,,ii #aaf? ,,congress #b;d ,session ,s4 #cdjd ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,m>* #e1 #bjbj,mr4 ,burr 7= himself & ,mr4 ,b5net7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act to provide = ! regulation ( 9 vitro cl9ical te/s1 & = o!r purposes4 #a4 ,%ort title2 table ( cont5ts 7a7 ,%ort title ,?is ,act may be cit$ z ! ,v]ify+ ,accurate ,lead+-edge ,,ivct ,developm5t ,act ( #bjbj or ! ,,valid ,act ( #bjbj4 7b7 ,table ( cont5ts ,! table ( cont5ts ( ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4 ,sec4 #b4 ,def9itions4 ,sec4 #c4 ,regulation ( 9 vitro cl9ical te/s4 ,,sub*apt] ,j--,9 ,vitro ,cl9ical ,te/s ,,sub*apt] ,j4 ,9 ,vitro ,cl9ical ,tests,sec4 #ehg4 ,def9itions4 ,sec4 #ehg;,a4 ,applicability4 ,sec4 #ehg;,b4 ,prem>ket review4 ,sec4 #ehg;,c4 ,break?r\gh 9 vitro cl9ical te/s4 ,sec4 #ehg;,d4 ,te*nology c]tification4 ,sec4 #ehg;,e4 ,mitigat+ measures4 ,sec4 #ehg;,f4 ,regulatory pa?way r$esignation4 ,sec4 #ehg;,g4 ,advisory committees4 ,sec4 #ehg;,h4 ,reque/ = in=mal fe$back4 ,sec4 #ehg;,i4 ,regi/ration & li/+4 ,sec4 #ehg;,j4 ,te/ design & quality requirem5ts4 ,sec4 #ehg,k4 ,label+ requirem5ts4 ,sec4 #ehg,l4 ,adv]se ev5t report+4 ,sec4 #ehg,m4 ,corrections & removals4 ,sec4 #ehg,n4 ,re/rict$ 9 vitro cl9ical te/s4 ,sec4 #ehg,o4 ,appeals4 ,sec4 #ehg,p4 ,accr$it$ p]sons4 ,sec4 #ehg,q4 ,recogniz$ /&>ds4 ,sec4 #ehg,r4 ,inve/igational use4 ,sec4 #ehg,s4 ,collaborative communities = 9 vitro cl9ical te/s4 ,sec4 #ehg,t4 ,compreh5sive te/ in=mation sy/em4 ,sec4 #ehg,u4 ,preemption4 ,sec4 #ehg,v4 ,adult]ation4 ,sec4 #ehg,w4 ,misbr&+4 ,sec4 #ehg,x4 ,po/m>ket surveillance4 ,sec4 #ehg,y4 ,electronic =mat = submissions4 ,sec4 #ehg,z4 ,po/m>ket rem$ies4 ,sec4 #d4 ,en=cem5t & o!r provisions4 ,sec4 #e4 ,transition4 ,sec4 #f4 ,em]g5cy use au?orization4 ,sec4 #g4 ,antimicrobial susceptibility te/s4 ,sec4 #h4 ,comb9ation products4 ,sec4 #i4 ,res\rces4 4 #b4 ,def9itions 7a7 ,9 g5]al ,section #bja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7 is am5d$-- 7#a7 by add+ at ! end ! foll[+3 7ss7 7#a7 ,! t]m 9 vitro cl9ical te/-- 7,a7 means a te/ int5d$ by its develop] 7z def9$ 9 section #ehg7 to be us$ 9 ! collection1 prep>ation1 analysis1 or 9 vitro cl9ical exam9ation ( specim5s tak5 or d]iv$ f ! human body = ! purpose (-- 7i7 id5tify+ or diagnos+ a disease or condition2 7ii7 provid+ in=mation = diagnos+1 scre5+1 measur+1 detect+1 pr$ict+1 prognos+1 analyz+1 or monitor+ a disease or condition1 includ+ by mak+ a det]m9ation ( an individual's /ate ( heal?2 or 7iii7 select+1 monitor+1 or in=m+ !rapy or treatm5t = a disease or condition2 & 7,b7 may include-- 7i7 a te/ protocol or laboratory te/ protocol2 7ii7 an in/rum5t 7z def9$ 9 section #ehg7aa772 7iii7 an article = tak+1 d]iv+1 hold+1 or transport+ specim5s f ! human body 7z def9$ 9 section #ehg7af772 7iv7 s(tw>e1 exclud+ s(tw>e t is exclud$ by section #ebj7o7 f ! def9ition ( a device "u section #bja7;h71 & exclud+ modifications t are exempt 9 accordance ) section #ehg;,a7l77#b77;,a72 & 7v7 subject to subp>agraph 7#b71 a compon5t or "p ( a te/1 a te/ protocol1 an in/rum5t1 an article1 or s(tw>e describ$ 9 any ( clauses 7,a7 ?r\gh 7,d7 ( su* subp>agraph1 :e!r alone or 9 comb9ation1 includ+ reag5ts1 calibrators1 & controls4 7#b7 ,not)/&+ subp>agraph 7#a77v71 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 equipm5t1 includ+ c]ta9 pre-analytical equipm5t1 z det]m9$ by ! ,secret>y4 7,d7 ,an article us$ solely = p]sonal protection dur+ ! adm9i/]+1 conduct+1 or o!rwise p]=m+ ( te/ activities4 2 7#b7 by add+ at ! end ( section #bja7;g7 ! foll[+3 7#c7 ,! t]m drug does n include an 9 vitro cl9ical te/4 2 & 7#c7 9 section #bja7;h71 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 7,a7 ,! t]m analytical validity means1 ) respect to an 9 vitro cl9ical te/1 ! ability ( ! 9 vitro cl9ical te/1 to-- 7i7 suffici5tly id5tify1 measure1 detect1 calculate1 or analyze "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/2 or 7ii7 z applicable1 assi/ 9 su* id5tification1 measurem5t1 detection1 calculation1 or analysis4 7,b7 ,= an article = tak+ or d]iv+ specim5s f ! human body describ$ 9 section #bja7ss77#a77;,b77iii71 ! t]m analytical validity means t su* article p]=ms z int5d$ & w support ! analytical validity ( an 9 vitro cl9ical te/ ) :i* x is us$4 7#b7 ,applicable /&>d ,! t]m applicable /&>d1 ) respect to an 9 vitro cl9ical te/1 means a reasonable assurance ( analytical & cl9ical validity1 except t su* t]m-- 7,a7 ) respect to te/ in/rum5ts1 means a reasonable assurance ( analytical validity2 & 7,b7 ) respect to articles = tak+ or d]iv+ specim5s f ! human body = purposes describ$ 9 clause 7i7 or 7ii7 ( section #bja7ss77#a77;,a7 means a reasonable assurance ( analytical validity &1 :]e applicable1 safety4 7#c7 ,cl9ical use ,! t]m cl9ical use means ! op]ation1 application1 or function+ ( an 9 vitro cl9ical te/ 9 connection ) human specim5s1 includ+ pati5t1 consum]1 & donor specim5s1 = ! purpose = :i* x is int5d$ z describ$ 9 section #bja7ss77#a77;,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#a77;,a74 7#e7 ,cross-ref]5c$ te/ ,! t]m cross-ref]5c$ te/ means an 9 vitro cl9ical te/ t ref]5ces 9 its label+ ! "n or int5d$ use ( ano!r m$ical product t is n an 9 vitro cl9ical te/4 7#f7 ,develop ,! t]m develop1 ) respect to an 9 vitro cl9ical te/1 means-- 7,a7 design+1 validat+1 produc+1 manufactur+1 remanufactur+1 propagat+1 or assembl+ an 9 vitro cl9ical te/2 7,b7 import+ an 9 vitro cl9ical te/2 7,c7 modify+ an 9 vitro cl9ical te/ initially develop$ by a diff]5t p]son 9 a mann] t-- 7i7 *anges any ( ! li/+ elem5ts t def9e indications = use specifi$ 9 p>agraph 7#aj71 p]=mance claims1 or1 z applicable1 ! safety ( su* 9 vitro cl9ical te/2 or 7ii7 affects ! analytical or cl9ical validity ( ! 9 vitro cl9ical te/ z int5d$ by ! develop]2 or 7,d7 adopt+1 us+1 or dissem9at+ = use z an 9 vitro cl9ical te/ an article n previ\sly int5d$ = cl9ical use4 7#g7 ,develop] ,! t]m develop] means a p]son :o engages 9 an activity describ$ 9 p>agraph 7#f7 = cl9ical use4 7#h7 ,fir/ ( a k9d ,! t]m fir/-(-a-k9d means1 ) respect to an 9 vitro cl9ical te/1 a te/ t has an int5d$ use & a comb9ation ( ! elem5ts specifi$ 9 p>agraph 7#aj7 t diff] f ! int5d$ use & su* elem5ts ( o!r 9 vitro cl9ical te/s t already are legally available 9 ! ,unit$ ,/ates4 7#i7 ,high-risk 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 ! 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/ or category-- 7i7 pres5ts pot5tial unreasonable risk = 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 pot5tially likely to result 9 ! abs5ce1 delay1 or discont9uation ( life-support+ or life-su/a9+ m$ical treatm5t4 7,b7 ,exception ,! t]m high-risk does n include an 9 vitro cl9ical te/ describ$ 9 subp>agraph 7,a7 if mitigat+ measures are e/abli%$ & appli$ to suffici5tly mitigate ! risk ( inaccurate results z describ$ 9 subp>agraph 7,a71 includ+-- 7i7 ! degree to :i* ! te*nology = ! int5d$ use ( ! 9 vitro cl9ical te/ is well-*>act]iz$1 & ! crit]ia = p]=mance ( ! te/ are well-e/abli%$ to be suffici5t = ! int5d$ use2 & 7ii7 ! cl9ical circum/ances "u :i* ! 9 vitro cl9ical te/ is us$1 & ! availability ( o!r te/s 7su* z confirmatory or adjunctive te/s7 or relevant mat]ial /&>ds4 7#aj7 ,indications = use ,! t]m indications = use means "o or m 9 vitro cl9ical te/s t h all ( ! foll[+ notification elem5ts 9 common3 7,a7 ,sub/ance or sub/ances measur$ 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#a77;,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 ,! t]m in/rum5t means an 9 vitro cl9ical te/ t is h>dw>e int5d$ by ! h>dw>e's develop] to be us$ ) "o or m 9 vitro cl9ical te/s to g5]ate a cl9ical te/ result1 includ+ 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 = :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/ics1 su* z tol]ance limits & signal range2 7,b7 h ! same int5d$ use or uses & function2 7,c7 %>e ! same measurem5t pr9ciples1 detection me?ods1 & reaction conditions2 & 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$ activities )9 or "u ! ov]sight ( a laboratory & n relat$ to ! design ( an 9 vitro cl9ical te/2 & 7,b7 includes-- 7i7 p]=m+ pre-analytical & po/-analytical processes = an 9 vitro cl9ical te/2 7ii7 conduct+ /&>d op]at+ proc$ures2 & 7iii7 prep>+ reag5ts or o!r te/ mat]ials t d n meet ! def9ition ( a 9 vitro cl9ical te/ = cl9ical use "u section #bja7ss74 7#ad7 ,l[-risk ,! t]m l[-risk1 ) respect to an 9 vitro cl9ical te/ or category ( 9 vitro cl9ical te/s1 means t-- 7,a7 an undetect$ inaccurate result f su* 9 vitro cl9ical te/1 or su* category ( 9 vitro cl9ical te/s1 :5 us$ z int5d$-- 7i7 w\ld cause m9imal or no h>m1 or m9imal or no disability1 or imm$iately rev]sible h>m1 or w\ld lead to only a remote