ical te/ 0 n prop]ly develop$ or manufactur$ consid]+ ! /ate ( ! art z x exi/$ at ! "t ( its developm5t2 7iii7 !re are reasonable gr\nds to believe t ! unreasonable risk 0 n caus$ by failure ( a p]son o!r ?an a develop]1 import]1 di/ributor1 or retail] ( ! 9 vitro cl9ical te/ to ex]cise due c>e 9 ! in/allation1 ma9t5ance1 repair1 or use ( ! 9 vitro cl9ical te/2 & 7iv7 ! notice au?oriz$ by subsection 7a7 w\ld n by itself be suffici5t to elim9ate ! unreasonable risk & action describ$ 9 p>agraph 7#b7 ( ?is subsection is necess>y to elim9ate su* risk1 ! ,secret>y may ord] ! develop]1 import]1 or any di/ributor ( su* 9 vitro cl9ical te/1 or any comb9ation ( su* p]sons1 to submit to him )9 a reasonable "t a plan = tak+ "o or m ( ! actions describ$ 9 p>agraph 7#b74 ,an ord] issu$ "u ! prec$+ s5t5ce :i* is direct$ to m ?an "o p]son %all specify :i* p]son may decide :i* action %all be tak5 "u su* plan & ! p]son specifi$ %all be ! p]son :o ! ,secret>y det]m9es be>s ! pr9cipal1 ultimate f9ancial responsibility = action tak5 "u ! plan unless ! ,secret>y _c det]m9e :o be>s su* responsibility or ! ,secret>y det]m9es t ! protection ( ! public heal? requires t su* decision be made by a p]son 7includ+ a heal? pr(essional or us] ( ! 9 vitro cl9ical te/7 o!r ?an ! p]son ! ,secret>y det]m9es be>s su* responsibility4 7,b7 ,secret>y approval ( plan ,! ,secret>y %all approve a plan submitt$ pursuant to an ord] issu$ "u subp>agraph 7,a7 unless ! ,secret>y det]m9es 7aft] af=d+ opportunity = an in=mal he>+7 t ! action or actions to be tak5 "u ! plan or ! mann] 9 :i* su* action or actions are to be tak5 "u ! plan w n assure t ! unreasonable risk ) respect to :i* su* ord] 0 issu$ w be elim9at$4 ,if ! ,secret>y disapproves a plan1 ! ,secret>y %all ord] a revis$ plan to be submitt$ )9 a reasonable "t4 ,if ! ,secret>y det]m9es 7aft] af=d+ opportunity = an in=mal he>+7 t ! revis$ plan is unsatisfactory or if no revis$ plan or no initial plan has be5 submitt$ to ! ,secret>y )9 ! prescrib$ "t1 ! ,secret>y %all-- 7i7 prescribe a plan to be c>ri$ out by ! p]son or p]sons to :om ! ord] issu$ "u subp>agraph 7,a7 0 direct$2 or 7ii7 aft] af=d+ an opportunity = an in=mal he>+1 by ord] prescribe a plan to be c>ri$ out by a p]son :o is a develop]1 import]1 di/ributor1 or retail] ( ! 9 vitro cl9ical te/ ) respect to :i* ! ord] 0 issu$ b to :om ! ord] "u subp>agraph 7,a7 0 n direct$4 7#b7 ,actions on a plan ,! actions t may be tak5 "u a plan submitt$ "u an ord] issu$ "u p>agraph 7#a77;,a7 are z foll[s3 7,a7 ,to repair ! 9 vitro cl9ical te/ s t x does n pres5t ! unreasonable risk ( sub/antial h>m ) respect to :i* ! ord] "u p>agraph 7#a77;,a7 0 issu$4 7,b7 ,to replace ! 9 vitro cl9ical te/ ) a l or equival5t te/ :i* is 9 con=mity ) all applicable requirem5ts ( ?is ,act4 7,c7 ,to refund ! pur*ase price ( ! 9 vitro cl9ical te/ 7less a reasonable all[ance = use if su* 9 vitro cl9ical te/ has be5 9 ! possession ( ! us] = "o ye> or m at ! "t ( notice ord]$ "u subsection 7a71 or at ! "t ! us] receives actual notice ( ! unreasonable risk ) respect to :i* ! ord] 0 issu$ "u p>agraph 7#a77;,a71 :i*ev] occurs fir/74 7#c7 ,no *>ge ,no *>ge %all be made to any p]son 7o!r ?an a develop]1 import]1 di/ributor1 or retail]7 = us+ a rem$y describ$ 9 p>agraph 7#b7 & provid$ "u an ord] issu$ "u p>agraph 7#a71 & ! p]son subject to ! ord] %all reimburse ea* p]son 7o!r ?an a develop]1 manufactur]1 import]1 di/ributor1 or retail]7 :o is entitl$ to su* a rem$y = any reasonable & =eseeable exp5ses actually incurr$ by su* p]son 9 us+ su* rem$y4 7c7 ,reimbursem5t ,an ord] issu$ "u subsection 7b77#a77;,a7 ) respect to an 9 vitro cl9ical te/ may require any p]son :o is a develop]1 import]1 di/ributor1 or retail] ( ! 9 vitro cl9ical te/ to reimburse any o!r p]son :o is a develop]1 import]1 di/ributor1 or retail] ( su* 9 vitro cl9ical te/ = su* o!r p]son's exp5ses actually incurr$ 9 connection ) c>ry+ out ! ord] if ! ,secret>y det]m9es su* reimbursem5t is requir$ = ! protection ( ! public heal?4 ,any su* requirem5t %all n affect any rights or obligations "u any contract to :i* ! p]son receiv+ reimbursem5t or ! p]son mak+ su* reimbursem5t is a p>ty4 7d7 ,recall ,au?ority 7#a7 ,9 g5]al ,if ! ,secret>y f9ds t !re is a reasonable probability t an 9 vitro cl9ical te/ approv$ "u section #ehg;,b or (f]$ "u a te*nology c]tification ord] "u section #ehg;,d w\ld cause s]i\s1 adv]se heal? consequ5ces or dea?1 includ+ by ! abs5ce1 significant delay1 or discont9uation ( appropriate m$ical treatm5t1 ! ,secret>y %all issue an ord] requir+ ! appropriate p]son 7includ+ ! develop]s1 import]s1 di/ributors1 or retail]s ( ! 9 vitro cl9ical te/7-- 7,a7 to imm$iately cease di/ribution ( su* 9 vitro cl9ical te/2 & 7,b7 to imm$iately notify heal? pr(essionals & applicable 9 vitro cl9ical te/ us] facilities ( ! ord] & to in/ruct su* pr(essionals & facilities to cease use ( su* 9 vitro cl9ical te/4 7#b7 ,in=mal he>+ ,! ord] issu$ "u p>agraph 7#a77;,a71 %all provide ! p]son subject to ! ord] ) an opportunity = an in=mal he>+1 to be held n lat] ?an #aj cal5d> days aft] ! date ( ! issuance ( ! ord]1 on ! actions requir$ by ! ord] & on :e!r ! ord] %\ld be am5d$ to require a recall ( su* 9 vitro cl9ical te/4 ,if1 aft] provid+ an opportunity = su* a he>+1 ! ,secret>y det]m9es t inadequate gr\nds exi/ to support ! actions requir$ by ! ord]1 ! ,secret>y %all vacate ! ord]4 7#c7 ,am5d$ ord] 7,a7 ,9 g5]al ,if1 aft] provid+ an opportunity = an in=mal he>+ "u p>agraph 7#b71 ! ,secret>y det]m9es t ! ord] %\ld be am5d$ to include a recall ( ! 9 vitro cl9ical te/ ) respect to :i* ! ord] 0 issu$1 ! ,secret>y %all1 except z provid$ 9 subp>agraph 7,b71 am5d ! ord] to require a recall4 ,! ,secret>y %all specify a timetable 9 :i* ! recall w occur & %all require p]iodic reports describ+ ! progress ( ! recall4 7,b7 ,requirem5ts ,an am5d$ ord] "u subp>agraph 7,a7-- 7i7 %all n include recall ( ! 9 vitro cl9ical te/ f individuals2 7ii7 %all n include recall ( an 9 vitro cl9ical te/ f te/ us] facilities if ! ,secret>y det]m9es t ! risk ( recall+ su* 9 vitro cl9ical te/ f ! facilities pres5ts a great] heal? risk ?an ! heal? risk ( n recall+ ! 9 vitro cl9ical te/ f use2 & 7iii7 %all provide = notice to individuals subject to ! risks associat$ ) ! use ( su* 9 vitro cl9ical te/4 ,9 provid+ ! notice requir$ by ?is clause1 ! ,secret>y may use ! assi/ance ( heal? pr(essionals :o prescrib$1 ord]$1 or us$ su* an 9 vitro cl9ical te/ = individuals4 7#d7 ,cl>ification ,! rem$y provid$ by ?is subsection %all be 9 addition to rem$ies provid$ by subsections 7a71 7b71 & 7c74 #ehg;,,aa4 ,applicability 7a7 ,9 g5]al ,an 9 vitro cl9ical te/ %all be subject to ! requirem5ts ( ?is sub*apt]1 except z o!rwise provid$ 9 ?is sub*apt]4 ,laboratory op]ations %all n be subject to ! requirem5ts ( ?is sub*apt]4 7b7 ,int]/ate comm]ce ,any 9 vitro cl9ical te/ t is (f]$1 includ+ by mak+ available = cl9ical use 9 ! ,unit$ ,/ates is deem$ to be an act t con/itutes introduction into int]/ate comm]ce = purposes ( en=c+ ! requirem5ts ( ?is ,act4 7c7 ,lea/ burd5some requirem5ts 7#a7 ,9 g5]al ,9 c>ry+ out ?is sub*apt]1 ! ,secret>y %all consid] ! lea/ burd5some means necess>y to meet ! applicable /&>d1 & o!r regulatory requirem5ts1 z det]m9$ by ! ,secret>y4 7#b7 ,necess>y def9$ ,= purposes ( p>agraph 7#a71 ! t]m necess>y means ! m9imum requir$ in=mation t w\ld support a det]m9ation by ! ,secret>y t ! application meet ! applicable /&>d or regulatory requirem5t1 z det]m9$ by ! ,secret>y4 7d7 ,s]vice ( ord]s ,ord]s ( ! ,secret>y "u ?is section ) respect to applications "u subsection 7a7 or 7b7 ( section #ehg;,b or supplem5ts "u subsection 7f7 ( su* section %all be s]v$-- 7#a7 9 p]son by any (fic] or employee ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices designat$ by ! ,secret>y2 or 7#b7 by mail+ ! ord] by regi/]$ mail or c]tifi$ mail or electronic equival5t address$ to ! applicant at ! la/ kn[n address 9 ! records ( ! ,secret>y4 7e7 ,laboratories & blood & tissue e/abli%m5ts 7#a7 ,relation to laboratory c]tification pursuant to section #cec ( ! ,public ,heal? ,s]vice ,act ,no?+ 9 ?is sub*apt] %all be con/ru$ to modify ! au?ority ( ! ,secret>y ) respect to laboratories or cl9ical laboratories "u section #cec ( ! ,public ,heal? ,s]vice ,act4 7#b7 ,avoid+ duplication ,9 implem5t+ ?is sub*apt]1 ! ,secret>y %all avoid issu+ or en=c+ regulations or guidance t are duplicative ( regulations or guidance "u section #cec ( ! ,public ,heal? ,s]vice ,act su* t laboratories w\ld be subject to conflict+ regulatory obligations ) respect to ! same activity4 7#c7 ,blood & tissue ,no?+ 9 ?is sub*apt] %all be con/ru$ to modify ! au?ority ( ! ,secret>y ) respect to laboratories1 e/abli%m5ts1 or o!r facilities to ! ext5t !y are engag$ 9 ! propagation1 manufacture1 or prep>ation1 includ+ fill+1 label+1 packag+1 & /orage1 ( blood1 blood compon5ts1 human cells1 tissues1 or tissue products pursuant to any requirem5ts "u ?is ,act or section #cea or #cfa ( ! ,public ,heal? ,s]vice ,act4 7f7 ,n comb9ation product 7#a7 ,9 g5]al ,a product con/itut$ ( a device & an 9 vitro cl9ical te/ is n a comb9ation product & may be regulat$ z a device or z a device & 9 vitro cl9ical te/1 not)/&+ section #bja7ss77#c74 7#b7 ,guidance ,n lat] ?an ,octob] #a1 #bjbf1 ! ,secret>y %all issue f9al guidance1 aft] an opportunity = public comm5t1 address+ ! consid]ations = regulat+ a product describ$ 9 p>agraph 7#a74 ,su* guidance %all take into acc\nt ! lea/ burd5some requirem5ts "u subsection 7c74 7g7 ,practice ( m$ic9e ,no?+ 9 ?is sub*apt] %all be con/ru$ to limit or int]f]e ) ! au?ority ( a heal? c>e practition] to prescribe or adm9i/] any lawfully (f]$ 9 vitro cl9ical te/ = any condition or disease )9 a legitimate heal? c>e practition]-pati5t relation%ip pursuant to applicable ,f$]al or ,/ate law4 7h7 ,sale1 di/ribution1 label+ ,no?+ 9 ?is section %all be con/ru$ to limit ! au?ority ( ! ,secret>y to e/abli% or en=ce re/rictions on ! sale1 di/ribution1 or label+ ( an 9 vitro cl9ical te/ "u ?is ,act4 7i7 ,promotion ( unapprov$ uses ,no?+ 9 ?is section %all be con/ru$ to alt] any prohibition on ! promotion ( unapprov$ uses ( legally (f]$ 9 vitro cl9ical te/s4 7j7 ,volunt>y submissions ,no?+ 9 section #ehg;,c %all be con/ru$ to prev5t a develop] develop+ a te/ describ$ 9 su* section1 includ+ an academic m$ical c5t] laboratory describ$ 9 subsection 7a77#g7 ( su* section1 f fil+ an application "u section #ehg;,b or section #ehg;,d1 or f adh]+ to ! requirem5ts ( section #ehg,k ) reg>d to a te/ protocol describ$ 9 section #ehg,k or = any o!r te/ or use ( a te/4 #ehg;,,bb4 ,judicial review 7a7 ,9 g5]al ,n lat] ?an #cj days aft] an ord] issu$ pursuant to section #ehg;,b or #ehg;,d1 any p]son adv]sely affect$ by su* ord] may file a petition ) ! ,unit$ ,/ates ,c\rt ( ,appeals = ! ,di/rict ( ,columbia or = ! circuit :]e9 su* p]son resides or has a pr9cipal place ( bus9ess = judicial review ( su* ord]1 9 accordance ) ! proc$ure set =? 9 section #eag7;a74 7b7 ,application ( provisions ,subsections 7a7 ?r\gh 7e7 ( section #eag %all apply ) respect to a petition "u subsection 7a7 ( ?is section 9 ! same mann] su* subsections apply to a petition "u section #eag4 ,subsection 7f7 ( section #eag %all apply to an ord] issu$ "u section #ehg;,b or #ehg;,d4 4 #d4 ,en=cem5t & o!r provisions 7a7 ,prohibit$ acts ,section #cja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7 is am5d$-- 7#a7 9 p>agraphs 7a71 7b71 7c71 7g71 7h71 7k71 7q71 7r71 & 7y71 by ins]t+ 9 vitro cl9ical te/1 aft] device1 ea* place x appe>s2 7#b7 9 p>agraph 7g71 by ins]t+ aft] misbr&$ ! foll[+3 1 & ! developm5t )9 any ,t]ritory ( any 9 vitro cl9ical te/ t is adult]at$ or misbr&$2 7#c7 9 p>agraph 7y71 by ins]t+ or #ehg,q aft] section #ebc ea* place x appe>s2 7#d7 9 p>agraph 7ff71 by /rik+ or device & ins]t+ 1 device1 or 9 vitro cl9ical te/2 & 7#e7 by add+ at ! end1 ! foll[+3 7fff7 7#a7 ,=g+1 c\nt]feit+1 simulat+1 or falsely repres5t+1 or )\t prop] au?ority us+ any m>k1 /amp1 tag1 label1 or o!r id5tification ^u any 9 vitro cl9ical te/ or conta9]1 packag+1 or label+ !re( s z to r5d] su* 9 vitro cl9ical te/ a c\nt]feit 9 vitro cl9ical te/4 7#b7 ,mak+1 sell+1 dispos+ (1 or keep+ 9 possession1 control1 or cu/ody1 or conceal+ any pun*1 die1 plate1 /one1 or o!r ?+ design$ to pr9t1 impr9t1 or reproduce ! tradem>k1 trade "n1 or o!r id5tify+ m>k or impr9t ( ano!r or any lik5ess ( any ( ! =ego+ ^u any 9 vitro cl9ical te/ or conta9]1 packag+1 or label+ !re( s z to r5d] su* 9 vitro cl9ical te/ a c\nt]feit 9 vitro cl9ical te/4 7#c7 ,! do+ ( any act :i* causes an 9 vitro cl9ical te/ to be a c\nt]feit 9 vitro cl9ical te/1 or ! sale or disp5s+1 or ! hold+ = sale or disp5s+1 ( a c\nt]feit 9 vitro cl9ical te/4 7ggg7 7#a7 ,! introduction or deliv]y = introduction into int]/ate comm]ce ( an 9 vitro cl9ical te/ 9 violation ( section #ehg;,a7a74 7#b7 ,! mak+ ( a false1 fraudul5t1 or deceptive /atem5t ab\t an 9 vitro cl9ical te/ t is exempt f prem>ket review "u section #ehg;,c4 7#c7 ,! failure to ma9ta9 complete & accurate docum5tation = an exemption z requir$ "u section #ehg;,c or ! failure to provide label+ requir$ "u section #ehg,l4 7#d7 ,) respect to an 9 vitro cl9ical te/1 ! submission ( any application1 report1 or li/+ "u ?is ,act t is false or mislead+ 9 any mat]ial respect4 7#e7 ,! failure to comply ) a condition ( approval1 or re/riction requir$ "u an approv$ application "u section #ehg;,b2 ! failure to p]=m a risk analysis requir$ by section #ehg;,b2 ! failure to submit an annual update requir$ "u section #ehg;,j7c77#b77;,b72 or ! failure to complete po/m>ket surveillance z requir$ "u section #ehg,x4 7#f7 ,! failure to comply ) applicable requirem5ts to submit an application or report "u section #ehg;,d7e74 7#g7 ,! failure to comply ) applicable mitigat+ measures e/abli%$ "u section #ehg;,e or to submit1 ma9ta91 or make available ! docum5tation requir$ "u section #ehg;,e7b72 or ! failure to comply ) applicable p]=mance /&>ds e/abli%$ "u section #ehg,r4 7#h7 ,! failure to regi/] 9 accordance ) section #ehg;,j1 ! failure to provide in=mation requir$ "u section #ehg;,j7b71 or ! failure to ma9ta9 or submit in=mation requir$ "u section #ehg;,j7c74 7#i7 ,! failure to comply ) requirem5ts "u section #ehg,m or #ehg,n1 ! failure to comply ) a re/riction requir$ "u section #ehg,o1 or ! failure to comply ) label+ & adv]tis+ requirem5ts "u section #ehg,o7b74 7#aj7 ,! failure to comply ) ! requirem5ts ( section #ehg,q4 7#aa7 ,! failure to comply ) any requirem5t ( section #ehg,s2 ! failure to furni% any notification1 in=mation1 mat]ial1 or report requir$ "u section #ehg,s2 or ! failure to comply ) an ord] issu$ "u section #ehg,s4 7#ab7 ,! failure to furni% in=mation reque/$ by ! ,secret>y "u #ehg;,g7d77#b74 4 7b7 ,p5alties ,section #cjc ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7 is am5d$-- 7#a7 9 subsection 7b77#h71 by ins]t+ or c\nt]feit 9 vitro cl9ical te/ aft] c\nt]feit drug2 7#b7 9 subsection 7c7-- 7,a7 by /rik+ 2 or 7#e7 & ins]t+ 2 7#e72 & 7,b7 by ins]t+ be=e ! p]iod at ! end ! foll[+3 2 or 7#f7 = hav+ violat$ section #cja7;fff77#b7 if su* p]son act$ 9 good fai? & _h no reason to believe t use ( ! pun*1 die1 plate1 /one1 or o!r ?+ involv$ w\ld result 9 an 9 vitro cl9ical te/ be+ a c\nt]feit 9 vitro cl9ical te/1 or = hav+ violat$ section #cja7;fff77#c7 if ! p]son do+ ! act or caus+ x to be done act$ 9 good fai? & _h no reason to believe t ! 9 vitro cl9ical te/ 0 a c\nt]feit 9 vitro cl9ical te/2 & 7#c7 9 subsection 7f77#a7-- 7,a7 9 subp>agraph 7,a7-- 7i7 by ins]t+ or 9 vitro cl9ical te/s aft] :i* relates to devices2 7ii7 by ins]t+ or section #ehg,q7a77#a7 aft] section #gjd7;g72 & 7iii7 by ins]t+ or 9 vitro cl9ical te/s1 z applicable be=e ! p]iod at ! end ( ! second s5t5ce2 & 7,b7 9 subp>agraph 7,b77i71 by /rik+ or #ebj7;f7 & ins]t+ 1 #ebj7;f71 #ehg,k1 or #ehg,m14 7c7 ,seizure ,section #cjd ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ccd7 is am5d$-- 7#a7 9 subsection 7a77#b7-- 7,a7 by /rik+ 1 & 7,e7 & ins]t+ 1 7,e72 & 7,b7 by ins]t+ be=e ! p]iod at ! end ! foll[+3 1 & 7,f7 ,any 9 vitro cl9ical te/ t is a c\nt]feit 9 vitro cl9ical te/1 7,g7 ,any conta9]1 packag+1 or label+ ( a c\nt]feit 9 vitro cl9ical te/1 & 7,h7 ,any pun*1 die1 plate1 /one1 label+1 conta9]1 or o!r ?+ us$ or design$ = use 9 mak+ a c\nt]feit 9 vitro cl9ical te/2 7#b7 9 subsection 7d77#a71 by ins]t+ 9 vitro cl9ical te/1 aft] device12 & 7#c7 9 subsection 7g7-- 7,a7 9 p>agraph 7#a71 by ins]t+ 1 9 vitro cl9ical te/1 aft] device ea* place x appe>s2 & 7,b7 9 p>agraph 7#b7-- 7i7 9 subp>agraph 7,a71 by ins]t+ 1 9 vitro cl9ical te/1 aft] device2 & 7ii7 9 subp>agraph 7,b71 by ins]t+ or 9 vitro cl9ical te/ aft] device ea* place x appe>s4 7d7 ,deb>m5t1 tempor>y d5ial ( approval1 & susp5sion ,section #cjf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cce;a7 is am5d$ by add+ at ! end ! foll[+3 7n7 ,9 vitro cl9ical te/s2 m&atory deb>m5t reg>d+ ?ird-,p>ty inspections & reviews 7#a7 ,9 g5]al ,if ! ,secret>y f9ds t a p]son has be5 convict$ ( a felony = a violation ( section #cja7;gg7 or #cja7;fff77#a71 ! ,secret>y %all deb> su* p]son f be+ accr$it$ "u section #ehg,q & f c>ry+ out activities "u an agreem5t describ$ 9 section #hjc7;b74 7#b7 ,deb>m5t p]iod ,! ,secret>y %all deb> a p]son "u p>agraph 7#a7 = ! foll[+ p]iods3 7,a7 ,! p]iod ( deb>m5t ( a p]son 7o!r ?an an individual7 %all n be less ?an #a ye> or m ?an #aj ye>s1 b if an act lead+ to a subsequ5t deb>m5t "u su* p>agraph occurs )9 #aj ye>s aft] su* p]son has be5 deb>r$ "u su* p>agraph1 ! p]iod ( deb>m5t %all be p]man5t4 7,b7 ,! deb>m5t ( an individual %all be p]man5t4 7#c7 ,t]m9ation ( deb>m5t2 judicial review2 o!r matt]s ,subsections 7c77#c71 7d71 7e71 7i71 7j71 & 7l77#a7 apply ) respect to a p]son 7o!r ?an an individual7 or an individual :o is deb>r$ "u p>agraph 7#a7 to ! same ext5t & 9 ! same mann] z su* subsections apply ) respect to a p]son :o is deb>r$ "u subsection 7a77#a71 or an individual :o is deb>r$ "u subsection 7a77#b71 respectively4 4 