risk ( adv]se pati5t impact or adv]se public heal? impact2 or 7ii7 c\ld cause non-life ?reat5+ injury1 h>m t is m$ically rev]sible1 or a delay 9 necess>y treatm5t2 or 7,b7 mitigat+ measures are suffici5t to ensure ! te/ meets ! requirem5ts ( subp>agraph 7,a7 7#ae7 ,mitigat+ measures ,! t]m mitigat+ measures-- 7,a7 means requirem5ts t ! ,secret>y det]m9es1 bas$ on available 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 inaccurate result or mis9t]pretation ( any result2 & 7,b7 includes1 z appropriate1 applicable requirem5ts reg>d+ label+1 p]=mance /&>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 & con=mance to /&>ds4 7#af7 ,specim5 receptacle ,! t]m specim5 receptacle means an 9 vitro cl9ical te/ specifically int5d$ = ! hold+1 /or+1 or transport+ ( specim5s d]iv$ f ! human body or = 9 vitro exam9ation = purposes describ$ 9 clause 7i7 or 7ii7 ( section #bja7ss77#a77;,a74 7#ag7 ,te*nology ,! t]m te*nology-- 7,a7 means a develop]'s gr\p+ ( 9 vitro cl9ical te/s t d n significantly diff] 9 control me*anisms1 en]gy s\rces1 or op]at+ pr9cipals & = :i* design1 developm5t1 & manufactur+1 includ+ analytical & cl9ical validation z applicable1 ( ! te/s w\ld be address$ 9 a simil> mann] or ?r\gh simil> proc$ures2 & 7,b7 may include clot detection1 colorimetric 7non-immunoassay71 electro*emical 7non-immunoassay71 enzymatic 7non-immunoassay71 fl[ cytometry1 fluorometry 7non-immunoassay71 immunoassay1 mass spectrometry or *romatography 7su* z ,,hplc71 microbial culture1 next g5]ation sequ5c+ 7also kn[n z ,,ngs71 nephlometric or turbidimetric 7non-immunoassay71 s+leplex or multiplex non-,,ngs nucleic acid analysis1 s+le-bas$ te*nology1 spectroscopy1 & any o!r te*nology1 z ! ,secret>y det]m9es appropriate4 7#ah7 ,te/ ,! t]m te/1 unless o!rwise provid$1 means an 9 vitro cl9ical te/4 7#ai7 ,valid sci5tific evid5ce ,! t]m valid sci5tific evid5ce-- 7,a7 means1 ) respect to an 9 vitro cl9ical te/1 evid5ce-- 7i7 t has be5 g5]at$ & 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$2 & 7ii7 f :i* x c be fairly & responsibly conclud$ by qualifi$ exp]ts :e!r ! applicable /&>d has be5 met by ! 9 vitro cl9ical te/ = its int5d$ use2 & 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 adequate = ! purpose ( mak+ a regulatory det]m9ation "u ! applicable /&>d 9 ! ,unit$ ,/ates4 7#bj7 ,well-*>act]iz$ ,! t]m well-*>act]iz$1 ) respect to an 9 vitro cl9ical te/1 means well-e/abli%$ & well-recogniz$ by ! sci5tific or cl9ical community1 if adequately evid5c$ by "o or m ( ! foll[+3 7,a7 ,pe]-review$ lit]ature4 7,b7 ,practice guidel9es4 7,c7 ,cons5sus /&>ds4 7,d7 ,recogniz$ /&>ds ( c>e4 7,e7 ,te*nology 9 use = _m ye>s4 7,f7 ,sci5tific publication by multiple sites4 7,g7 ,adoption by ! sci5tific or cl9ical community4 7,h7 ,real _w data4 #ehg;,a4 ,applicability 7a7 ,9 g5]al 7#a7 ,applicability ( ?is sub*apt] 7,a7 ,9 g5]al ,an 9 vitro cl9ical te/ %all be subject to ! requirem5ts ( ?is sub*apt]1 except z o!rwise provid$ ?is sub*apt]4 7,b7 ,int]/ate comm]ce ,any 9 vitro cl9ical te/ t is (f]$ = cl9ical use 9 ! ,unit$ ,/ates is deem$ to be introduc$ into int]/ate comm]ce = purposes ( en=c+ ! requirem5ts ( ?is ,act4 7,c7 ,non-applicable requirem5t ,subject to any exemption or exclusion 9 ?is section1 an 9 vitro cl9ical te/ %all n be subject to any provision or requirem5t ( ?is ,act o!r ?an ?is sub*apt] unless su* o!r provision or requirem5t-- 7i7 applies expressly to 9 vitro cl9ical te/s2 or 7ii7 describes ! au?ority ( ! ,secret>y :5 regulat+ su* 9 vitro cl9ical te/s or subset ( 9 vitro cl9ical te/s1 ) respect to-- 7,i7 all articles regulat$ by ! ,secret>y pursuant to ?is ,act2 or 7,,ii7 a subset ( su* articles t includes 9 vitro cl9ical te/s4 7#b7 ,laboratories & blood & tissue e/abli%m5ts 7,a7 ,relation to laboratory c]tification pursuant to section #cec ( ! ,,phsa ,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 t are duplicative ( regulations "u section #cec4 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 te/+1 label+1 packag+1 & /orage1 ( blood1 blood compon5ts1 human cells1 tissues1 or tissue products "u ?is ,act or section #cea or #cfa ( ! ,public ,heal? ,s]vice ,act4 7#c7 ,practice ( m$ic9e 7,a7 ,9 g5]al ,no?+ 9 ?is sub*apt] %all be con/ru$ to limit or int]f]e ) ! au?ority ( a heal? c>e practition] to prescribe or adm9i/] any legally m>ket$ 9 vitro cl9ical te/ = any condition or disease )9 a heal? c>e practition]-pati5t relation%ip pursuant to applicable ,f$]al or ,/ate law4 7,b7 ,rules ( con/ruction 7i7 ,sale1 di/ribution1 label+ ,no?+ 9 ?is p>agraph %all be con/ru$ 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 7ii7 ,promotion ( unapprov$ uses ,no?+ 9 ?is p>agraph %all be con/ru$ to alt] any prohibition on ! promotion ( unapprov$ uses ( legally m>ket$ 9 vitro cl9ical te/s4 7#d7 ,special rule 7,a7 ,prem>ket review applicable ,not)/&+ ! exemptions f prem>ket review "u section #ehg;,b set =? 9 subsections 7b71 7c71 7d71 7e71 7f71 7g71 7h71 7j71 & 7k7 an 9 vitro cl9ical te/ 7includ+ any article = tak+ or d]iv+ specim5s7 %all be subject to ! requirem5ts ( section #ehg;,b if ! ,secret>y det]m9es1 9 accordance ) subp>agraph 7,b71 t-- 7i7 7,i7 !re is insuffici5t valid sci5tific evid5ce to support ! analytical validity or ! cl9ical validity ( su* 9 vitro cl9ical te/2 & 7,,ii7 su* 9 vitro cl9ical te/ is be+ (f]$ by its develop] ) mat]ially deceptive or fraudul5t analytical or cl9ical claims2 7ii7 x is reasonably possible t su* 9 vitro cl9ical te/ w cause s]i\s adv]se heal? consequ5ces2 or 7iii7 9 ! case ( specim5 receptacles1 !re is suffici5t valid sci5tific evid5ce indicat+ t a specim5 receptacle did n p]=m z int5d$1 w n support ! analytical validity ( te/s ) :i* x is us$1 or z applicable1 is n safe = use4 7,b7 ,process 7i7 ,reque/ = in=mation ,if ! ,secret>y has valid sci5tific evid5ce indicat+ t ! crit]ia li/$ 9 subp>agraph 7,a7 apply to an 9 vitro cl9ical te/1 ! ,secret>y may reque/ t ! develop] ( ! te/ submit in=mation-- 7,i7 p]ta9+ to su* crit]ia2 & 7,,ii7 e/abli%+ ! basis = any claim$ exemption f prem>ket review4 7ii7 ,deadl9e = submitt+ in=mation ,^u receiv+ a reque/ = in=mation "u clause 7i71 ! develop] ( an 9 vitro cl9ical te/ %all submit ! in=mation )9 #cj days ( su* receipt4 7iii7 ,review deadl9e ,^u receiv+ a submission "u clause 7ii71 ! ,secret>y %all-- 7,i7 review ! submitt$ in=mation )9 #fj cal5d> days ( su* receipt2 & 7,,ii7 det]m9e :e!r ! crit]ia li/$ 9 subp>agraph 7,a7 apply to ! 9 vitro cl9ical te/4 7iv7 ,prem>ket review requir$ 7,i7 ,9 g5]al ,if ! ,secret>y f9ds t ! crit]ia li/$ 9 subp>agraph 7,a7 apply to ! 9 vitro cl9ical te/1 ! develop] %all-- 7aa7 promptly1 & n lat] ?an #ij days aft] ! date ( receipt ( su* in=mation1 submit an application = prem>ket review ( ! te/ "u section #ehg;,b2 or 7bb7 cease to m>ket ! te/4 7,,ii7 ,ext5sion ,! ,secret>y may grant an ext5sion to a develop] ( ! #ij-;day "t p]iod "u subclause 7,i77aa71 z appropriate4 7v7 ,cont9u$ m>ket+ ,dur+ ! p]iod beg9n+ on ! date ( a reque/ = in=mation "u clause 7ii7 & end+ on ! date ( ! disposition ( an application = prem>ket review ( ! 9 vitro cl9ical te/ "u section #ehg;,b1 ! develop] ( ! te/ may cont9ue to m>ket ! te/ = cl9ical use1 unless ! ,secret>y issues an ord] to ! develop] "u clause 7vi7 to imm$iately cease di/ribution ( ! te/4 7vi7 ,ord] to cease di/ribution 7,i7 ,9 g5]al ,if ! develop] ( an 9 vitro cl9ical te/ fails to submit an application = prem>ket review ( ! te/ by ! deadl9e applicable "u clause 7iv71 or ! ,secret>y f9ds t ! crit]ia li/$ 9 subp>agraph 7,a7 apply to an 9 vitro cl9ical te/ & t x is 9 ! be/ int]e/ ( ! public heal?1 ! ,secret>y may issue an ord]1 )9 #aj cal5d> days ( ! applicable deadl9e or f9d+ by ! ,secret>y1 requir+ ! develop] ( su* 9 vitro cl9ical te/1 & any o!r appropriate p]son 7includ+ a di/ributor or retail] ( ! 9 vitro cl9ical te/7 to imm$iately-- 7aa7 cease di/ribution ( ! te/ p5d+ approval ( an application = prem>ket review ( ! te/ "u section #ehg;,b2 & 7bb7 notify heal? pr(essionals & o!r us] facilities ( ! ord] to cease di/ribution & advise heal? c>e pr(essionals to cease use ( su* 9 vitro cl9ical te/4 7,,ii7 ,he>+ & review ,an ord] "u subclause 7,i7 %all provide ! p]son subject to ! ord] ) an opportunity = an in=mal he>+1 to be held n lat] ?an #aj days aft] ! date ( ! issuance ( ! ord]1 on ! actions requir$ 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 t]m9ate ! ord] )9 #cj days ( ! he>+4 ,^u t]m9at+ an ord]1 ! ,secret>y %all provide writt5 notice ( su* t]m9ation to ! develop]4 7vii7 ,am5dm5t to require recall ,if ! ,secret>y det]m9es t an ord] issu$ "u clause 7vi7 %\ld be am5d$ to include a recall ( ! 9 vitro cl9ical te/ ) respect to :i* ! ord] 0 issu$1 ! ,secret>y %all am5d ! ord] to require a recall4 ,9 su* am5d$ ord]1 ! ,secret>y %all specify a timetable 9 :i* ! 