7e7 ,exp&$ access to unapprov$ !rapies & diagno/ics ,section #efa ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb7 is am5d$-- 7#a7 9 subsections 7a7 ?r\gh 7d7-- 7,a7 by /rik+ or inve/igational devices ea* place x appe>s & ins]t+ 1 inve/igational devices1 or inve/igational 9 vitro cl9ical te/s2 & 7,b7 by /rik+ or inve/igational device ea* place x appe>s 7o!r ?an ! second su* place 9 p>agraph 7#c77;,a77 ( subsection 7c77 & ins]t+ 1 inve/igational device1 or inve/igational 9 vitro cl9ical te/2 7#b7 9 subsection 7b77#d7 by /rik+ or #ebj7;g7 ea* place x appe>s & ins]t+ 1 #ebj7;g71 or #ehg,s2 7#c7 9 subsection 7c7-- 7,a7 by am5d+ ! subsection head+ to read3 ,treatm5t ,inve/igational ,new ,drug ,applications1 ,treatm5t ,inve/igational ,device ,exemptions1 & ,treatm5t ,inve/igational 9 ,vitro ,cl9ical ,te/ ,exemptions42 7,b7 9 p>agraph 7#c77;,a71 by /rik+ or inve/igational device exemption 9 effect "u section #ebj7;g7 & ins]t+ 1 inve/igational device exemption 9 effect "u section #ebj7;g71 or inve/igational 9 vitro cl9ical te/ exemption "u section #ehg,s2 7,c7 by /rik+ or treatm5t inve/igational device exemption ea* place x appe>s & ins]t+ 1 treatm5t inve/igational device exemption1 or treatm5t inve/igational 9 vitro cl9ical te/ exemption2 7,d7 9 p>agraph 7#e71 by /rik+ or #ebj7;g7 & ins]t+ 1 #ebj7;g71 or #ehg,s2 & 7,e7 9 ! matt] foll[+ p>agraph 7#g7 by /rik+ or #ebj7;g7 ea* place x appe>s & ins]t+ 1 #ebj7;g71 or #ehg,s2 & 7#d7 by am5d+ subsection 7e7 to read z foll[s3 7e7 ,def9itions ,9 ?is section1 ! t]ms inve/igational drug1 inve/igational device1 inve/igational 9 vitro cl9ical te/1 treatm5t inve/igational new drug application1 treatm5t inve/igational device exemption1 & treatm5t inve/igational 9 vitro cl9ical te/ exemption %all h ! mean+s giv5 ! t]ms 9 regulations prescrib$ by ! ,secret>y4 4 7f7 ,optimiz+ global cl9ical trials ,section #efi;,a7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#h;a7b77 is am5d$-- 7#a7 by /rik+ subsection ea* place x appe>s & ins]t+ p>agraph2 & 7#b7 by ins]t+ an 9 vitro cl9ical te/1 z def9$ 9 p>agraph 7ss7 ( su* section1 be=e or a biological product4 7g7 ,pati5t p>ticipation 9 m$ical product discussion ,! head+ ( subsection 7a7 ( section #efi;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#h;c7 is am5d$ by /rik+ drugs & devices & ins]t+ drugs1 devices1 & 9 vitro cl9ical te/s4 7h7 ,regulations & he>+s ,clause 7ii7 ( section #gja7;h77#a77;,c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cga7;h77#a77;,c77 is am5d$-- 7#a7 by ins]t+ & 9 vitro cl9ical te/s aft] devices2 & 7#b7 by mov+ ! m>g9 ( su* clause #b ems to ! left4 7i7 ,records ,section #gjc ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgc7 is am5d$-- 7#a7 by ins]t+ 9 vitro cl9ical te/s1 aft] devices1 ea* place su* t]m appe>s2 & 7#b7 by ins]t+ 9 vitro cl9ical te/1 aft] device1 ea* place su* t]m appe>s4 7j7 ,factory inspection ,section #gjd ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7 7o!r ?an subsection 7g77 is am5d$-- 7#a7 by /rik+ drugs or devices ea* place x appe>s & ins]t+ drugs1 devices1 or 9 vitro cl9ical te/s2 7#b7 9 subsection 7a77#a71 9 ! f\r? s5t5ce1 by /rik+ or *apt] ,,ix & ins]t+ section #ehg,s1 section #ehg,m1 section #ehg,n1 or *apt] ,,ix2 7#c7 aft] mak+ ! am5dm5ts 9 p>agraphs 7#a7 & 7#b71 by ins]t+ 9 vitro cl9ical te/s1 aft] devices1 ea* place x appe>s2 7#d7 9 subsection 7a77#b77;,b7-- 7,a7 by ins]t+ or 9 vitro cl9ical te/s aft] prescribe or use devices2 & 7,b7 by ins]t+ or 9 vitro cl9ical te/s aft] process devices2 7#e7 by ins]t+ 9 vitro cl9ical te/1 aft] device1 ea* place x appe>s2 7#f7 9 subsection 7e71 by ins]t+ 1 or section #ehg,m1 #ehg,n1 or #ehg,s1 aft] section #eai or #ebj7;g72 7#g7 9 subsection 7f77#c7-- 7,a7 9 subp>agraph 7,a71 by /rik+ or at ! end2 7,b7 9 subp>agraph 7,b71 by /rik+ ! p]iod at ! end & ins]t+ 2 or2 & 7,c7 aft] subp>agraph 7,b71 by ins]t+ ! foll[+3 7,c7 is accr$it$ "u section #ehg,q4 2 & 7#h7 by add+ at ! end ! foll[+3 7i7 ,= purposes ( ?is section1 ! t]m e/abli%m5t includes a laboratory p]=m+ an 9 vitro cl9ical te/4 4 7k7 ,publicity ,section #gje7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cge7;b77 is am5d$ by ins]t+ 9 vitro cl9ical te/s1 aft] devices14 7l7 ,presumption ,section #gji ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;a7 is am5d$ by ins]t+ 9 vitro cl9ical te/1 aft] device14 7m7 ,li/+ & c]tification ( color additives = foods1 drugs1 & cosmetics ,section #gba7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;e7a77 is am5d$-- 7#a7 9 ! matt] prec$+ p>agraph 7#a71 by ins]t+ or 9 vitro cl9ical te/s aft] or devices2 & 7#b7 9 ! flu% text foll[+ p>agraph 7#b7-- 7,a7 by ins]t+ or an 9 vitro cl9ical te/ aft] a device2 & 7,b7 by ins]t+ or 9 vitro cl9ical te/s aft] devices4 7n7 ,imports & exports ,section #hja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 by ins]t+ 9 vitro cl9ical te/s1 aft] devices1 ea* place x appe>s2 & 7,b7 by ins]t+ 9 ! case ( an 9 vitro cl9ical te/1 ! te/ does n con=m to ! applicable requirem5ts ( section #ehg,k1 or aft] requirem5ts ( section #ebj7;f71 or2 7#b7 9 subsection 7d77#c7-- 7,a7 9 subp>agraph 7,a7-- 7i7 9 ! matt] prec$+ clause 7i71 by ins]t+ & no compon5t ( an 9 vitro cl9ical te/ or o!r article ( 9 vitro cl9ical te/ t requires fur!r process+1 aft] heal?-relat$ purposes2 7ii7 9 clause 7i71 by /rik+ drug or device & ins]t+ drug1 device1 or 9 vitro cl9ical te/2 & 7iii7 9 clause 7i77,i71 by ins]t+ 9 vitro cl9ical te/1 aft] device12 & 7,b7 9 subp>agraph 7,b71 by ins]t+ 9 vitro cl9ical te/1 aft] device12 7#c7 9 subsection 7e77#a71 by ins]t+ 9 vitro cl9ical te/1 aft] device12 & 7#d7 9 subsection 7o7-- 7,a7 by ins]t+ or 9 vitro cl9ical te/ aft] device2 & 7,b7 by ins]t+ 1 or "u section #ehg;,j ( ea* =eign e/abli%m5t1 aft] section #eaj7;i7 ( ea* e/abli%m5t4 7o7 ,(fice ( int]national relations ,section #hjc ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #chc7 is am5d$-- 7#a7 9 subsection 7b7-- 7,a7 9 ! matt] prec$+ p>agraph 7#a71 by ins]t+ & 9 vitro cl9ical te/s aft] devices2 & 7,b7 9 p>agraph 7#a71 by /rik+ 1 & & ins]t+ & quality requirem5ts e/abli%$ "u section #ehg,k2 &2 & 7#b7 9 subsection 7c7-- 7,a7 9 p>agraph 7#b71 by ins]t+ 9 vitro cl9ical te/s1 aft] devices12 & 7,b7 9 p>agraph 7#d71 by ins]t+ or 9 vitro cl9ical te/s aft] devices4 7p7 ,recognition ( =eign gov]nm5t inspections ,section #hji7;a77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #chd;e7a77#a77 is am5d$ by ins]t+ 1 or ( =eign e/abli%m5ts regi/]$ "u section #ehg;,j1 aft] #eaj7;h74 7q7 ,food & drug adm9i/ration ,section #ajjc7;b77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cic7;b77#b77 is am5d$-- 7#a7 9 subp>agraph 7,d71 by /rik+ & at ! end2 7#b7 9 subp>agraph 7,e71 by /rik+ ! semicolon at ! end & ins]t+ 2 &2 & 7#c7 by add+ at ! end ! foll[+3 7,f7 9 vitro cl9ical te/s are analytically & cl9ically valid2 4 7r7 ,(fice ( wom5's heal? ,section #ajaa7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cii;b7b77 is am5d$-- 7#a7 9 p>agraph 7#a71 by ins]t+ 9 vitro cl9ical te/s1 aft] devices12 & 7#b7 9 p>agraph 7#d71 by ins]t+ 9 vitro cl9ical te/ develop]s1 aft] device manufactur]s14 7s7 ,c\nt]measure provisions ( ! public heal? s]vice act ,title ,,iii ( ! ,public ,heal? ,s]vice ,act is am5d$-- 7#a7 9 section #cai;,f-#a7;a77#b77;,a7 7#db ,u4,s4,c4 #bdg;d-#f;a7a77#b77;,a77-- 7,a7 9 ! matt] prec$+ clause 7i7-- 7i7 by /rik+ or device & ins]t+ device2 & 7ii7 by ins]t+ or an 9 vitro cl9ical te/s 7z t t]m is def9$ 9 section #bja7ss7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7ss7771 aft] ,act 7#ba ,u4,s4,c4 #cba7;h77712 & 7,b7 9 ea* ( clauses 7ii7 & 7iii71 by /rik+ or device & ins]t+ device1 or 9 vitro cl9ical te/2 7#b7 9 section #cai;,f-#b7;c77#a77;,b7 7#db ,u4,s4,c4 #bdg;d-#f;b7c77#a77;,b77-- 7,a7 by /rik+ or device & ins]t+ device2 & 7,b7 by ins]t+ 1 or an 9 vitro cl9ical te/ 7z t t]m is def9$ 9 section #bja7ss7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7ss777 aft] ,act 7#ba ,u4,s4,c4 #cba7;h77712 & 7#c7 9 section #cai;,f-#c7;i77#g7 7#db ,u4,s4,c4 #bdg;d-#f;d7i77#g77-- 7,a7 9 ! matt] prec$+ subp>agraph 7,a7-- 7i7 by /rik+ or device & ins]t+ device2 & 7ii7 by ins]t+ or an 9 vitro cl9ical te/s 7z t t]m is def9$ 9 section #bja7ss7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7ss7771 aft] ,act 7#ba ,u4,s4,c4 #cba7;h772 7,b7 9 subp>agraph 7,a7-- 7i7 by mov+ ! m>g9 ( clause 7iii7 #b ems to ! left2 & 7ii7 9 clause 7iii71 by /rik+ or device & ins]t+ device1 or 9 vitro cl9ical te/2 & 7,c7 9 subp>agraph 7,b7-- 7i7 9 clause 7i71 by /rik+ approv$ or cle>$ & ins]t+ approv$1 cle>$1 or (f]$ "u a te*nology c]tification ord]2 & 7ii7 9 clause 7ii71 by /rik+ or #ebj7;g7 & ins]t+ 1 #ebj7;g71 or #ehg,s4 #e4 ,transition 7a7 ,implem5tation 7#a7 ,effective date 7,a7 ,9 g5]al ,except z o!rwise provid$ 9 ?is section1 ! am5dm5ts made by ?is ,act %all take effect on ,octob] #a1 #bjbh 79 ?is section & 9 sub*apt] ,j ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by ?is ,act1 ref]r$ to 9 ?is section z ! effective date ( ?is ,act74 7,b7 ,exceptions 7i7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is section ref]r$ to z ! ,secret>y7 may take ! actions describ$ 9 p>agraph 7#b71 & may exp5d su* funds z ! ,secret>y det]m9es necess>y to ensure an ord]ly transition prior to ! effective date ( ?is ,act4 7ii7 ,implem5tation ( c]ta9 provisions ,! ,secret>y may implem5t sections #ehg;,j & #ehg,u ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z add$ by section #c7 beg9n+ on ,octob] #a1 #bjbd1 & su* sections may take effect n e>li] ?an ,octob] #a1 #bjbh1 to ! ext5t & = ! purposes indicat$ 9 su* sections4 ,9 ! case ( a develop] :o1 betwe5 ,octob] #a1 #bjbd1 & ! effective date ( ?is ,act1 regi/]s "u su* section #ehg;,j ) respect to an article t is an 9 vitro cl9ical te/1 su* develop] %all n be requir$ to regi/] ) respect to su* article "u section #eaj ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj74 7#b7 ,actions ,! ,secret>y-- 7,a7 %all-- 7i7 )9 #a ye> ( ! date ( enactm5t ( ?is ,act1 hold ! public meet+s describ$ 9 section #ehg;,d7i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z add$ by section #c72 & 7ii7 )9 #c ye>s ( ! date ( enactm5t ( ?is ,act1 promulgate f9al regulations requir$ "u ! am5dm5ts made by ?is ,act2 & 7,b7 may take additional actions aft] ! date ( enactm5t t ! ,secret>y det]m9es necess>y to ensure an ord]ly transition1 includ+-- 7i7 e/abli%m5t ( mitigat+ measures = an 9 vitro cl9ical te/ or category ( 9 vitro cl9ical te/s1 :i* may n take effect until aft] ! effective date describ$ 9 p>agraph 7#a77;,a72 & 7ii7 e/abli%m5t ( ! compreh5sive te/ in=mation sy/em "u section #ehg,t ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #c4 7#c7 ,applicability ( guidance & regulations ,not)/&+ ! date on :i* guidance or regulations are issu$ "u p>agraph 7#b7 & section #ehg,k ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #c1 no guidance or regulations issu$ pursuant to ! am5dm5ts made by ?is ,act %all be implem5t$ or take effect until ! effective date ( ?is ,act1 except z o!rwise specifi$ 9 ?is ,act 7includ+ ! am5dm5ts made by ?is ,act74 7#d7 ,implem5tation requirem5ts ,9 ! ev5t t ! ,secret>y fails to promulgate ! regulations requir$ "u section #ehg;,b7a77#d71 #ehg;,d7j71 or #ehg,s7b77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #c1 by ! deadl9e describ$ 9 subsection 7a77#b77;,a77ii71 ! ,secret>y %all1 )9 #ae days ( su* miss$ deadl9e-- 7,a7 submit a report to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives provid+ in=mation relat$ to ! /atus ( su* regulations1 includ+-- 7i7 a rationale = miss+ ! applicable deadl9e describ$ 9 su* subsection2 7ii7 a description ( actions tak5 to ! date ( submission ( ! report to promulgate ea* su* regulations2 7iii7 ! expect$ timel9e = promulgat+ ea* su* regulations2 7iv7 an assessm5t ( ! impact ( ! delay 9 promulgat+ su* regulations on develop]s ( 9 vitro cl9ical te/s1 includ+ an economic assessm5t2 & 7v7 an assessm5t ( ! impact ( ! delay 9 promulgat+ su* regulations on pati5ts2 & 7,b7 op5 a public docket = purposes ( solicit+ public comm5ts on ! impact ( ! delay 9 promulgat+ su* regulations4 7b7 ,application ( au?orities to 9 vitro cl9ical te/s "u review on ! effective date ( ?is act ,= any 9 vitro cl9ical te/ = :i* a submission = approval "u section #eae ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e71 cle>ance "u section #eaj7k7 ( su* ,act 7#ba ,u4,s4,c4 #cfj7k771 au?orization "u section #eac7;f77#b7 ( su* ,act 7#ba ,u4,s4,c4 #cfj;c7f77#b771 or lic5sure "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 is p5d+ on ! effective date ( ?is ,act1 includ+ transitional 9 vitro cl9ical te/s z describ$ 9 subsection 7c71 ! ,secret>y may review & take action on su* submission aft] ! effective date ( ?is ,act accord+ to ! /atutory provision "u :i* su* submission 0 submitt$4 7c7 ,application ( au?orities to transitional ,9 vitro cl9ical te/s 7#a7 ,def9ition ,= purposes ( ?is section1 ! t]m transitional 9 vitro cl9ical te/ means an 9 vitro cl9ical te/ t-- 7,a7 7i7 is fir/ (f]$ = cl9ical use dur+ ! p]iod beg9n+ on ! date t is #de days aft] ! date ( enactm5t ( ?is ,act & end+ on ! effective date ( ?is ,act2 or 7ii7 is (f]$ solely = inve/igational use dur+ ! p]iod beg9n+ on ! date ( enactm5t ( ?is ,act & end+ on ! effective date ( ?is ,act2 7,b7 is develop$ by a cl9ical laboratory c]tifi$ by ! ,secret>y "u section #cec ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfc;a7 t meets ! requirem5ts = p]=m+ high-complexity te/+ & p]=m$-- 7i7 9 ! same cl9ical laboratory 9 :i* ! te/ 0 develop$ & = :i* a c]tification is /ill 9 effect "u su* section #cec t meets ! requirem5ts to p]=m te/s ( high complexity2 7ii7 by ano!r laboratory = :i* a c]tificate is 9 effect "u su* section #cec t meets ! requirem5ts to p]=m te/s ( high complexity1 is )9 ! same corporate organization1 & has common own]%ip by ! same p>5t corporation z ! laboratory 9 :i* ! te/ 0 develop$2 or 7iii7 9 ! case ( a te/ t 0 develop$ by ! ,c5t]s = ,disease ,control & ,prev5tion or ano!r laboratory 9 a public heal? laboratory network coord9at$ or manag$ by ! ,c5t]s = ,disease ,control & ,prev5tion1 by a cl9ical laboratory = :i* a c]tificate is 9 effect "u su* section #cec t meets ! requirem5ts to p]=m te/s ( high complexity1 & t is )9 a public heal? laboratory network coord9at$ or manag$ by ! ,c5t]s = ,disease ,control & ,prev5tion2 & 7,c7 :5 fir/ (f]$1 is n approv$ "u section #eae ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 cle>$ "u section #eaj7k7 ( su* ,act1 au?oriz$ "u section #eac7;f77#b7 ( su* ,act1 subject to a humanit>ian device exemption "u section #ebj7m7 ( su* ,act 7#ba ,u4,s4,c4 #cfj;j7m771 subject to an exemption = inve/igation use "u section #ebj7;g7 ( su* ,act 7#ba ,u4,s4,c4 #cfj;j7g771 au?oriz$ "u section #efd ( su* ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c71 or lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb74 7#b7 ,prem>ket review or te*nology c]tification ,a transitional 9 vitro cl9ical te/ t is n exempt f prem>ket review "u section #ehg;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #c1 may cont9ue to be (f]$1 sold1 or di/ribut$1 z applicable1 )\t m>ket+ au?orization until completion ( ! ,secret>y's review ( ! prem>ket application or te*nology c]tification application "u section #ehg;,b or #ehg;,d1 z applicable1 if-- 7,a7 su* 9 vitro cl9ical te/ is a high-risk te/ 7z def9$ 9 section #ehg ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #c7 & ! application = su* te/ is submitt$ n lat] ?an #ij days aft] ! effective date ( ?is ,act2 or 7,b7 su* 9 vitro cl9ical te/ is a mod]ate-risk te/ 7z def9$ 9 su* section #ehg71 ! develop] li/s ! te/ 9 accordance ) section #ehg;,j )9 #aj cal5d> days ( ! effective date ( ?is sub*apt]1 & ! application = su* te/ is submitt$ n lat] ?an #a ye> aft] ! effective date ( ?is ,act4 7#c7 ,inve/igational use reque/ ,a transitional 9 vitro cl9ical te/ describ$ 9 p>agraph 7#a77;,a77ii7 t is us$ 9 a significant risk inve/igation may cont9ue to be (f]$ = inve/igational use until completion ( ! ,secret>y's review ( an application "u #ehg,s1 if su* application is submitt$ n lat] ?an #ij days aft] ! effective date ( ?is ,act4 7#d7 ,te/s approv$ by ,new ,york ,/ate ,not)/&+ p>agraph 7#b71 a transitional 9 vitro cl9ical te/ t has be5 approv$ by ! ,new ,york ,/ate ,dep>tm5t ( ,heal? may cont9ue to be (f]$1 sold1 or di/ribut$1 z applicable1 aft] ! effective date if-- 7,a7 />t+ on ! effective date ( ?is ,act1 ! 9 vitro cl9ical te/ complies ) ! requirem5ts ( sub*apt] ,j ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by ?is ,act1 except = section #ehg;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #c1 & design control provisions ( section #ehg,k ( su* ,act2 7,b7 ea* te/ report = ! te/ be>s a /atem5t ( adequate prom95ce t reads z foll[s3 ,?is 9 vitro cl9ical te/ 0 develop$ & fir/ introduc$ prior to ! effective date ( ! ,,valid ,act ( #bjbc4 ,?is te/ 0 approv$ by ! ,new ,york ,/ate ,dep>tm5t ( ,heal?1 b ! te/ has n be5 review$ by ! ,food & ,drug ,adm9i/ration42 7,c7 a prem>ket application "u section #ehg;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #c1 or te*nology c]tification application "u section #ehg;,d ( su* ,act1 z add$ by section #c1 is submitt$ no lat] ?an-- 7i7 #e ye>s aft] ! effective date ( ?is ,act1 if ! 9 vitro cl9ical te/ is approv$ by ! ,new ,york ,/ate ,dep>tm5t ( ,heal? z a g5etic te/+ molecul> te/1 a microbiology molecul> te/1 an oncology molecul> te/1 or any o!r type ( molecul> te/2 or 7ii7 #b ye>s aft] ! effective date ( ?is ,act1 if ! 