9 vitro cl9ical te/ recall w occur & %all require p]iodic reports to ! ,secret>y describ+ ! progress ( ! recall4 ,^u t]m9ation ( ! recall1 ! ,secret>y %all provide writt5 notice ( su* t]m9ation to ! develop]4 7viii7 ,effect ( te/ approval ,any ord] issu$ "u ?is p>agraph ) respect to an 9 vitro cl9ical te/ %all cease to be 9 effect if su* te/ is grant$ approval "u section #ehg;,b1 provid$ t ! 9 vitro cl9ical te/ is develop$ & (f]$ = cl9ical use 9 accordance ) su* approval4 7#e7 ,em]g5cy use 7,a7 ,9 g5]al ,9 ! case ( a public heal? em]g5cy "u section #cai ( ! ,public ,heal? ,s]vice ,act1 an 9 vitro cl9ical te/ is exempt f ! requirem5ts ( ?is sub*apt] & may be lawfully m>ket$ 9 accordance ) subp>agraph 7,b74 7,b7 ,crit]ia ,an 9 vitro cl9ical te/ may be lawfully m>ket$ 9 accordance ) ! exemption describ$ 9 subp>agraph 7,a7 if su* te/-- 7i7 is au?oriz$ = an em]g5cy use "u section #efd7;b72 or 7ii7 is develop$ & us$ 9 laboratories = :i* a c]tificate is 9 effect "u section #cec ( ! ,public ,heal? ,s]vice ,act to conduct high-complexity te/+ & ! develop]-- 7,i7 is pursu+ an em]g5cy use au?orization "u section #efd & provides updates to ! ,secret>y on ef=ts to pursue su* au?orization2 7,,ii7 validates su* 9 vitro cl9ical te/ prior to use2 7,,iii7 notifies ! ,secret>y ( ! assay validation2 & 7,,iv7 includes a /atem5t toge!r ) ! results ( ! te/ t reads3 ,?is ,,ivct 0 develop$ = use z a "p ( a response to a public heal? em]g5cy4 ,?is te/ has n be5 review$ by ! ,food & ,drug ,adm9i/ration44 7,c7 ,disposition ( product ,) respect to a previ\sly unapprov$ 9 vitro cl9ical te/ or an 9 vitro cl9ical te/s ) an unapprov$ use1 = :i* an em]g5cy use au?orization "u section #efd7;b7 ceases to be effective1 ! ,secret>y %all consult ) ! manufactur] ( su* product ) respect to ! appropriate disposition ( ! product4 7,d7 ,/reaml9+ ( application review ,a develop] may include any data or in=mation already submitt$ to ! ,secret>y )9 ! em]g5cy use au?orization z a "p ( a prem>ket application "u section #ehg;,b or a te*nology c]tification application "u section #ehg;,d4 7b7 ,compon5ts & ,p>ts 7#a7 ,exemption 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 a compon5t1 "p1 or raw mat]ial describ$ 9 section #bja7ss77#a77;,f7 is exempt f ! requirem5ts ( ?is sub*apt] if x is-- 7i7 int5d$ = fur!r developm5t z describ$ 9 p>agraph 7#b72 or 7ii7 is o!rwise to be 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)/&+ subp>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#b7 ,fur!r developm5t ,a compon5t1 "p1 or raw mat]ial 7z describ$ 9 p>agraph 7#a77;,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 ( ! ,v]ify+ ,accurate ,lead+-edge ,,ivct ,developm5t ,act ( #bjbj1 ! 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 7c7 ,gr&fa!r$ te/s 7#a7 ,exemption ,an 9 vitro cl9ical te/ t meets ! crit]ia set =? 9 p>agraph 7#b7 is exempt f ! requirem5ts ( ?is sub*apt]1 except z provid$ "u section #ehg;,a7a77#d71 ! regi/ration & li/+ requirem5ts "u section #ehg;,i1 & ! adv]se report+ requirem5ts "u section #ehg,l1 & may be lawfully m>ket$ subject to ! o!r applicable requirem5ts ( ?is ,act1 if-- 7,a7 ea* te/ report template = ! te/ be>s a /atem5t ( adequate prom95ce t reads z foll[s3 ,?is 9 vitro cl9ical te/ 0 develop$ & fir/ introduc$ prior to ! date ( enactm5t ( ! ,v]ify+ ,accurate ,lead+-edge ,,ivct ,developm5t ,act ( #bjbj & has n be5 review$ by ! ,food & ,drug ,adm9i/ration42 & 7,b7 ! develop] ( ! te/-- 7i7 ma9ta9s docum5tation demon/rat+ t ! te/ meets & cont9ues to meet ! crit]ia set =? 9 p>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 p>agraph 7#a7 if ! te/-- 7,a7 7i7 0 fir/ (f]$ = cl9ical use by su* laboratory be=e ! date ( enactm5t ( ! ,v]ify+ ,accurate ,lead+-edge ,,ivct ,developm5t ,act ( #bjbj2 7ii7 0 develop$ by a 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 & 7iii7 is p]=m$-- 7,i7 9 ! same cl9ical laboratory 9 :i* x 0 develop$2 7,,ii7 by ano!r cl9ical laboratory = :i* a c]tificate is 9 effect "u section #cec )9 ! same corporate organization & hav+ common own]%ip by ! same p>5t corporation2 or 7,,iii7 by a laboratory )9 a public heal? laboratory network coord9at$ or manag$ by ! ,c5t]s = ,disease ,control & ,prev5tion2 7,b7 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 approval "u section #ebj7m72 & 7,c7 is n modifi$ on or aft] ! date ( enactm5t ( ! ,v]ify+ ,accurate ,lead+-edge ,,ivct ,developm5t ,act ( #bjbj by its initial develop] 7or ano!r p]son7 9 a mann] su* t ! te/ is a new 9 vitro cl9ical te/ "u subsection 7l74 7#c7 ,modifications ,9 ! case ( a modification to an vitro cl9ical te/ t is exempt z specifi$ 9 p>agraph 7#a7 or det]m9es t su* modification is o!rwise n subject to prem>ket review pursuant to section #ehg;,a7l71 ! te/ cont9ues to qualify = su* exemption if ! p]son modify+ su* te/-- 7,a7 docum5ts ea* su* modification & ma9ta9s a summ>y ( ! basis = su* det]m9ation2 & 7,b7 provides su* docum5tation & summ>y to ! ,secret>y ^u reque/ or inspection4 7d7 ,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 m>ket$ subject to ! o!r applicable requirem5ts ( ?is ,act1 if ! 9 vitro cl9ical te/-- 7,a7 7i7 0 (f]$ = cl9ical use prior to ! date ( enactm5t ( ! ,v]ify+ ,accurate ,lead+-edge ,,ivct ,developm5t ,act ( #bjbj2 & 7ii7 imm$iately prior to su* date ( enactm5t 0 exempt pursuant to subsection 7l7 or 7m77#b7 ( section #eaj f ! requirem5ts = submission ( a report "u section #eaj7k72 or 7,b7 7i7 0 n (f]$ = cl9ical use prior to su* date ( enactm5t2 7ii7 is n a te/ plat=m2 & 7iii7 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 #eaj7l774 7#b7 ,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 p>agraph 7#b71 any special control t appli$ to a device )9 a pr$ecessor category imm$iately prior to ! date ( enactm5t ( ,v]ify+ ,accurate ,lead+-edge ,,ivct ,developm5t ,act ( #bjbj %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#c7 ,ne>-pati5t te/+ ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,v]ify+ ,accurate ,lead+-edge ,,ivct ,developm5t ,act ( #bjbj1 ! ,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 7e7 ,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 m>ket$ subject to ! o!r applicable requirem5ts ( ?is ,act1 includ+ section #ehg;,i7b77#f71 if su* te/ meets ! def9ition ( l[-risk "u section #ehg4 7#b7 ,li/ ( l[-risk te/s 7,a7 ,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 subsection4 7,b7 ,inclusion ,! li/ "u subp>agraph 7,a7 %all consi/ (-- 7i7 all 9 vitro cl9ical te/s & categories ( 9 vitro cl9ical te/s t are exempt f prem>ket review pursuant to subsection 7d77#a7 or 7d77#c72 & 7ii7 all 9 vitro cl9ical te/s & categories ( 9 vitro cl9ical te/s t are designat$ by ! ,secret>y pursuant to subp>agraph 7,c7 z l[-risk = purposes ( ?is subsection4 7,c7 ,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,b77i71 additional 9 vitro cl9ical te/s1 & categories ( 9 vitro cl9ical te/s1 z l[-risk 9 vitro cl9ical te/s = purposes ( ! exemption "u ?is subsection4 ,! ,secret>y may make su* a designation on ! ,secret>y's own initiative or 9 response to a reque/ by any p]son4 ,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[-risk 7z def9$ 9 section #ehg72 & 7ii7 su* o!r factors z ! ,secret>y det]m9es to be relevant to ! protection ( ! public heal?4 7f7 ,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 design$1 manufactur$1 & us$ )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 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,c7 is n int5d$ = te/+ donors1 donations1 & 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 compon5t or "p ( su* te/1 includ+ any reag5t1 is introduc$ into int]/ate comm]ce "u ! exemption "u subsection 7b77#a7 7relat+ to compon5ts or p>ts int5d$ = fur!r developm5t71 & 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;,j4 7g7 ,humanit>ian te/ exemption 7#a7 ,9 g5]al ,an 9 vitro cl9ical te/ is exempt f prem>ket review "u section #ehg;,b & may be lawfully m>ket$ subject to ! o!r applicable requirem5ts ( ?is ,act1 if-- 7,a7 su* 9 vitro cl9ical te/-- 7i7 is int5d$ = use = a disease or condition = :i* no m ?an #aj1jjj 7or su* o!r numb] det]m9$ by ! ,secret>y7 individuals w\ld be subject to negative or positive diagnosis by su* te/ 9 ! ,unit$ ,/ates p] ye>2 & 7ii7 is n int5d$ to diagnose a contagi\s disease or condition t is highly likely to result 9 fatal or irrev]sibly debilitat+ outcome & = :i* prompt & accurate diagnosis (f]s ! opportunity to mitigate a public heal? impact ( ! condition2 & 7,b7 ! 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 p>agraph2 & 7ii7 makes su* docum5tation available to ! ,secret>y ^u reque/4 7#b7 ,cross-ref]5c$ te/s ,9 ord] to be eligible = an exemption "u ?is subsection1 ! develop] ( a cross-ref]5c$ te/ %all submit a reque/ "u section #ehg;,h = in=mal fe$back4 7h7 ,cu/om te/s & l[-,volume te/s ,an 9 vitro cl9ical te/ is exempt f prem>ket review "u section #ehg;,b1 ! quality requirem5ts "u section #ehg;,j1 & ! notification requirem5ts "u section #ehg;,i1 & may be lawfully m>ket$ subject to ! o!r applicable requirem5ts ( ?is ,act1 if-- 7#a7 su* 9 vitro cl9ical te/-- 7,a7 is a l[-volume te/ p]=m$ 9 a laboratory 9 :i* x 0 develop$ or develop$ 9 a laboratory )9 ! same corporate organization ) ! laboratory 9 :i* su* te/ is p]=m$ & is adm9i/]$ to no m ?an #e pati5ts p] ye>1 unless o!rwise det]m9$ by ! ,secret>y2 or 7,b7 is a cu/om te/ develop$ or modifi$ to diagnose a unique pa?ology or physical condition ( a specific pati5t = :i* no o!r 9 vitro cl9ical te/ is comm]cially available 9 ! ,unit$ ,/ates1 & is-- 7i7 n int5d$ = use ) respect to o!r pati5ts2 & 7ii7 aft] ! developm5t ( ! cu/om te/1 n includ$ 9 any te/ m5u1 template te/ report1 or o!r promotional mat]ials1 & n o!rwise adv]tis$2 & 7#b7 ! develop] ( ! te/-- 7,a7 ma9ta9s docum5tation demon/rat+ t su* te/ meets & cont9ues to meet ! applicable crit]ia describ$ 9 p>agraph 7#a72 7,b7 makes su* docum5tation1 su* z a prescription ord] reque/+ ! cu/om te/ = an individual pati5t1 available to ! ,secret>y ^u reque/2 & 7,c7 in=ms ! ,secret>y1 on an annual basis1 9 a mann] prescrib$ by ! ,secret>y by guidance1 t su* te/ 0 introduc$ into int]/ate comm]ce4 7i7 ,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 activities1 includ+ ! collection & te/+ ( in=mation or biospecim5s1 conduct$1 support$1 reque/$1 ord]$1 requir$1 or au?oriz$ by a public heal? au?ority4 7#b7 ,limitation ,su* activities-- 7,a7 are limit$ to ^? necess>y to all[ a public heal? au?ority to id5tify1 monitor1 assess1 or inve/igate pot5tial public heal? signals1 onsets ( disease outbreaks1 or conditions ( public heal? importance 7includ+ tr5ds1 risk factors1 patt]ns 9 diseases1 or increases 9 injuries f us+ consum] products72 & 7,b7 include ^? associat$ ) provid+ timely situational aw>5ess & priority sett+ dur+ ! c\rse ( a ?reat to ! public heal? 7includ+ natural or man-made disa/]s & delib]ate attacks on ! ,unit$ ,/ates74 7#c7 ,exclusion ,an 9 vitro cl9ical te/ is n exclud$ f ! provisions ( ?is sub*apt] if su* te/ is int5d$ = use 9 mak+ cl9ical decisions = individual pati5ts4 7j7 ,law en=cem5t or employ] te/+ ,an 9 vitro cl9ical te/ t is int5d$ solely = use 9 =5sic analysis1 law en=cem5t activity1 or employm5t purposes is exempt f ! requirem5ts ( ?is ,act4 ,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$ = law en=cem5t or employm5t te/+ purposes1 is n int5d$ solely = use 9 law en=cem5t or employm5t te/+ = purposes ( ?is subsection4 7k7 ,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]1 z describ$ 9 section #ehg;,d7a77#b71 is exempt f prem>ket review "u section #ehg;,b4 7l7 ,modifi$ te/s 7#a7 ,9 g5]al ,an 9 vitro cl9ical te/ t is modifi$1 by ! initial develop] ( ! te/ or a diff]5t p]son1 is a new 9 vitro cl9ical te/ subject to ! requirem5ts ( ?is sub*apt] if ! modification-- 7,a7 affects ! analytical or cl9ical validity ( su* te/2 7,b7 causes ! te/ to no long] comply ) applicable mitigat+ measures "u section #ehg;,e or re/rictions "u section #ehg,n2 or 7,c7 z applicable1 affects ! safety ( an article = tak+ or d]iv+ specim5s f ! human body = a purpose describ$ 9 section #bja7ss77#a74 7#b7 ,exemptions ,not)/&+ p>agraph 7#a71 an 9 vitro cl9ical te/ t is modifi$ by ! initial develop] ( ! te/ or a diff]5t p]son is n a new 9 vitro cl9ical te/ if ! modification-- 7,a7 is a s(tw>e update t does n h an adv]se effect on ! analytical or cl9ical validity or result 9 an increas$ risk to pati5ts & consum]s2 7,b7 is made pursuant to me?ods or crit]ia includ$ 9 ! *ange protocol prem>ket submission1 am5dm5t1 or supplem5t approv$ by ! ,secret>y = ! 9 vitro cl9ical te/ be+ modifi$2 7,c7 is a label+ *ange t is appropriate to address pati5t or us] h>m2 or 7,d7 is a specim5-relat$ modification t is made to ext5d specim5 /ability or aligns ) ! data & in=mation submitt$ 9 an approv$ application = prem>ket review "u section #ehg;,b or an ord] issu$ "u section #ehg;,d4 7#c7 ,docum5tation ,:5 a p]son modifies an 9 vitro cl9ical te/ t 0 develop$ by ano!r p]son1 su* modifi$ te/ is exempt f ! requirem5ts ( ?is sub*apt] provid$ t su* p]son-- 7,a7 docum5ts ! modification t 0 made & ! basis = det]m9+ t ! modification1 consid]+ ! *anges individually & collectively1 0 n a type ( modification describ$ 9 p>agraph 7#a72 & 7,b7 provides su* docum5tation to ! ,secret>y ^u reque/ or inspection4 7m7 ,inve/igational use ,an 9 vitro cl9ical te/ = inve/igational use is exempt f ! requirem5ts ( ?is ,act1 except z provid$ 9 section #ehg,r4 7n7 ,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;,i = ! 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;,i = ! 9 vitro cl9ical te/2 & 7ii7 submit a supplem5tal 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 supplem5tal application "u section #ehg;,b7h7 if requir$1 :i*ev] is lat]4 ,! transf]ee or pur*as] %all update ! regi/ration & li/+ in=mation "u section #ehg;,i = ! 9 vitro cl9ical te/ )9 #ae cal5d> days ( ! effective date ( ! transf] or sale4 7#c7 ,transf] or sale ( te*nology c]tification 7,a7 ,requirem5ts = transf] or sale ( te*nology c]tification ,an unexpir$ 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;,d7b77#a72 & 7ii7 ma9ta9s1 ^u su* transf] or sale1 ! site1 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$1 ! transf]or or sell] %all submit a notice ( ! transf] or sale to ! ,secret>y & %all update ! regi/ration & li/+ in=mation "u section #ehg;,i = all 9 vitro cl9ical te/s cov]$ 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;,i = ! 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 ( subclause 7,a77ii7 are n met1 !n ! te*nology c]tification ord] _c be transf]r$ & ! transf]ee or pur*as] ( an 9 vitro cl9ical te/ mu/ submit an application = te*nology c]tification & obta9 a te*nology c]tification ord] prior to (f]+ ! te/ = cl9ical use4 7o7 ,g5]al laboratory equipm5t ,any in/rum5t t does n produce an analytical result1 & t functions z a compon5t ( pre-analytical proc$ures relat$ to 9 vitro cl9ical te/s1 is n subject to ! requirem5ts ( ?is sub*apt]1 provid$ t-- 7#a7 ! in/rum5t is op]at+ 9 a cl9ical laboratory t is c]tifi$ "u section #cec ( ! ,public ,heal? ,s]vice ,act2 & 7#b7 ! in/rum5t c be s]vic$ by ! manufactur] ( su* in/rum5t or1 if t manufactur] is no long] 9 bus9ess1 a ?ird p>ty ) ! ability to s]vice su* in/rum5t4 7p7 ,in/rum5t families ,9 ! case ( an in/rum5t family1 prem>ket approval "u section #ehg;,b7d7 ( "o v]sion ( ! 9 vitro cl9ical te/ is requir$1 & previ\s & updat$ v]sions ( ! same te/ )9 su* in/rum5t family %all be deem$ to be subject to ! approval pursuant to t section1 unless ! ,secret>y det]m9es o!rwise1 z set =? 9 guidance4 7q7 ,g5]al exemption au?ority ,! ,secret>y may1 by ord] publi%$ 9 ! ,f$]al ,regi/] foll[+ notice & an opportunity = comm5t1 exempt a class ( p]sons f any section "u ?is sub*apt] ^u a f9d+ t su* exemption is appropriate = ! protection ( ! public heal? & o!r relevant consid]ations4 7r7 ,regulations ,! ,secret>y may issue regulations to implem5t ?is sub*apt]4 #ehg;,b4 ,prem>ket review 7a7 ,9 g5]al ,no p]son %all introduce or deliv] = introduction into int]/ate comm]ce any 9 vitro cl9ical te/1 unless-- 7#a7 an approval ( an application fil$ pursuant to subsection 7c7 or 7d7 is effective ) respect to te/2 or 7#b7 ! te/ is exempt "u section #ehg;,a f prem>ket review "u ?is section4 7b7 ,transp>5cy & pr$ictability 7#a7 ,pre-submission meet+ or reque/ = in=mal fe$back ,pursuant to section #ehg;,h1 prior to fil+ an application "u subsection 7c7 or 7d71 any p]son may reque/ a meet+ or writt5 correspond5ce ) ! ,secret>y to discuss ! eligibility ( an 9 vitro cl9ical te/ = prem>ket review or o!r in=mation relat$ to ! fil+ ( an application4 ,! ,secret>y %all respond to su* reque/ )9 #de cal5d> days4 7#b7 ,/reaml9+ ( applications 7,a7 ,prem>ket application & te*nology c]tification ,if a p]son files a prem>ket application "u ?is section & provides any additional docum5tation requir$ "u section #ehg;,d1 ! 