9 vitro cl9ical te/ is approv$ by ! ,new ,york ,/ate ,dep>tm5t ( ,heal? z a type ( te/ n describ$ 9 clause 7i72 & 7,d7 a te/ 9 compliance ) ?is p>agraph may cont9ue to be (f]$1 sold1 or di/ribut$1 z applicable1 until ! completion ( ! ,secret>y's review ( ! prem>ket application or te*nology c]tification application describ$ 9 subp>agraph 7,c74 7d7 ,conv]sion 7#a7 ,deem$ prem>ket approval ,beg9n+ on ! effective date ( ?is ,act-- 7,a7 any 9 vitro cl9ical te/ ) a prem>ket approval "u section #eae ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e7 or a lic5sure "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 is deem$ to be approv$ pursuant to an application "u section #ehg;,b7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by ?is ,act2 & 7,b7 any 9 vitro cl9ical te/ 7z s def9$7 t 0 cle>$ "u section #eaj7k7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7k77 or au?oriz$ "u section #eac7;f77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;c7f77#b77 is deem$ to be approv$ pursuant to an application "u section #ehg;,b7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by ?is ,act4 7#b7 ,deem$ inve/igational use exemption ,any 9 vitro cl9ical te/ t has an inve/igational device exemption 9 effect "u section #ebj7;g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7g77 is deem$ to h an inve/igational use exemption 9 effect "u section #ehg,s ( su* ,act1 z add$ by ?is ,act1 beg9n+ on ! effective date ( ?is ,act4 7#c7 ,deem$ humanit>ian device exemption ,any 9 vitro cl9ical te/ t has an approv$ humanit>ian device exemption "u section #ebj7m7 ( su* ,act is deem$ to h a humanit>ian te/ exemption "u section #ehg;,a7g7 ( su* ,act1 z add$ by ?is ,act1 beg9n+ on ! effective date ( ?is ,act4 7#d7 ,deem$ designat$ break?r\gh ,any 9 vitro cl9ical te/ t has receiv$ a break?r\gh device designation "u section #eae;,b7e77#a77;,d7 ( su* ,act 7#ba ,u4,s4,c4 #cfj;e-#c7;e77#a77;,d77 is deem$ to h a break?r\gh 9 vitro cl9ical te/ designation "u section #ehg;,c ( su* ,act1 z add$ by ?is ,act1 beg9n+ on ! effective date ( ?is ,act4 7#e7 ,deem$ reque/ = in=mal fe$back ,) reg>d to any 9 vitro cl9ical te/ t is ! subject ( a pre-submission reque/ describ$ 9 ! guidance1 ,reque/s = ,fe$back & ,meet+s = ,m$ical ,device ,submissions3 ,! ,q-,submission ,program1 issu$ by ! ,food & ,drug ,adm9i/ration on ,janu>y #f1 #bjba1 su* reque/ is deem$ to con/itute a reque/ = in=mal fe$back "u section #ehg;,f ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #c1 beg9n+ on ! effective date ( ?is ,act4 7e7 ,previ\sly classifi$ devices ,not)/&+ section #ehg ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #c1 = purposes ( sub*apt] ,j ( *apt] ,v ( su* ,act1 z add$ by section #c1 ! foll[+ apply3 7#a7 ,9 ! case ( an 9 vitro cl9ical te/ type t has be5 classifi$ by ! ,secret>y z a class ,i device pursuant to section #eac ( su* ,act 7#ba ,u4,s4,c4 #cfj;c71 su* 9 vitro cl9ical te/ %all be l[-risk1 unless ! 9 vitro cl9ical te/ is a te/ describ$ 9 ! second s5t5ce ( section #eaj7l77#a7 ( su* ,act or ! te/ is r$esignat$ by ! ,secret>y pursuant to section #ehg;,f ( su* ,act4 7#b7 ,9 ! case ( an 9 vitro cl9ical te/ type t has be5 classifi$ by ! ,secret>y z a class ,,ii device pursuant to section #eac ( su* ,act 7#ba ,u4,s4,c4 #cfj;c71 su* 9 vitro cl9ical te/ %all be mod]ate-risk1 unless inaccurate results f ! te/ w\ld be imm$iately life ?reat5+ or ! te/ is r$esignat$ by ! ,secret>y pursuant to section #ehg;,f ( su* ,act4 7#c7 ,9 ! case ( an 9 vitro cl9ical te/ type t has be5 classifi$ by ! ,secret>y z a class ,,iii device pursuant to section #eac ( su* ,act 7#ba ,u4,s4,c4 #cfj;c7 or an 9 vitro cl9ical te/ lic5s$ pursuant to section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb71 su* 9 vitro cl9ical te/ %all be high-risk1 unless r$esignat$ by ! ,secret>y pursuant to section #ehg;,f ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act4 #f4 ,em]g5cy use au?orization 7a7 ,9 g5]al ,section #efd ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c7 is am5d$-- 7#a7 by ins]t+ or develop] aft] manufactur]1 ea* place su* t]m appe>s2 7#b7 9 subsection 7a7-- 7,a7 9 p>agraphs 7#a7 & 7#d77;,c71 by ins]t+ 9 vitro cl9ical te/1 be=e or biological product ea* place su* t]m appe>s2 7,b7 9 p>agraph 7#b77;,a71 by /rik+ or #eae & ins]t+ #eae1 or #ehg;,b2 & 7,c7 by add+ at ! end ! foll[+3 7,f7 ,! t]ms develop & develop]1 ) respect to an 9 vitro cl9ical te/1 h ! mean+s giv5 su* t]ms 9 section #ehg4 2 7#c7 9 subsection 7b71 by ins]t+ or develop] aft] manufactur] ea* place su* t]m appe>s2 7#d7 9 subsection 7e7-- 7,a7 by ins]t+ or develop]s aft] manufactur]s ea* place su* t]m appe>s2 7,b7 9 p>agraph 7#b77;,b77ii71 by ins]t+ or develop aft] n manufacture2 7,c7 9 p>agraph 7#c7-- 7i7 9 subp>agraph 7,a71 by /rik+ or #ebj7;f77#a7 & ins]t+ 1 #ebj7;f77#a71 or #ehg,v2 7ii7 9 subp>agraph 7,b71 by /rik+ & at ! end2 7iii7 9 subp>agraph 7,c71 by /rik+ ! p]iod & ins]t+ or #ehg,o2 &2 & 7iv7 by add+ at ! end ! foll[+3 7,d7 quality requirem5ts 7) respect to 9 vitro cl9ical te/s7 "u section #ehg,k4 2 & 7,d7 9 p>agraph 7#d7-- 7i7 9 subp>agraph 7,a71 by /rik+ 2 or & ins]t+ a semicolon2 7ii7 9 subp>agraph 7,b71 by /rik+ ! p]iod & ins]t+ 2 or2 & 7iii7 by add+ at ! end ! foll[+3 7,c7 ) respect to 9 vitro cl9ical te/s1 requirem5ts applicable to re/rict$ 9 vitro cl9ical te/s pursuant to section #ehg,o4 2 7#e7 9 subsection 7k71 by /rik+ or #ebj7;g7 & ins]t+ #ebj7;g71 or #ehg,s2 & 7#f7 9 subsection 7m7-- 7,a7 9 ! subsection head+1 by /rik+ ,laboratory te/s associat$ ) devices ins]t+ 9 vitro cl9ical te/s aft] devices2 & 7,b7 9 p>agraph 7#a7-- 7i7 by /rik+ to a device & ins]t+ to an 9 vitro cl9ical te/2 & 7ii7 by /rik+ su* device & ins]t+ su* 9 vitro cl9ical te/4 7b7 ,em]g5cy use ( m$ical products ,section #efd;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c;a7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#b71 by ins]t+ 9 vitro cl9ical te/1 aft] device12 & 7,b7 by add+ at ! end ! foll[+3 7#c7 ,develop] ,! t]m develop]1 ) respect to an 9 vitro cl9ical te/1 has ! mean+ giv5 su* t]m 9 section #ehg4 2 7#b7 by ins]t+ or develop] aft] manufactur] ea* place x appe>s2 & 7#c7 9 subsection 7c77#a7-- 7,a7 by ins]t+ or quality requirem5ts aft] good manufactur+ practice requirem5ts2 & 7,b7 by /rik+ or #ebj7;f77#a7 & ins]t+ 1 #ebj7;f77#a71 or #ehg,k4 7c7 ,products held = em]g5cy use ,section #efd;,b7#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c;b7#b77 is am5d$-- 7#a7 9 subp>agraph 7,a71 by /rik+ or #eae & ins]t+ #eae1 or #ehg;,b2 & 7#b7 9 subp>agraph 7,b71 by /rik+ or #ebj & ins]t+ #ebj1 or #ehg,s4 #g4 ,antimicrobial susceptibility te/s ,section #eaa;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;a-#b7 is am5d$-- 7#a7 9 subsection 7a77#a77;,c7-- 7,a7 by /rik+ cle> "u section #eaj7k71 classify "u section #eac7;f77#b71 or approve "u section #eae & ins]t+ approve "u section #ehg;,b1 exempt f prem>ket review "u section #ehg;,c1 or grant a te*nology c]tification ord] "u section #ehg;,d2 & 7,b7 by /rik+ te/+ devices & ins]t+ 9 vitro cl9ical te/s2 7#b7 9 subsection 7c77#e7-- 7,a7 by /rik+ drug or device & ins]t+ drug1 device1 or 9 vitro cl9ical te/2 & 7,b7 by /rik+ ! drug or ! device & ins]t+ ! drug1 device1 or 9 vitro cl9ical te/2 7#c7 9 subsection 7e7-- 7,a7 9 ! head+1 by /rik+ te/+ devices & ins]t+ ,9 vitro cl9ical te/s2 7,b7 9 p>agraph 7#a7-- 7i7 by /rik+ #eaj1 #eac1 & #eae1 & ins]t+ #ehg;,b1 & #ehg;,d2 7ii7 by /rik+ antimicrobial susceptibility te/+ device & ins]t+ antimicrobial susceptibility 9 vitro cl9ical te/2 & 7iii7 by /rik+ su* device & ins]t+ su* 9 vitro cl9ical te/2 & 7,c7 9 p>agraph 7#b7-- 7i7 9 ! head+1 by /rik+ te/+ devices & ins]t+ 9 vitro cl9ical te/s2 7ii7 9 subp>agraphs 7,a7 & 7,b7 7o!r ?an clause 7iii7 ( su* subp>agraph 7,b771 by /rik+ device ea* place x appe>s & ins]t+ 9 vitro cl9ical te/2 7iii7 9 subp>agraph 7,b77iii71 by /rik+ a device & ins]t+ an 9 vitro cl9ical te/2 & 7iv7 by am5d+ subp>agraph 7,c7 to read z foll[s3 7,c7 ,! antimicrobial susceptibility 9 vitro cl9ical te/ meets all o!r requirem5ts to be approv$ "u section #ehg;,b1 to be exempt$ f prem>ket review "u section #ehg;,c1 or to be (f]$ "u a te*nology c]tification ord] "u section #ehg;,d4 2 7#d7 9 subsection 7f71 by am5d+ p>agraph 7#a7 to read z foll[s3 7#a7 ,! t]m antimicrobial susceptibility 9 vitro cl9ical te/ means an 9 vitro cl9ical te/ t utilizes susceptibility te/ int]pretive crit]ia to det]m9e & report ! 