9 vitro cl9ical te/ t is ! subject ( ! application may be utiliz$ z ! repres5tative te/ review$ by ! ,secret>y to provide an approval = bo? a prem>ket application "u ?is section & a te*nology c]tification ord] "u section #ehg;,d4 7,b7 ,repres5tative assays = prem>ket approval ,) respect to a te*nology c]tification application fil$ "u section #ehg;,d1 ! repres5tative te/1 z describ$ 9 subp>agraph 7,a71 us$ to issue a te*nology c]tification ord] "u section #ehg;,d %all be deem$ a te/ ) prem>ket approval "u ?is section4 7c7 ,application 7#a7 ,fil+ ,any p]son may file ) ! ,secret>y an application = prem>ket approval ( an 9 vitro cl9ical te/4 7#b7 ,application cont5t ,an application submitt$ "u p>agraph 7#a7 ) respect to an 9 vitro cl9ical te/ %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 int5d$ use2 7iv7 an explanation reg>d+ te/ function & any significant p]=mance *>act]i/ics2 & 7v7 an explanation ( h[ ! developm5t & validation activities support ! te/ meet+ ! applicable /&>d4 7,b7 ,a summ>y ( ! data & in=mation 9 ! application = ! 9 vitro cl9ical te/1 includ+-- 7i7 a brief description ( any exi/+ alt]native practices or proc$ures = diagnos+ ! disease or condition = :i* ! 9 vitro cl9ical te/ is int5d$1 z applicable2 7ii7 a brief description ( ! =eign & dome/ic m>ket+ hi/ory ( ! te/1 if any1 includ+ a li/ ( all c\ntries 9 :i* ! te/ has be5 m>ket$ & a li/ ( all c\ntries 9 :i* ! te/ has be5 )drawn f m>ket+ = any reason relat$ to ! applicable /&>d ( ! 9 vitro cl9ical te/1 if kn[n by ! applicant2 7iii7 a summ>y ( ! any /udies submitt$ = su* te/1 includ+ a description ( ! objective ( ! /udy1 a description ( ! exp]im5tal design ( ! /udy1 a brief description ( h[ ! data 7 collect$ & analyz$1 a brief description ( ! results ( ! te*nical data submitt$1 & a brief description ( any noncl9ical or cl9ical /udies2 7iv7 a risk assessm5t ( ! te/2 & 7v7 conclusions drawn f any /udies describ$ 9 clause 7iii71 includ+ a discussion demon/rat+ t ! data & in=mation 9 ! application con/itute valid sci5tific evid5ce & meet ! applicable /&>d "u section #ehg7aj71 an explanation ( h[ ! developm5t & validation activities1 z applicable1 support t ! te/ meets ! applicable /&>d "u section #ehg7aj71 & a discussion ( any adv]se effects ( ! te/ on heal? & proposals to mitigate ^? risks1 if any4 7,c7 ,! signature ( ! p]son fil+ ! prem>ket application or an au?oriz$ repres5tative4 7,d7 ,a bibliography ( all publi%$ reports reasonably kn[n to ! applicant relat$ to su* te/ & a discussion ( data & in=mation relevant to ! evaluation ( ! applicable /&>d t may be met by su* te/4 7,e7 ,a /atem5t t ! applicant believes to ! be/ ( ! applicant's k t all data & in=mation submitt$ to ! ,secret>y are tru?ful & accurate & t no mat]ial fact has be5 omitt$ 9 ! application4 7,f7 ,except z provid$ "u subsection 7d71 applicable 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;,j4 7,g7 ,in=mation demon/rat+ compliance ) any relevant-- 7i7 mitigat+ measures "u section #ehg;,e2 & 7ii7 /&>ds e/abli%$ or recogniz$ "u section #ead prior to ! date ( enactm5t ( ! ,v]ify+ ,accurate ,lead+-edge ,,ivct ,developm5t ,act ( #bjbj1 or1 aft] applicable /&>ds are e/abli%$ or recogniz$ "u section #ehg,q1 ) su* /&>ds4 7,h7 ,valid sci5tific evid5ce to support analytical & cl9ical validity ( ! te/1 :i* %all include-- 7i7 summ>y in=mation = all support+ validation /udies p]=m$2 & 7ii7 raw data1 su* z tabulations ( data & results z requir$ "u section #had4bj7;b77#f77;ii7 ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations72 7iii7 = noncl9ical laboratory /udies involv+ ! te/1 a /atem5t t /udies 7 conduct$ 9 compliance ) applicable good laboratory practices2 & 7iv7 = inve/igations involv+ human subjects1 /atem5ts t any cl9ical inve/igation involv+ human subjects 0 conduct$ 9 compliance ) applicable-- 7,i7 in/itutional review bo>d regulations2 7,,ii7 in=m$ cons5t regulations2 & 7,,iii7 inve/igational use requirem5ts 9 section #ehg,r4 7,i7 ,to ! ext5t ! application seeks au?orization to make modifications to ! te/ )9 ! scope ( ! approval1 a *ange protocol t includes validation proc$ures & acceptance crit]ia = anticipat$ modifications t c\ld be made to ! te/ )9 ! scope ( ! approval4 7,j7 ,propos$ label+1 9 accordance ) ! requirem5ts ( section #ehg,k4 7,k7 ,su* o!r data or in=mation z ! ,secret>y may require 9 accordance ) ! lea/ burd5some requirem5ts ( subsection 7j74 7#c7 ,guidance = prem>ket & special prem>ket applications ,9 accordance ) section #e ( ! ,v]ify+ ,accurate ,lead+-edge ,,ivct ,developm5t ,act ( #bjbj1 ! ,secret>y %all issue draft guidance detail+ ! in=mation to be provid$ 9 a prem>ket application & special prem>ket application "u ?is section4 ,! ,secret>y %all issue f9al guidance n lat] ?an #ij cal5d> days aft] ! close ( ! comm5t p]iod = su* guidance4 7#d7 ,refuse to file a prem>ket or special prem>ket application ,if1 aft] receipt ( an application "u ?is section1 ! ,secret>y refuses to file su* application1 ! ,secret>y %all provide to ! develop]1 )9 #fj cal5d> days ( receipt ( su* application1 a description ( ! reason = su* refusal1 & id5tify ! in=mation requir$1 if any1 to all[ = ! fil+ ( ! application4 7#e7 ,sub/antive review = defici5t application ,if1 aft] receipt ( an application "u ?is section1 ! ,secret>y det]m9es t any portion ( su* application is defici5t1 ! ,secret>y %all provide to ! applicant1 )9 #ge cal5d> days ( receipt ( su* application1 a description ( su* defici5cies & id5tify ! in=mation requir$ to correct su* defici5cies4 7d7 ,special prem>ket review 7#a7 ,9 g5]al ,any p]son may file ) ! ,secret>y an application = special prem>ket approval =-- 7,a7 an in/rum5t2 7,b7 a specim5 receptacle2 7,c7 an 9 vitro cl9ical te/ eligible = a te*nology c]tification ord] "u section #ehg;,d2 or 7,d7 a fir/-(-a-k9d te/1 unless x is a high-risk te/1 a direct-to-consum] te/1 or cross-ref]5c$ te/ t does n h mitigat+ measures4 7#b7 ,application cont5t ,an application "u p>agraph 7#a7 %all include-- 7,a7 ! in=mation requir$ = applications submitt$ "u subsection 7c77#b71 except t applications "u p>agraph 7#a7 ne$ n include-- 7i7 quality requirem5t in=mation2 or 7ii7 raw data unless explicitly reque/$ by ! ,secret>y2 7,b7 9 ! case ( a specim5 receptacle1 safety in=mation2 & 7,c7 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 ,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,p ne$ n occur unless reque/$ by ! ,secret>y4 7e7 ,in/rum5t family ,:5 an 9 vitro cl9ical te/ has be5 approv$1 or is o!rwise legally m>ket$1 = use on a specific approv$ or legally m>ket$ in/rum5t )9 an in/rum5t family1 a submission "u ?is section %all n be requir$ = t 9 vitro cl9ical te/ 9 ord] = x to be us$ on a new in/rum5t )9 t in/rum5t's family4 7f7 ,am5dm5ts to an application 7#a7 ,9 g5]al ,an applicant may am5d an orig9al or supplem5tal application "u subsection 7c7 or 7d74 7#b7 ,requir$ am5dm5t or supplem5t ,an applicant %all am5d or supplem5t an application submitt$ "u subsection 7c7 or 7d7 if ! applicant becomes aw>e ( in=mation t-- 7,a7 c\ld reasonably affect an evaluation ( :e!r ! applicable /&>d has be5 met2 or 7,b7 c\ld reasonably affect ! /atem5t ( contra9dications1 w>n+s1 precautions1 & adv]se reactions 9 ! propos$ label+4 7#c7 ,reque/ = am5dm5t or supplem5t ,! ,secret>y may reque/ t an applicant am5d or supplem5t an application "u subsection 7c7 or 7d7 ) any in=mation necess>y = review "u ?is section4 7g7 ,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 7c7 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 7d7 is accept$ = submission1 ! ,secret>y1 aft] consid]+ any applicable report & recomm5dations pursuant to advisory committees "u section #ehg;,g1 or prior to ! e/abli%m5t ( su* advisory committees1 any recomm5dations by a classification panel "u section #eac1 %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 ! int5d$ 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 7c7 ) respect to an 9 vitro cl9ical te/ if ! ,secret>y f9ds t !re is a reasonable assurance t ! applicable /&>d is met1 &-- 7i7 except z provid$ "u subsection 7d71 ! applicant is 9 compliance ) applicable quality requirem5ts 9 section #ehg;,j or z o!rwise specifi$ 9 a condition ( approval1 or ma9ta9s ! docum5tation requir$ to be 9 compliance ) su* requirem5ts if ! applicant is n requir$ to submit su* docum5tation z a "p ( ! application "u ?is section2 7ii7 ! application does n conta9 a false /atem5t ( mat]ial fact2 7iii7 bas$ on a fair evaluation ( all mat]ial facts1 ! propos$ label+ is tru?ful & non-mislead+ & complies ) ! requirem5ts ( section #ehg,k2 7iv7 except z provid$ "u subsection 7d71 ! applicant p]mits1 if reque/$1 au?oriz$ employees ( ! ,food & ,drug ,adm9i/ration & p]sons accr$it$ "u section #ehg,p an opportunity-- 7,i7 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&$1 or o!rwise 9 violation ( ?is ,act2 & 7,,ii7 to view & to copy & v]ify all records p]t95t to ! application & ! 9 vitro cl9ical te/2 7v7 ! te/ con=ms ) any applicable p]=mance /&>ds "u section #ehg,q & any applicable mitigat+ measures "u section #ehg;,e2 & 7vi7 all noncl9ical laboratory /udies & cl9ical inve/igations involv+ human subjects t are describ$ 9 ! application 7 conduct$ 9 a mann] t meets ! requirem5ts ( ?is section4 7,b7 ,conditions ( approval ,an ord] approv+ an application pursuant to ?is p>agraph may require conditions ( approval = ! 