9 vitro susceptibility ( c]ta9 microorganisms to a drug 7or drugs74 2 & 7#e7 9 subsection 7g77#b7-- 7,a7 by am5d+ ! matt] prec$+ subp>agraph 7,a7 to read z foll[s3 7#b7 ) respect to approv+ an application "u section #ehg;,b or grant+ a te*nology c]tification ord] "u section #ehg;,d-- 2 & 7,b7 9 subp>agraph 7,a7-- 7i7 by /rik+ device & ins]t+ 9 vitro cl9ical te/2 & 7ii7 by /rik+ antimicrobial susceptibility te/+ device & ins]t+ antimicrobial susceptibility 9 vitro cl9ical te/4 #h4 ,comb9ation products 7a7 ,9 g5]al ,section #ejc7;g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;g77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9 subp>agraph 7,a71 by /rik+ or biological product & ins]t+ 9 vitro cl9ical te/ 7except = a product con/itut$ ( a device & an 9 vitro cl9ical te/71 or biological product2 7,b7 9 subp>agraph 7,b71 by add+ at ! end ! foll[+3 ,= purposes ( ?is ,act1 a product t con/itutes a comb9ation ( a device & an 9 vitro cl9ical te/ is n a comb9ation product )9 ! mean+ ( ?is subsection & an 9 vitro cl9ical te/ t is (f]$ z a sep>ate product int5d$ to in=m ! use ( a drug1 biological product1 or device is n a comb9ation product )9 ! mean+ ( ?is subsection42 & 7,c7 9 subp>agraph 7,d77ii7-- 7i7 by ins]t+ or 9 vitro cl9ical te/ aft] device2 & 7ii7 by ins]t+ & 9 vitro cl9ical te/s be=e %all2 7#b7 9 p>agraph 7#c71 by /rik+ safety & effectiv5ess or sub/antial equival5ce & ins]t+ safety & effectiv5ess1 sub/antial equival5ce1 or analytical validity & cl9ical validity be=e = ! approv$ con/itu5t "p2 7#c7 9 p>agraph 7#d7-- 7,a7 9 subp>agraph 7,a71 by /rik+ or #eac7;f77#b7 7submitt$ 9 accordance ) p>agraph 7#e77 & ins]t+ #eac7;f77#b7 7submitt$ 9 accordance ) p>agraph 7#e771 #ehg;,b1 or #ehg;,d2 & 7,b7 9 subp>agraph 7,c71 by /rik+ or #eae & ins]t+ #eae1 or #ehg;,b1 or t is "u an ord] "u section #ehg;,d2 7#d7 9 p>agraph 7#e77;,a71 by /rik+ or #eaj7k7 & ins]t+ 1 #eaj7k71 #ehg;,b1 or #ehg;,d2 7#e7 9 p>agraph 7#g71 by /rik+ or sub/antial equival5ce & ins]t+ 1 sub/antial equival5ce1 or analytical validity & cl9ical validity2 7#f7 9 p>agraph 7#h71 by add+ at ! end ! foll[+3 7,i7 ,?is p>agraph %all n apply to a product con/itut$ ( a device & an 9 vitro cl9ical te/4 2 & 7#g7 9 p>agraph 7#i7-- 7,a7 9 subp>agraph 7,c77i71 by /rik+ or #ebj7;g7 & ins]t+ #ebj7;g71 #ehg;,b1 or #ehg;,d2 & 7,b7 9 subp>agraph 7,d71 by /rik+ or #ebj & ins]t+ #ebj1 #ehg;,b1 or #ehg;,d4 7b7 ,classification ( products ,section #efc ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#b7 is am5d$ by add+ at ! end ! foll[+3 7d7 ,exemption ,?is section %all n apply to a product con/itut$ ( only a device & an 9 vitro cl9ical te/4 4 #i4 ,res\rces 7a7 ,f9d+s ,congress f9ds t ! fees au?oriz$ by ?is section w be d$icat$ to meet+ ! goals id5tifi$ 9 ! lett]s f ! ,secret>y ( ,heal? & ,human ,s]vices to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 z set =? 9 ! ,congressional ,record4 7b7 ,e/abli%m5t ( us] fee program 7#a7 ,developm5t ( us] fees = 9 vitro cl9ical te/s 7,a7 ,9 g5]al ,beg9n+ n lat] ?an ,octob] #a1 #bjbe1 ! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is section ref]r$ to z ! ,secret>y7 %all initiate ! developm5t ( recomm5dations 9 accordance ) ?is section to pres5t to ,congress ) respect to ! goals1 & plans = meet+ ! goals1 = ! process = ! review ( 9 vitro cl9ical te/ submissions & applications "u sub*apt] ,j ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by ?is ,act1 = ! fir/ #d fiscal ye>s aft] fiscal ye> #bjbh & = ! au?orization ( ! ,9 ,vitro ,cl9ical ,te/ ,us] ,fee ,program = su* fiscal ye>s4 ,9 develop+ su* recomm5dations1 ! ,secret>y %all consult )-- 7i7 ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate2 7ii7 ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives2 7iii7 sci5tific & academic exp]ts2 7iv7 heal? c>e pr(essionals2 7v7 repres5tatives ( pati5t & consum] advocacy gr\ps2 & 7vi7 ! regulat$ indu/ry4 7,b7 ,prior public input ,prior to beg9n+ negotiations ) ! regulat$ indu/ry on ! au?orization ( ! ,9 ,vitro ,cl9ical ,te/ ,us] ,fee ,program1 z describ$ 9 ?is section1 ! ,secret>y %all-- 7i7 publi% a notice 9 ! ,f$]al ,regi/] reque/+ public input on ! au?orization ( us] fees2 7ii7 hold a public meet+ at :i* ! public may pres5t its views on ! au?orization1 includ+ specific sugge/ions = ! recomm5dations submitt$ "u subp>agraph 7,e72 7iii7 provide a p]iod ( #cj days aft] ! public meet+ to obta9 writt5 comm5ts f ! public sugge/+ *anges to ! ,9 ,vitro ,cl9ical ,te/ ,us] ,fee ,program2 & 7iv7 publi% any comm5ts receiv$ "u clause 7iii7 on ! website ( ! ,food & ,drug ,adm9i/ration4 7,c7 ,p]iodic consultation ,n less frequ5tly ?an once e mon? dur+ negotiations ) ! regulat$ indu/ry1 ! ,secret>y %all hold discussions ) repres5tatives ( pati5t & consum] advocacy gr\ps to cont9ue discussions ( ! au?orization ( ! ,9 ,vitro ,cl9ical ,te/ ,us] ,fee ,program & to solicit sugge/ions to be includ$ 9 ! recomm5dations transmitt$ to ,congress "u subp>agraph 7,f74 7,d7 ,updates to ,congress ,! ,secret>y1 9 consultation ) regulat$ indu/ry1 %all provide regul> updates on negotiations on ! reau?orization ( ! ,9 ,vitro ,cl9ical ,te/ ,us] ,fee ,program to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives4 7,e7 ,public review ( recomm5dations ,aft] negotiations ) ! regulat$ indu/ry1 ! ,secret>y %all-- 7i7 pres5t ! recomm5dations develop$ "u subp>agraph 7,a7 to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives2 7ii7 publi% su* recomm5dations 9 ! ,f$]al ,regi/]2 7iii7 provide = a p]iod ( #cj days = ! public to provide writt5 comm5ts on su* recomm5dations2 7iv7 hold a meet+ at :i* ! public may pres5t its views on su* recomm5dations2 & 7v7 aft] consid]ation ( su* public views & comm5ts1 revise su* recomm5dations z necess>y4 7,f7 ,transmittal ( recomm5dations 7i7 ,9 g5]al ,n lat] ?an ,janu>y #ae1 #bjbg1 ! ,secret>y %all transmit to ,congress ! revis$ recomm5dations "u subp>agraph 7,a71 a summ>y ( ! views & comm5ts receiv$ "u su* subp>agraph1 & any *anges made to ! recomm5dations 9 response to su* views & comm5ts4 7ii7 ,recomm5dation requirem5ts ,! recomm5dations transmitt$ "u ?is subp>agraph %all-- 7,i7 include ! numb] ( full-"t equival5t employees p] fiscal ye> t are agre$ to be hir$ to c>ry out ! goals includ$ 9 su* recomm5dations = ea* ye> ( ! #e-ye> p]iod2 7,,ii7 provide t ! am\nt ( op]at+ res]ve balance 9 ! us] fee program e/abli%$ "u ?is section is n m ?an ! equival5t ( #aj weeks ( op]at+ res]ve2 7,,iii7 require ! developm5t ( a /rategic plan = any surplus )9 ! op]at+ res]ve acc\nt above ! #aj-week op]at+ res]ve )9 #b ye>s ( ! e/abli%m5t ( ! program2 7,,iv7 include an op]at+ res]ve adju/m5t su* t1 if ! ,secret>y has an op]at+ res]ve balance 9 excess ( #aj weeks ( su* op]at+ res]ves1 ! ,secret>y %all decrease su* fee rev5ue & fees to provide = n m ?an #aj weeks ( su* op]at+ res]ves2 7,v7 if an adju/m5t is made z describ$ 9 subclause 7,,iv71 provide ! rationale = ! am\nt ( ! decrease 9 fee rev5ue & fees %all be conta9$ 9 ! ,f$]al ,regi/]2 & 7,,vi7 provide t ! fees assess$ & collect$ = ! full-"t equival5t employees at ! ,c5t] = ,devices & ,radiological ,heal?1 ) respect to :i* ! majority ( "t report+ data indicates are d$icat$ to ! process = ! review ( 9 vitro cl9ical te/ submissions & applications "u p>agraph 7#e71 are n support$ by ! funds au?oriz$ to be collect$ & assess$ "u section #gch ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j74 7,g7 ,publication ( recomm5dations ,! ,secret>y %all publi% on ! website ( ! ,food & ,drug ,adm9i/ration ! revis$ recomm5dations "u subp>agraph 7,f71 a summ>y ( ! recomm5dations1 views1 & comm5ts receiv$ "u subp>agraphs 7,b71 7,c71 & 7,e71 & any *anges made to ! recomm5dations orig9ally propos$ by ! ,secret>y 9 response to su* recomm5dations1 views1 & comm5ts4 7,h7 ,m9utes ( negotiation meet+s 7i7 ,public availability ,! ,secret>y %all make publicly available1 on ! website ( ! ,food & ,drug ,adm9i/ration1 m9utes ( all negotiation meet+s conduct$ "u ?is subsection betwe5 ! ,food & ,drug ,adm9i/ration & ! regulat$ indu/ry n lat] ?an #cj days aft] su* meet+4 7ii7 ,cont5t ,! m9utes describ$ "u clause 7i7 %all summ>ize any sub/antive proposal made by any p>ty to ! negotiations1 any significant controv]sies or diff]5ces ( op9ion dur+ ! negotiations1 & ! resolution ( any su* controv]sy or diff]5ce ( op9ion4 7#b7 ,e/abli%m5t ( us] fee program ,effective on ,octob] #a1 #bjbh1 provid$ t ! ,secret>y transmits ! recomm5dations "u p>agraph 7#a77;,f71 ! ,secret>y is au?oriz$ to collect us] fees relat+ to ! review ( 9 vitro cl9ical te/ submissions & applications submitt$ "u sub*apt] ,j ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by ?is ,act1 & any o!r activities or goals includ$ 9 recomm5dations transmitt$ to ,congress pursuant to ?is subsection4 ,fees "u su* program %all be assess$ & collect$ only if ! requirem5ts "u p>agraph 7#d7 are met4 7#c7 ,audit 7,a7 ,9 g5]al ,beg9n+ #b ye>s aft] fir/ receiv+ a us] fee applicable to submission ( an 9 vitro cl9ical te/ application submitt$ "u sub*apt] ,j ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by ?is ,act1 ! ,secret>y %all1 on a bi5nial basis1 p]=m an audit ( ! co/s ( review+ su* applications & any o!r activities "u su* sub*apt] ,j includ$ 9 recomm5dations transmitt$ to ,congress pursuant to ?is subsection4 ,su* an audit %all comp>e ! co/s ( review+ su* applications & o!r activities "u su* sub*apt] ,j to ! am\nt ( ! us] fee applicable to su* applications & make any necess>y adju/m5ts z describ$ 9 subp>agraph 7,b74 7,b7 ,alt]ation ( us] fee ,! foll[+ adju/m5ts %all apply ) respect to audits p]=m$ "u subp>agraph 7,a73 7i7 ,if ! audit p]=m$ #b ye>s aft] fir/ receiv+ a us] fee applicable to submission ( an 9 vitro cl9ical te/ application describ$ "u subp>agraph 7,a7 indicates t ! us] fees collect$ = purposes ( su* sub*apt] ,j exce$ #cc p]c5t ( ! co/s ( review+ su* applications & c>ry+ out activities includ$ 9 recomm5dations transmitt$ to ,congress pursuant to ?is subsection1 ! ,secret>y %all alt] ! us] fees applicable to applications submitt$ "u su* sub*apt] ,j su* t ! us] fees d n exce$ su* p]c5tage4 7ii7 ,if ! audit p]=m$ #f ye>s aft] fir/ receiv+ a us] fee applicable to submission ( an 9 vitro cl9ical te/ application describ$ "u subp>agraph 7,a7 indicates t ! us] fees collect$ = purposes ( su* sub*apt] ,j exce$ #dj p]c5t ( ! co/s ( review+ su* applications1 & c>ry+ out activities includ$ 9 recomm5dations transmitt$ to ,congress pursuant to ?is subsection1 ! ,secret>y %all alt] ! us] fees applicable to applications submitt$ "u su* sub*apt] ,j su* t ! us] fees d n exce$ su* p]c5tage4 7iii7 ,if ! audit p]=m$ #ab ye>s aft] fir/ receiv+ a us] fee applicable to submission ( an 9 vitro cl9ical te/ application describ$ "u subp>agraph 7,a71 & any audit p]=m$ aft] su* date1 indicates t ! us] fees collect$ = purposes ( su* sub*apt] ,j exce$ #di p]c5t ( ! co/s ( review+ su* applications1 & c>ry+ out activities includ$ 9 recomm5dations transmitt$ to ,congress pursuant to ?is subsection1 ! ,secret>y %all alt] ! us] fees applicable to applications submitt$ "u su* sub*apt] ,j su* t ! us] fees d n exce$ su* p]c5tage4 7,c7 ,acc\nt+ /&>ds ,! ,secret>y %all p]=m an audit "u subp>agraph 7,a7 9 con=mance ) ! acc\nt+ pr9ciples1 /&>ds1 & requirem5ts prescrib$ by ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates "u section #ceaa ( title #ca1 ,unit$ ,/ates ,code1 to ensure ! validity ( any pot5tial v>iability4 7,d7 ,implem5tation requirem5ts ,9 ! ev5t t ! ,secret>y fails to promulgate ! regulations describ$ 9 section #ehg;,b7a77#d71 #ehg;,d7j71 or #ehg,s7b77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #c1 by ! applicable deadl9e = ea* su* regulations z describ$ 9 section #e7;a77#b77;,a77ii71 ! ,secret>y %all provide t ! us] fees applicable to applications submitt$ "u sub*apt] ,j ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #c1 d n exce$ #cj p]c5t ( ! co/s ( review+ su* applications4 7#d7 ,conditions ,! us] fee program describ$ 9 ?is subsection %all take effect only if ! ,food & ,drug ,adm9i/ration issues a regulation relat$ to ! review requirem5ts = 9 vitro diagno/ic te/s t w\ld be subject to prem>ket review "u section #ehg;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #c1 ! review requirem5ts = te/ categories eligible = te*nology c]tification "u section #ehg;,d ( su* ,act1 z add$ by section #c1 & ! p>amet]s = ! te/ categories t w\ld be exempt f any review "u sub*apt] ,j ( *apt] ,v ( su* ,act4 7#e7 ,us] fee program def9itions & res\rce requirem5ts 7,a7 ,9 g5]al ,! t]m process = ! review ( 9 vitro cl9ical te/ submissions & applications means ! foll[+ activities ( ! ,secret>y ) respect to ! review ( 9 vitro cl9ical te/ prem>ket & te*nology c]tification applications includ+ supplem5ts = su* applications3 7i7 ,! activities necess>y = ! review ( prem>ket applications1 prem>ket reports1 te*nology c]tification applications1 & supplem5ts to su* applications4 7ii7 ,actions relat$ to submissions 9 connection ) 9 vitro cl9ical te/ developm5t1 ! issuance ( action lett]s t all[ ! m>ket+ ( 9 vitro cl9ical te/s or :i* set =? 9 detail ! specific defici5cies 9 su* applications1 reports1 supplem5ts1 or submissions &1 :]e appropriate1 ! actions necess>y to support ! developm5t ( 9 vitro cl9ical te/s4 7iii7 ,! inspection ( manufactur+ e/abli%m5ts & o!r facilities und]tak5 z "p ( ! ,secret>y's review ( p5d+ prem>ket applications1 te*nology c]tifications1 & supplem5ts4 7iv7 ,monitor+ ( rese>* conduct$ 9 connection ) ! review ( su* applications1 supplem5ts1 & submissions4 7v7 ,review ( 9 vitro cl9ical te/ applications subject to section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 & activities conduct$ 9 anticipation ( ! submission ( su* applications = inve/igational use "u section #ehg,s ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z add$ by section #c74 7vi7 ,! developm5t ( guidance1 policy docum5ts1 or regulations to improve ! process = ! review ( prem>ket applications1 te*nology c]tification applications1 & supplem5ts4 7vii7 ,! developm5t ( volunt>y te/ me?ods1 cons5sus /&>ds1 or m&atory p]=mance /&>ds 9 connection ) ! review ( su* applications1 supplem5ts1 or submissions & relat$ activities4 7viii7 ,! provision ( te*nical assi/ance to 9 vitro cl9ical te/ develop]s 9 connection ) ! submission ( su* applications1 reports1 supplem5ts1 or submissions4 7ix7 ,any activity und]tak5 9 connection ) ! initial classification or reclassification ( an 9 vitro cl9ical te/ 9 connection ) any requirem5t = approval or eligibility = an exemption f prem>ket review ( an 9 vitro cl9ical te/4 7x7 ,any activity und]tak5 9 connection ) mak+ a pa?way det]m9ation ( an 9 vitro cl9ical te/1 includ+ ! id5tification1 e/abli%m5t1 & implem5tation ( mitigation measures4 7xi7 ,evaluation ( po/m>ket /udies requir$ z a condition ( an approval ( a prem>ket application ( an 9 vitro cl9ical te/ & ensur+ su* /udies are conduct$ z requir$4 7xii7 ,any activity und]tak5 9 connection ) ensur+ 9 vitro cl9ical te/s (f]$ "u an exemption f prem>ket review pursuant to section #ehg;,c or #ehg;,g meet ! crit]ia = su* exemption & ! applicable /&>d4 7xiii7 ,compil+1 develop+1 & review+ in=mation on 9 vitro cl9ical te/s necess>y to id5tify issues ) ! ability ( 9 vitro cl9ical te/s to meet ! applicable /&>d1 z applicable4 7,b7 ,res\rce requirem5ts ,fees collect$ & assess$ "u ?is section %all be us$ = ! process = ! review ( 9 vitro cl9ical te/ applications1 z describ$ 9 subp>agraph 7,a71 & %all-- 7i7 be subject to ! limitation "u section #gch7;g77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7g77#c771 9 ! same mann] t fees collect$ & assess$ "u section #gcg7i77;,c7 ( su* ,act 7#ba ,u4,s4,c4 #cgi;i7#i77;,c77 are subject to su* limitation2 7ii7 include travel exp5ses = (fic]s & employees ( ! ,food & ,drug ,adm9i/ration only if ! ,secret>y det]m9es t su* travel is directly relat$ to an activity describ$ 9 subp>agraph 7,a72 & 7iii7 n be allocat$ to purposes describ$ "u section #gbb7;a7 ( ! ,consolidat$ ,appropriations ,act1 #bjah 7,public ,law #aae-ada74 7c7 ,reports 7#a7 ,p]=mance report 7,a7 ,9 g5]al 7i7 ,g5]al requirem5ts ,beg9n+ ) fiscal ye> #bjbh1 = ea* fiscal ye> = :i* fees are collect$ "u ?is section1 ! ,secret>y %all prep>e & submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives annual reports conc]n+ ! progress ( ! ,food & ,drug ,adm9i/ration 9 a*iev+ ! goals id5tifi$ 9 ! recomm5dations transmitt$ to ,congress by ! ,secret>y pursuant to subsection 7b77#a77;,f7 dur+ su* fiscal ye> & ! future plans ( ! ,food & ,drug ,adm9i/ration = meet+ ! goals4 7ii7 ,additional in=mation ,beg9n+ ) fiscal ye> #bjbh1 ! annual report "u ?is subp>agraph %all include ! progress ( ! ,food & ,drug ,adm9i/ration 9 a*iev+ ! goals1 & future plans = meet+ ! goals1 includ+-- 7,i7 ! numb] ( prem>ket applications fil$ "u section #ehg;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act dur+ ! applicable fiscal ye>2 7,,ii7 ! numb] ( te*nology c]tification applications submitt$ "u section #ehg;,d ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act dur+ ! applicable fiscal ye> = ea* review division2 7,,iii7 ! numb] ( break?r\gh designations "u section #ehg;,i ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act dur+ ! applicable fiscal ye>2 & 7,,iv7 ! numb] ( in=mation reque/s reque/$ by ! ,secret>y pursuant to section #ehg;,g7d7 ( su* ,act4 7iii7 ,real-"t report+ 7,i7 ,9 g5]al ,n lat] ?an #cj cal5d> days aft] ! end ( ! second qu>t] ( fiscal ye> #bjbh1 & n lat] ?an #cj cal5d> days aft] ! end ( ea* qu>t] ( ea* fiscal ye> !reaft]1 ! ,secret>y %all po/ ! data describ$ 9 subclause 7,,ii7 on ! website ( ! ,food & ,drug ,adm9i/ration = su* qu>t] & on a cumulative basis = su* fiscal ye>1 & may remove duplicative data f ! annual report "u ?is subp>agraph4 7,,ii7 ,data ,! ,secret>y %all po/ ! foll[+ data 9 accordance ) subclause 7,i73 7aa7 ,! numb] & titles ( draft & f9al regulations on topics relat$ to ! process = ! review ( 9 vitro cl9ical te/ submissions & applications1 & :e!r su* regulations 7 requir$ by /atute or pursuant to ! recomm5dations transmitt$ to ,congress by ! ,secret>y pursuant to subsection 7b77#a77;,f74 7bb7 ,! numb] & titles ( draft & f9al guidance on topics relat$ to ! process = ! review ( 9 vitro cl9ical te/ submissions & applications1 & :e!r su* guidances 7 issu$ z requir$ by /atute or pursuant to ! recomm5dations transmitt$ to ,congress by ! ,secret>y pursuant to subsection 7b77#a77;,f74 7cc7 ,! numb] & titles ( public meet+s held on topics relat$ to ! process = ! review ( 9 vitro cl9ical te/s1 & if su* meet+s 7 requir$ by /atute or pursuant to ! recomm5dations transmitt$ to ,congress by ! ,secret>y pursuant to subsection 7b77#a77;,f74 7iv7 ,rationale = ,,ivct us] fee program *anges ,beg9n+ ) fiscal ye> #bjbh1 ! ,secret>y %all include 9 ! annual p]=mance report "u p>agraph 7#a7-- 7,i7 data1 analysis1 & discussion ( ! *anges 9 ! numb] ( individuals hir$ z agre$ ^u 9 ! recomm5dations transmitt$ to ,congress by ! ,secret>y pursuant to subsection 7b77#a77;,f7 & ! numb] ( rema9+ vacancies1 ! numb] ( full-"t equival5ts fund$ by fees collect$ pursuant to ?is section1 & ! numb] ( full-"t equival5ts fund$ by budget au?ority at ! ,food & ,drug ,adm9i/ration by ea* division )9 ! ,c5t] = ,devices & ,radiological ,heal?1 ! ,c5t] = ,biologics ,evaluation & ,rese>*1 ! ,(fice ( ,regulatory ,affairs1 & ! ,(fice ( ! ,commission]2 7,,ii7 data1 analysis1 & discussion ( ! *anges 9 ! fee rev5ue am\nts & co/s = ! process = ! review ( 9 vitro cl9ical te/ submissions & applications1 includ+ id5tify+-- 7aa7 driv]s ( su* *anges2 & 7bb7 *anges 9 ! av]age total co/ p] full-"t equival5t 9 ! 