9 vitro cl9ical te/1 includ+ con=mance ) p]=mance /&>ds "u section #ehg,q & re/rictions "u section #ehg,n4 7,c7 ,fir/-(-a-k9d te/ ,= a fir/-(-a-k9d 9 vitro cl9ical te/1 an ord] approv+ an application pursuant to ?is p>agraph-- 7i7 may impose requirem5ts = te/s ) ! same indications = use1 includ+ con=mance ) p]=mance /&>ds "u section #ehg,q & mitigat+ measures "u section #ehg;,e1 & comply ) re/rictions "u section #ehg,n2 & 7ii7 %all indicate :e!r subsequ5t 9 vitro cl9ical te/s ) ! same int5d$ use may meet an exemption set =? 9 section #ehg;,a4 7,d7 ,publication ,! ,secret>y %all publi% ea* ord] approv+ an application pursuant to ?is p>agraph on ! public website ( ! ,food & ,drug ,adm9i/ration & make publicly available a summ>y ( ! data us$ to grant ! approval1 except to ! ext5t ! ,secret>y det]m9es t su* ord]-- 7i7 conta9s comm]cially confid5tial or trade secret in=mation2 or 7ii7 relates to national security or c\nt]measures is re/rict$ f disclosure pursuant to /atutory provisions o!r ?an ?is section4 7#c7 ,review ( d5ials ,an applicant ^: application submitt$ "u subsection 7c7 or 7d7 has be5 d5i$ approval 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,o4 7h7 ,supplem5ts to an application 7#a7 ,risk ,analysis ,prior to implem5t+ any modification to an 9 vitro cl9ical te/1 ! hold] ( ! application approv$ "u subsection 7c7 or 7d7 = su* te/ %all p]=m risk analyses 9 accordance ) section #ehg;,j1 unless su* modification is includ$ 9 ! *ange protocol submitt$ by ! applicant & approv$ "u ?is section or exempt "u section #ehg;,a7l74 7#b7 ,supplem5t requirem5t 7,a7 ,9 g5]al ,except z provid$ 9 subp>agraph 7,b71 or o!rwise specifi$ by ! ,secret>y1 ! hold] ( ! application approv$ "u subsection 7g7 = an 9 vitro cl9ical te/ %all submit to ! ,secret>y & receive approval ( a supplem5t be=e implem5t+ a modification to ! te/1 unless su* modification is exempt "u section #ehg;,a7l74 7,b7 ,adju/m5ts to *ange protocol ,a p]son may submit "u ?is p>agraph a supplem5tal application adju/+ ! *ange protocol ( ! te/ at any "t aft] ! initial fil+ ( an application "u subsection 7c7 or 7d74 7,c7 ,exceptions ,subject to subp>agraphs 7,d7 & 7,e71 & s long z ! hold] ( an approv$ application submitt$ "u subsection 7c7 or 7d7 = an 9 vitro cl9ical te/ does n add a manufactur+ site1 or *ange activities at an exi/+ manufactur+ site1 ) respect to ! te/1 ! hold] may1 )\t prior approval ( a supplem5t1 implem5t ! foll[+ modifications to ! te/3 7i7 ,modifications includ$ 9 & implem5t$ 9 accordance ) an approv$ *ange protocol "u subsection 7c77#b77;,i74 7ii7 ,modifications t d n *ange-- 7,i7 ! analytical or cl9ical validity ( ! te/2 7,,ii7 ! int5d$ use ( ! te/ unless provid$ "u an approv$ *ange protocol "u subsection 7c77#b77;,i72 or 7,,iii7 ! safety ( ! specim5 receptacles4 7iii7 ,label+ *anges to address a safety conc]n4 7iv7 ,modifications t are exempt "u section #ehg;,a7l74 7,d7 ,report+ = *ange protocol modifications ,z a compon5t ( ! report requir$ "u subsection 7k71 ! hold] ( an application approv$ "u subsection 7g7 = an 9 vitro cl9ical te/ %all-- 7i7 report any modification to ! te/ describ$ 9 clause 7i7 or 7ii7 ( subp>agraph 7,b7 9 ! next annual report = ! te/ "u subsection 7k7 foll[+ ! date on :i* ! te/1 ) su* modification1 is introduc$ into int]/ate comm]ce2 & 7ii7 include 9 su* report-- 7,i7 a description ( ! modification2 & 7,,ii7 z applicable1 a summ>y ( ! analytical validity & cl9ical validity ( ! te/1 z modifi$1 & any *anges to acceptance crit]ia4 7,e7 ,report+ = o!r category ( exceptions ,! hold] ( ! application approv$ "u subsection 7c7 or 7d7 = an 9 vitro cl9ical te/ %all-- 7i7 report to ! ,secret>y any modification to ! te/ describ$ 9 clause 7iii7 ( subp>agraph 7,c7 n m ?an #fj days aft] ! date on :i* ! te/1 ) ! modification1 is introduc$ into int]/ate comm]ce2 & 7ii7 include 9 ! report-- 7,i7 a summ>y ( ! relevant *ange or *anges2 7,,ii7 ! rationale = implem5t+ su* *ange or *anges2 & 7,,iii7 a description ( h[ ! *ange or *anges 7 evaluat$4 7,f7 ,reque/ = supplem5t ,^u review ( ! in=mation receiv$ "u subp>agraph 7,d7 & a f9d+ t ! relevant modification is inconsi/5t ) ! /&>d specifi$ "u subp>agraph 7,c71 ! ,secret>y may require a supplem5t "u subp>agraph 7,a74 ,if ! ,secret>y det]m9es t a supplem5t "u subp>agraph 7,a7 is requir$1 ! ,secret>y %all notify ! applicant ( su* det]m9ation4 ,su* notification %all include a ju/ification = ! submission ( a supplem5t4 ,prior to ! submission ( a supplem5t "u ?is subp>agraph1 ! applicant may reque/ a meet+ or writt5 correspond5ce to ga9 ag5cy fe$back z to ! necessity ( su* supplem5tal fil+4 ,! ,secret>y %all respond to su* meet+ reque/ )9 #cj cal5d> days ( receipt4 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-- 7i7 a description ( ! modification2 7ii7 data to demon/rate t ! applicable /&>d is met2 7iii7 acceptance crit]ia2 & 7iv7 any revis$ label+2 & 7,b7 = manufactur+ site *anges-- 7i7 ! matt] 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;,j4 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$+ p>agraphs if ! data reque/ is 9 accordance ) ! lea/ burd5some requirem5ts "u subsection 7j74 7#e7 ,conditions ( ,approval ,9 an ord] approv+ a supplem5t "u ?is subsection1 ! ,secret>y may require conditions ( approval = ! 9 vitro cl9ical te/1 includ+ compliance ) re/rictions "u section #ehg,n & con=mance to p]=mance /&>ds "u section #ehg,q4 7#f7 ,approval ,! ,secret>y %all approve a supplem5t "u ?is subsection if-- 7,a7 ! data demon/rate t ! modifi$ 9 vitro cl9ical te/ meets ! applicable /&>d2 & 7,b7 ! hold] ( ! application approv$ "u subsection 7g7 = ! 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 subsection1 except t su* publication %all exclude-- 7,a7 comm]cial confid5tial or trade secret in=mation2 & 7,b7 any o!r in=mation t ! ,secret>y det]m9es to relate to national security or c\nt]measures or to be re/rict$ f disclosure pursuant to ano!r provision ( law4 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,o4 7i7 ,)drawal & tempor>y susp5sion ( approval 7#a7 ,ord] )draw+ approval 7,a7 ,9 g5]al ,! ,secret>y may1 )9 #aj cal5d> days ( 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 9 subsection 7g7 are no long] met2 or 7ii7 !re is a reasonable likelihood t ! te/ w\ld cause dea? or s]i\s adv]se heal? consequ5ces1 includ+ by caus+ ! abs5ce1 delay1 or discont9uation ( life-sav+ or life su/a9+ m$ical treatm5t4 7,b7 ,cont5t ,an ord] "u subp>agraph 7,a7 )draw+ approval ( an application %all /ate ea* gr\nd = )drawal & %all notify ! hold] ( su* application #fj cal5d> days prior to issu+ su* ord]4 7,c7 ,publication ,! ,secret>y %all publi% any ord] "u subp>agraph 7,a7 on ! public website ( ! ,food & ,drug ,adm9i/ration1 except t su* publication %all exclude-- 7i7 comm]cial confid5tial or trade secret in=mation2 & 7ii7 any o!r in=mation t ! ,secret>y det]m9es to relate to national security or c\nt]measures or to be re/rict$ f disclosure pursuant to ano!r provision ( law4 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]m9es !re is a reasonable likelihood t ! 9 vitro cl9ical te/ w\ld cause dea? or s]i\s adv]se heal? consequ5ces1 includ+ by caus+ ! abs5ce1 delay1 or discont9uation ( life-sav+ or life-su/a9+ m$ical treatm5t1 ! ,secret>y %all by ord] tempor>ily susp5d ! approval ( ! application4 ,if ! ,secret>y issues su* an ord]1 ! ,secret>y %all proce$ exp$iti\sly "u p>agraph 7#a7 to )draw approval ( su* application4 7j7 ,lea/ burd5some requirem5ts 7#a7 ,9 g5]al ,9 c>ry+ out ?is sub*apt]1 ! ,secret>y %all consid] ! lea/ burd5some means necess>y to provide a reasonable assurance ( analytical & cl9ical validity1 or applicable /&>d1 & o!r regulatory requirem5ts1 z det]m9$ by ! ,secret>y4 7#b7 ,necess>y def9$ ,= purposes ( p>agraph 7#a7 & p>agraph 7#c71 ! t]m necess>y means ! m9imum requir$ in=mation t w\ld support a det]m9ation by ! ,secret>y t ! application provides a reasonable assurance ( analytical & cl9ical validity1 or o!r applicable /&>d or regulatory requirem5t1 z det]m9$ by ! ,secret>y4 7#c7 ,consid]ation ( role ( po/m>ket in=mation ,= purposes ( ?is subsection1 ! ,secret>y %all consid] ! role ( po/m>ket in=mation 9 det]m9+ ! lea/ burd5some appropriate means necess>y to demon/rate t ! applicable /&>d & o!r regulatory requirem5ts h be5 met4 7k7 ,annual report 7#a7 ,9 g5]al ,unless ! ,secret>y specifies o!rwise1 ! hold] ( an approv$ application "u ?is section %all submit an annual report ea* ye> at a "t designat$ by ! ,secret>y 9 ! approval ord]4 ,su* report %all-- 7,a7 id5tify all modifications requir$ to be report$ t an approv$ application hold] has made to any te/ t is