9 vitro cl9ical te/ review program2 7,,iii7 = ea* ( ! ,c5t] = ,devices & ,radiological ,heal?1 ! ,c5t] = ,biologics ,evaluation & ,rese>*1 ! ,(fice ( ,regulatory ,affairs1 & ! ,(fice ( ! ,commission]1 ! numb] ( employees = :om "t report+ is requir$ & ! numb] ( employees = :om "t report+ is n requir$2 & 7,,iv7 data1 analysis1 & discussion ( ! *anges 9 ! av]age full-"t equival5t h\rs requir$ to complete review ( ea* type ( 9 vitro cl9ical te/ application4 7v7 ,analysis ,= ea* fiscal ye>1 ! ,secret>y %all include 9 ! report "u clause 7i7 an analysis ( ! foll[+3 7,i7 ,! diff]5ce betwe5 ! aggregate numb] ( prem>ket applications fil$ "u section #ehg;,b or section #ehg;,d ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act & ! aggregate numb] ( major defici5cy lett]s1 n approvable lett]s1 & d5ials = su* applications issu$ by ! ag5cy1 acc\nt+ =-- 7aa7 ! numb] ( applications fil$ "u ea* ( sections #ehg;,b & #ehg;,d ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act dur+ "o fiscal ye> = :i* a decision is n s*$ul$ to be made until ! foll[+ fiscal ye>2 & 7bb7 ! aggregate numb] ( applications "u ea* ( sections #ehg;,b & #ehg;,d ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act = ea* fiscal ye> t did n meet ! goals z id5tifi$ by ! recomm5dations transmitt$ to ,congress by ! ,secret>y pursuant to subsection 7b77#a77;,f74 7,,ii7 ,relevant data to det]m9e :e!r ! ,c5t] = ,devices & ,radiological ,heal? has met p]=mance enhancem5t goals id5tifi$ by ! recomm5dations transmitt$ to ,congress by ! ,secret>y pursuant to subsection 7b77#a77;,f74 7,,iii7 ,! mo/ common causes & tr5ds = ext]nal or o!r circum/ances affect+ ! ability ( ! ,food & ,drug ,adm9i/ration to meet review "t & p]=mance enhancem5t goals id5tifi$ by ! recomm5dations transmitt$ to ,congress by ! ,secret>y pursuant to subsection 7b77#a77;,f74 7,b7 ,publication ,) reg>d to in=mation to be report$ by ! ,food & ,drug ,adm9i/ration to indu/ry on a qu>t]ly & annual basis pursuant to recomm5dations transmitt$ to ,congress by ! ,secret>y pursuant to subsection 7b77#a77;,f71 ! ,secret>y %all make su* in=mation publicly available on ! website ( ! ,food & ,drug ,adm9i/ration n lat] ?an #fj days aft] ! end ( ea* qu>t] or #abj days aft] ! end ( ea* fiscal ye>1 respectively1 to :i* su* in=mation applies4 7,c7 ,updates ,! ,secret>y %all include 9 ea* report "u subp>agraph 7,a7 in=mation on all previ\s cohorts = :i* ! ,secret>y has n giv5 a complete response on all 9 vitro cl9ical te/ prem>ket applications & te*nology c]tification ord]s & supplem5ts1 prem>ket1 & te*nology c]tification notifications 9 ! cohort4 7#b7 ,corrective action report ,beg9n+ ) fiscal ye> #bjbi1 = ea* fiscal ye> = :i* fees are collect$ "u ?is section1 ! ,secret>y %all prep>e & submit a corrective action report to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ! ,committee on ,appropriations ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce & ! ,committee on ,appropriations ( ! ,h\se ( ,repres5tatives4 ,! report %all include ! foll[+ in=mation1 z applicable3 7,a7 ,goals met ,= ea* fiscal ye>1 if ! ,secret>y det]m9es1 bas$ on ! analysis "u p>agraph 7#a77;,a77v71 t ea* ( ! goals id5tifi$ by ! recomm5dations transmitt$ to ,congress by ! ,secret>y pursuant to subsection 7b77#a77;,f7 = ! applicable fiscal ye> h be5 met1 ! corrective action report %all include recomm5dations on ways 9 :i* ! ,secret>y c improve & /reaml9e ! 9 vitro cl9ical te/ prem>ket application & te*nology c]tification review process4 7,b7 ,goals miss$ ,= ea* ( ! goals id5tifi$ by ! lett]s describ$ 9 recomm5dations transmitt$ to ,congress by ! ,secret>y pursuant to subsection 7b77#a77;,f7 = ! applicable fiscal ye> t ! ,secret>y det]m9es to n h be5 met1 ! corrective action report %all include-- 7i7 a ju/ification = su* det]m9ation2 7ii7 a description ( ! types ( circum/ances1 9 ! aggregate1 "u :i* applications or reports submitt$ "u sections #ehg;,b & #ehg;,d ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act miss$ ! review goal times b 7 approv$ dur+ ! fir/ cycle review1 z applicable2 7iii7 a summ>y & any tr5ds ) reg>d to ! circum/ances = :i* a review goal 0 miss$2 & 7iv7 ! p]=mance enhancem5t goals t 7 n a*iev$ dur+ ! previ\s fiscal ye> & a description ( ef=ts ! ,food & ,drug ,adm9i/ration has put 9 place = ! fiscal ye> 9 :i* ! report is submitt$ to improve ! ability ( su* ag5cy to meet ea* su* goal = ! su* fiscal ye>4 7#c7 ,fiscal report 7,a7 ,9 g5]al ,= fiscal ye>s #bjbi & annually !reaft]1 n lat] ?an #abj days aft] ! end ( ea* fiscal ye> dur+ :i* fees are collect$ "u ?is section1 ! ,secret>y %all prep>e & submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 a report on ! implem5tation ( ! au?ority = su* fees dur+ su* fiscal ye> & ! use1 by ! ,food & ,drug ,adm9i/ration1 ( ! fees collect$ dur+ su* fiscal ye> = :i* ! report is made4 7,b7 ,cont5ts ,su* report %all include exp5ditures del9eat$ by budget au?ority & us] fee doll>s relat$ to adm9i/rative exp5ses & in=mation te*nology infra/ructure contracts & exp5ditures4 7,c7 ,op]at+ res]ve ,su* report %all provide ! am\nt ( op]at+ res]ves ( c>ryov] us] fees available ea* ye>1 & any plann$ allocations or obligations ( su* balance ( op]at+ res]ves = ! program4 7#d7 ,public availability ,! ,secret>y %all make ! reports requir$ "u p>agraphs 7#a7 ?r\gh 7#c7 available to ! public on ! website ( ! ,food & ,drug ,adm9i/ration4 7#e7 ,enhanc$ communication 7,a7 ,communications ) ,congress ,ea* fiscal ye>1 z applicable & reque/$1 repres5tatives f ! ,c5t]s ) exp]tise 9 ! review ( 9 vitro cl9ical te/s %all meet ) repres5tatives f ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives to report on ! cont5ts describ$ 9 ! reports "u ?is section4 7,b7 ,p>ticipation 9 congressional he>+ ,ea* fiscal ye>1 z applicable & reque/$1 repres5tatives f ! ,food & ,drug ,adm9i/ration %all p>ticipate 9 a public he>+ be=e ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 to report on ! cont5ts describ$ 9 ! reports "u ?is section4 ,su* he>+ %all occur n lat] ?an #abj days aft] ! end ( ea* fiscal ye> = :i* fees are collect$ "u ?is section4 #aj4 ,au?orization ( appropriations ,= purposes ( fund+ implem5tation ( ?is ,act 7includ+ ! am5dm5ts made by ?is ,act71 includ+ und]tak+ activities = ! developm5t ( regulations & guidances1 hir+ ( necess>y /aff1 & ! developm5t ( te*nology sy/ems to implem5t ?is ,act 7includ+ ! am5dm5ts made by ?is ,act7 9 a timely1 effective1 & effici5t mann]1 !re is au?oriz$ to be appropriat$ #dhj1jjj1jjj1 to rema9 available ?r\gh ! end ( fiscal ye> #bjbh4 #aa4 ,guidance on ,diagno/ic ,innovation ,n lat] ?an ,janu>y #a1 #bjbe1 ! ,secret>y %all issue guidance to assi/ develop]s ( 9 vitro cl9ical te/s int5d$ to id5tify or diagnose r>e diseases & 9 vitro cl9ical te/s int5d$ to address an unmet m$ical ne$4 ,su* guidance %all include consid]ations = address+ b>ri]s to develop+ suffici5t data to demon/rate cl9ical validity = su* te/s1 su* z *all5ges associat$ ) data collection & ob/acles to ! timely g5]ation ( evid5ce4 #ab4 ,,gao report on unique consid]ations ,n lat] ?an #c ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report-- 7#a7 evaluat+ ! unique consid]ations = hospital-bas$ laboratories1 laboratories s]v+ academic m$ical c5t]s1 & o!r heal? c>e practition]s1 z appropriate1 9 implem5t+ ?is ,act1 includ+ ! am5dm5ts made by ?is ,act2 & 7#b7 includ+ recomm5dations bas$ on ! f9d+s ( ! report4 #ac4 ,assessm5ts ,section #ahcd;,a7g7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem-#a7;g77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#c7 ,det]m9ations ) respect to 9 vitro cl9ical te/s ,on or aft] ! date t is #de days aft] ! date ( enactm5t ( ! ,,valid ,act ( #bjbc1 = purposes ( det]m9+ :e!r an 9 vitro cl9ical te/ 7z def9$ 9 section #bja7ss7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act7 is reasonable & necess>y = ! diagnosis or treatm5t ( illness or injury 7"u section #ahfb7;a77#a77;,a771 any assessm5t ( ! analytical validity or cl9ical validity ( su* te/ %all apply ! def9itions giv5 su* t]ms 9 sub*apt] ,j ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act4 4 #ad4 ,sev]ability ,if any provision ( ?is ,act is decl>$ uncon/itutional1 or ! applicability ( ?is ,act to any p]son or circum/ance is held invalid1 ! con/itutionality ( ! rema9d] ( ?is ,act & ! applicability !re( to o!r p]sons & circum/ances %all n be affect$4