cov]$ by ! approval ord]1 includ+ any modification t requires a supplem5t "u subsection 7h77#b72 & 7,b7 include any o!r in=mation requir$ by ! ,secret>y4 7#b7 ,exception ,! annual report+ requirem5t 9 p>agraph 7#a7 %all n apply to 9 vitro cl9ical te/s t are deem$ to h a prem>ket approval bas$ on a prior approval "u section #eae7;c71 cle>ance "u section #eaj7k71 or au?orization "u section #eac7;f74 7l7 ,s]vice ( ord]s ,ord]s ( ! ,secret>y "u ?is section ) respect to applications "u subsection 7c7 or 7d7 or supplem5ts "u subsection 7h7 %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 #ehg;,c4 ,break?r\gh 9 vitro cl9ical te/s 7a7 ,9 ,g5]al ,! purpose ( ?is section is to enc\rage ! ,secret>y & provide ! ,secret>y ) suffici5t au?ority 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 conditions comp>$ to exi/+ approv$ or prec]tifi$ alt]natives2 & 7#b7 is a te/-- 7,a7 t repres5ts a break?r\gh te*nology2 7,b7 = :i* no approv$ or prec]tifi$ alt]native exi/s2 7,c7 t (f]s a cl9ically mean+ful advantage ov] exi/+ approv$ or prec]tifi$ alt]natives1 includ+ ! pot5tial1 comp>$ to exi/+ approv$ or prec]tifi$ alt]natives1 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 approval "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 to ! submission ( an application "u section #ehg;,b1 & %all include in=mation demon/rat+ t ! te/ is eligible = designation "u 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 "u section #ehg;,b is d5i$4 ,su* te/ w\ld be eligible = designation ^u a new reque/ = su* designation4 7,b7 ,exception ,! ,secret>y may n )draw a designation grant$ "u ?is subsection bas$ on ! subsequ5t approval or te*nology c]tification ( ano!r te/ t-- 7i7 is designat$ "u ?is section2 or 7ii7 0 giv5 priority review "u section #eae;,b4 7e7 ,actions ,= purposes ( exp$it+ ! developm5t & review ( 9 vitro cl9ical te/s "u ?is section1 ! ,secret>y may take ! actions & additional actions set =? 9 section #eae;,b7e7 :5 review+ su* te/s4 ,any ref]5ce or au?orization 9 section #eae;,b7e7 ) respect to a device %all be deem$ a ref]5ce or au?orization ) respect to an 9 vitro cl9ical te/ = purposes ( ?is section4 7f7 ,guidance 7#a7 ,9 g5]al ,n lat] ?an "o ye> aft] ! date ( enactm5t ( ! ,v]ify+ ,accurate ,lead+-edge ,,ivct ,developm5t ,act ( #bjbj1 ! ,secret>y %all issue draft 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 7#b7 ,process ,prior to f9aliz+ ! guidance "u p>agraph 7#a71 ! ,secret>y %all seek public comm5t on ! draft guidance4 ,! ,secret>y %all issue f9al guidance "o ye> aft] ! close ( ! comm5t p]iod = ! draft guidance4 7g7 ,annual ,report ,unless o!rwise specifi$ by ! ,secret>y1 ! requirem5ts "u section #ehg;,b7k7 apply to 9 vitro cl9ical te/s designat$ "u ?is section4 7h7 ,s]vice ( ord]s ,ord]s ( ! ,secret>y "u ?is 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 8 la/ kn[n address 9 ! records ( ! ,secret>y4 #ehg;,d4 ,te*nology c]tification 7a7 ,9 g5]al 7#a7 ,eligibility ,any eligible p]son may seek a te*nology c]tification 9 accordance ) ?is section4 7#b7 ,exception ,an 9 vitro cl9ical te/ is exempt f prem>ket review "u section #ehg;,b if ! develop] is eligible "u ?is section & ! 9 vitro cl9ical te/-- 7,a7 is an eligible 9 vitro cl9ical te/ "u subsection 7b77#b72 & 7,b7 falls )9 ! scope ( a te*nology c]tification ord] issu$ "u ?is section1 & su* ord] is 9 effect4 7b7 ,eligibility 7#a7 ,eligible p]son ,9 ?is section1 ! t]m eligible p]son means an 9 vitro cl9ical te/ develop] unless1 at ! "t su* p]son seeks or w\ld seek te*nology c]tification ord]1 ! p]son-- 7,a7 has be5 f\nd to h committ$ a significant violation ( section #cec ( ! ,public ,heal? ,s]vice ,act1 unless-- 7i7 su* violation occurr$ m ?an #e ye>s prior to ! date on :i* su* te*nology c]tification ord] is or w\ld be s\ght2 7ii7 su* violation has be5 resolv$2 or 7iii7 su* violation is n p]t95t to any 9 vitro cl9ical te/ )9 ! scope ( ! te*nology c]tification ord] t su* p]son seeks or w\ld seek2 or 7,b7 su* p]son fails to ma9ta9 requir$ c]tifications "u section #cec ( ! ,public ,heal? ,s]vice ,act2 7,c7 has be5 f\nd to h submitt$ in=mation t-- 7i7 makes false or mislead+ /atem5ts ab\t a te*nology c]tification ord] previ\sly issu$ or an application approv$ "u section #ehg;,b2 or 7ii7 violates any requirem5t ( ?is sub*apt] relat$ to te*nology c]tification "u ?is section or approval "u section #ehg;,b1 :]e su* violation exposes p]sons to s]i\s risk ( illness1 injury1 or dea?4 7#b7 ,eligible 9 vitro cl9ical te/ ,an 9 vitro cl9ical te/ is eligible "u subsection 7a77#b7 = exemption f prem>ket review "u section #ehg;,b unless-- 7,a7 su* te/ is-- 7i7 a compon5t or "p ( an 9 vitro cl9ical te/ z describ$ "u section #bja7ss77#a77;,b77v72 7ii7 an in/rum5t "u section #bja7ss77#a77;,b77ii72 7iii7 a specim5 receptacle "u section #bja7ss77#a77;,b77iii72 or 7iv7 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 or 7,b7 unless o!rwise p]mitt$ pursuant to section #ehg;,f1 su* te/ is-- 7i7 a fir/-(-a-k9d 9 vitro cl9ical te/2 7ii7 a te/ sy/em = home use2 7iii7 a high-risk 9 vitro cl9ical te/2 7iv7 a cross-ref]5c$ 9 vitro cl9ical te/2 or 7v7 a direct-to-consum] 9 vitro cl9ical te/4 7c7 ,public meet+ & input 7#a7 ,public docket ,n lat] ?an #cj days aft] ! date ( enactm5t ( ! ,v]ify+ ,accurate ,lead+-edge ,,ivct ,developm5t ,act ( #bjbj1 ! ,secret>y %all e/abli% a public docket to receive comm5ts conc]n+ recomm5dations = implem5tation ( ?is section1 includ+ crit]ia & proc$ures = subsections 7e7 ?r\gh 7j74 ,! public docket %all rema9 op5 = ! duration ( "t t ?is section rema9s 9 effect4 7#b7 ,public meet+ ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,v]ify+ ,accurate ,lead+-edge ,,ivct ,developm5t ,act ( #bjbj1 ! ,secret>y %all conv5e a public meet+ to :i* /akehold]s f organizations repres5t+ pati5ts & consum]s1 academia1 & ! 9 vitro cl9ical te/ indu/ry are invit$ 9 ord] to discuss compon5ts ( ! te*nology c]tification process includ+ application requirem5ts1 inspections1 alignm5t ) ?ird-p>ty accr$itors1 & ! def9ition ( te*nology "u section #ehg7ag74 ,! public meet+ %all be assign$ a docket numb] by ! ,commission] ( ,food & ,drugs & made available = ! submission ( public comm5ts4 7d7 ,guidance ,9 accordance ) section #e ( ! ,v]ify+ ,accurate ,lead+-edge ,,ivct ,developm5t ,act ( #bjbj1 ! ,secret>y %all issue a draft guidance on te*nology review includ+ describ+ crit]ia or proc$ures relat+ to te*nology review "u ?is section1 :i* %all be subject to public comm5t = a m9imum ( #fj days f issuance prior to f9aliz+ su* guidance docum5ts aft] consid]+ ! comm5ts receiv$4 ,! guidance %all include an outl9e ( ! application & rec]tification process1 opportunities to meet ) (ficials ( ! ,food & ,drug ,adm9i/ration1 plans to /reaml9e inspections1 & a li/ ( applicable te*nologies4 ,! guidance %all be updat$ z appropriate1 & n less frequ5tly ?an ea* "t ! ,secret>y id5tifies a unique te*nology4 7e7 ,application = te*nology c]tification 7#a7 ,9 g5]al ,a p]son 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 ,an application = te*nology c]tification %all conta9-- 7,a7 a /atem5t id5tify+ ! scope ( ! propos$ te*nology c]tification1 :i* %all be no broad] ?an a s+le te*nology int5d$ to be (f]$ "u ! application2 7,b7 in=mation %[+ t ! p]son seek+ a te*nology c]tification ord] is an eligible p]son "u subsection 7b77#a72 7,c7 in=mation %[+ t ! me?ods us$ 91 & ! facilities & controls us$ =1 ! developm5t ( eligible 9 vitro cl9ical te/s cov]$ by ! scope ( ! te*nology c]tification con=m to ! applicable quality requirem5ts ( section #ehg;,j2 7,d7 proc$ures = analytical validation1 includ+ all proc$ures = validation1 v]ification1 & acceptance crit]ia1 & an explanation z to h[ su* proc$ures1 :5 us$1 provide a reasonable assurance ( analytical validity ( all eligible 9 vitro cl9ical te/s )9 ! propos$ scope ( te*nology c]tification ord]2 7,e7 in=mation %[+ t ! p]son has an e/abli%$ cl9ical program1 includ+ proc$ures = cl9ical validation1 includ+ all proc$ures = validation1 v]ification1 & acceptance crit]ia1 & an explanation z to h[ su* proc$ures1 :5 us$1 provide a reasonable assurance ( cl9ical validity ( all eligible 9 vitro cl9ical te/s )9 ! propos$ scope ( te*nology c]tification ord]2 7,f7 a notification "u section #ehg;,i = ea* applicable 9 vitro cl9ical te/ t ! develop] plans to (f] initially ^u receiv+ a te*nology c]tification ord] & t w\ld be introduc$ or deliv]$ = introduction into int]/ate comm]ce ^u ! issuance ( ! te*nology c]tification ord]2 7,g7 in=mation conc]n+ "o or m repres5tative 9 vitro cl9ical te/s1 includ+-- 7i7 "o ( ! te/s )9 ! scope ( ! te*nology c]tification application ) ! greate/ analytical complexity at ! "t ( ! fil+ ( ! application "u ?is section t w\ld be introduc$ or deliv]$ = introduction into int]/ate comm]ce ^u ! issuance ( ! te*nology c]tification ord] to s]ve z ! repres5tative te/ & validate & run )9 ! develop]'s /at$ scope1 & a rationale = su* selection2 7ii7 ! in=mation specifi$ 9 subsection 7c7 or 7d7 ( section #ehg;,b = ! repres5tative 9 vitro cl9ical te/ or te/s1 except t raw data %all be provid$ = any su* 9 vitro cl9ical te/ unless ! ,secret>y det]m9es o!rwise2 7iii7 an explanation ( ! *oice ( ! repres5tative 9 vitro cl9ical te/ or te/s = ! te*nology c]tification application & h[ su* te/ adequately demon/rates ! range ( proc$ures t ! develop] includes 9 ! application "u subp>agraphs 7,c71 7,d71 7,e71 & 7,f72 & 7iv7 a brief explanation ( ! ways 9 :i* ! proc$ures includ$ 9 ! application "u subp>agraphs 7,c71 7,d71 7,e71 & 7,f7 h be5 appli$ to ! repres5tative 9 vitro cl9ical te/ or te/s2 7,h7 su* o!r in=mation relevant to ! subject matt] ( ! application z ! ,secret>y may require2 & 7,i7 a /atem5t t ! applicant believes to ! be/ ( ! applicant's k t all data & in=mation submitt$ to ! ,secret>y are tru?ful & accurate & t no mat]ial fact has be5 omitt$4 7f7 ,action on an application = te*nology c]tification 7#a7 ,secret>y response 7,a7 ,9 g5]al ,z promptly z practicable1 & no lat] ?an #ij days aft] receipt ( an application "u subsection 7c71 ! ,secret>y %all-- 7i7 issue a te*nology c]tification ord] grant+ ! application1 :i* %all specify ! scope ( ! te*nology c]tification1 if ! ,secret>y f9ds t all ( ! gr\nds 9 p>agraph 7#c7 are met2 or 7ii7 d5y ! application if ! ,secret>y f9ds 7& sets =? ! basis ( su* f9d+ z "p ( or accompany+ su* d5ial7 t "o or m gr\nds = grant+ ! application specifi$ 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 ,if1 aft] receipt ( an application "u ?is section1 ! ,secret>y det]m9es t any portion ( su* application is defici5t1 ! ,secret>y1 n lat] ?an #ij days aft] receipt ( su* application1 %all provide to ! applicant a description ( su* defici5cies & id5tify ! in=mation requir$ to correct su* defici5cies4 7#c7 ,approval ,! ,secret>y %all grant a te*nology c]tification ord] "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 9 accordance ) subsection 7e77#b77;,d71 !re is a %[+ ( reasonable assurance ( analytical validity = all eligible 9 vitro cl9ical te/s )9 ! propos$ scope ( ! te*nology c]tification1 z evid5c$ by ! proc$ures = analytical validation2 7,b7 9 accordance ) subsection 7e77#b77;,e71 !re is a %[+ ( reasonable assurance ( cl9ical validity = all eligible 9 vitro cl9ical te/s )9 ! propos$ scope ( ! te*nology c]tification1 z evid5c$ by ! cl9ical program1 includ+ proc$ures = cl9ical validation2 7,c7 ! me?ods us$ 91 or ! 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;,j2 7,d7 bas$ on a fair evaluation ( all mat]ial facts1 ! applicant's propos$ label+ & adv]tis+ is n false or mislead+ 9 any p>ticul>2 7,e7 ! application does n conta9 a false /atem5t ( mat]ial fact2 7,f7 !re is a %[+ t ! repres5tative 9 vitro cl9ical te/ or te/s-- 7i7 meets ! applicable /&>d = approval2 & 7ii7 reasonably repres5t ! range ( proc$ures = analytical validation & cl9ical validation includ$ 9 ! application1 z applicable2 & 7,g7 ! applicant p]mits au?oriz$ employees ( ! ,food & ,drug ,adm9i/ration or p]sons accr$it$ "u ?is ,act 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/4 7#d7 ,review ( d5ials ,an applicant ^: application has be5 d5i$ may1 by petition fil$ on or be=e ! date t is #cj cal5d> days aft] ! date ^u :i* su* applicant receives notice ( su* d5ial1 obta9 review !re( 9 accordance ) section #ehg,o4 7g7 ,duration2 subsequ5t submissions 7#a7 ,ord] duration ,a te*nology c]tification ord] %all rema9 9 effect until ! e>li] (-- 7,a7 ! expiration ( su* te*nology c]tification ord] "u p>agraph 7#b72 or 7,b7 ! )drawal ( su* te*nology c]tification ord] "u subsection 7j74 7#b7 ,expiration ,an initial te*nology c]tification ord] issu$ "u subsection 7f77#c7 %all expire on su* date specifi$ by ! ,secret>y t is n lat] ?an #d ye>s aft] ! date t su* ord] is issu$1 except t if an application = r5ewal "u p>agraph 7#c7 has be5 receiv$ n lat] ?an #cj days prior to ! expiration ( su* ord] "u ?is p>agraph1 su* ord] %all expire on ! date on :i* ! ,secret>y has grant$ or d5i$ ! application = r5ewal4 ,any su* subsequ5t r5ewal ( a te*nology c]tification %all expire on su* date specifi$ by ! ,secret>y t is n lat] ?an #d ye>s aft] ! date t su* te*nology c]tification ord] is issu$4 7#c7 ,r5ewal 7,a7 ,9 g5]al ,any p]son ) a te*nology c]tification ord] 9 effect ) respect to developm5t ( 9 vitro cl9ical te/s may seek r5ewal ( su* ord] provid$ t-- 7i7 su* p]son is an eligible p]son "u subsection 7b77#a72 & 7ii7 none ( ! in=mation specifi$ 9 subsection 7e77#b7 has sub/antially *ang$1 except z describ$ 9 supplem5ts approv$ "u p>agraph 7#d74 7,b7 ,cont5t ,an application = r5ewal "u ?is p>agraph %all include in=mation conc]n+ "o or m repres5tative 9 vitro cl9ical te/s 9 accordance ) subsection 7e77#b77;,g71 except t su* repres5tative te/ or te/s %all be diff]5t f ! repres5tative te/ or te/s reli$ ^u z ! repres5tative assay 9 any prior te*nology c]tification t has n yet be5 review$1 if applicable4 7,c7 ,process ,! ,secret>y's action on an application = r5ewal ( te*nology c]tification "u ?is p>agraph %all be conduct$1 to ! ext5t practicable1 9 coord9ation ) inspections conduct$ "u section #cec ( ! ,public ,heal? ,s]vice ,act1 & any ord] result+ f su* r5ewal application %all be treat$ z a te*nology c]tification ord] = purposes ( ?is sub*apt]4 7#d7 ,supplem5ts & reports 7,a7 ,supplem5ts ,except z provid$ 9 subp>agraph 7,b71 any p]son ) a te*nology c]tification ord] 9 effect may seek a supplem5t to su* ord] ^u a *ange or *anges to ! in=mation provid$ 9 ! application = te*nology c]tification "u subp>agraphs 7,c71 7,d71 & 7,e7 ( subsection 7e77#b71 provid$ t-- 7i7 su* p]son is an eligible p]son "u subsection 7b77#a72 & 7ii7 t su* *ange does n exp& ! scope ( ! te*nology c]tification unless ! ,secret>y deems appropriate4 ,a supplem5t may conta9 only in=mation relevant to ! *ange or *anges4 ,! ,secret>y's action on a supplem5t %all be 9 accordance ) subsection 7f71 & any ord] result+ f su* supplem5t %all be treat$ z an am5dm5t to a te*nology c]tification ord] t is 9 effect4 7,b7 ,reports 7i7 ,9 g5]al ,if a *ange describ$ 9 subp>agraph 7,a7 is made 9 ord] to address a pot5tial risk to public heal? by add+ a new specification or te/ me?od1 ! p]son may imm$iately implem5t su* *ange or *anges & %all report su* *anges or *anges to ! ,secret>y )9 #cj days4 7ii7 ,cont5t ,any report to ! ,secret>y "u ?is subp>agraph %all include-- 7,i7 a summ>y ( ! relevant *ange or *anges2 7,,ii7 ! rationale = implem5t+ su* *ange or *anges2 & 7,,iii7 a description ( h[ ! *ange or *anges 7 evaluat$4 7iii7 ,supplem5tal reports ,^u review ( su* report & a f9d+ t ! relevant *ange or *anges are inconsi/5t ) ! /&>d specifi$ "u ?is subp>agraph1 ! ,secret>y may require a supplem5t "u subp>agraph 7,a74 7h7 ,ma9t5ance requirem5ts ,= ! duration ( a te*nology c]tification ord]1 a hold] ( a te*nology c]tification ord] %all-- 7#a7 use ! proc$ures includ$ 9 ! relevant application1 supplem5t1 or report "u subsections 7b7 & 7e72 7#b7 ensure compliance ) any applicable mitigat+ measures2 7#c7 ma9ta91 & provide to ! ,secret>y ^u reque/1 records relat$ to any 9 vitro cl9ical te/ (f]$ )\t prem>ket review "u ! te*nology c]tification ord]1 :]e ^? records are necess>y to demon/rate compliance ) applicable provisions ( ?is sub*apt]2 & 7#d7 comply ) ! notification requirem5ts "u section #ehg;,i = ea* 9 vitro cl9ical te/ (f]$ )\t prem>ket review "u ! te*nology c]tification ord]4 7i7 ,tempor>y hold 7#a7 ,9 g5]al ,^u "o or m f9d+s "u p>agraph 7#d7 & aft] promptly notify+ ! develop] ( su* f9d+s1 ! ,secret>y may issue a tempor>y hold prohibit+ any hold] ( a te*nology c]tification ord] f introduc+ into int]/ate comm]ce an 9 vitro cl9ical te/ t 0 n previ\sly ! subject ( a notification "u section #ehg;,i4 ,! tempor>y hold mu/ id5tify ! gr\nds = ! tempor>y hold "u p>agraph 7#d7 & ! rationale = su* f9d+4 7#b7 ,notification to ! develop] ,! ,secret>y %all n place a tempor>y hold "u ?is subsection unless ! ,secret>y has promptly notifi$ ! develop] ( su* hold & provid$ #cj cal5d> days = ! develop] to come into compliance ) or resolve ! f9d+s "u p>agraph 7#d74 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 ,a tempor>y hold "u ?is subsection may be in/at$ ^u a f9d+ or f9d+s t ! hold] ( a te*nology c]tification ord]-- 7,a7 is n 9 compliance ) any ma9t5ance requirem5ts "u subsection 7h72 7,b7 labels or adv]tises "o or m 9 vitro cl9ical te/s ) false or mislead+ claims2 or 7,c7 is no long] an eligible p]son "u subsection 7b77#a74 7j7 ,)drawal ,! ,secret>y may1 aft] due notice & opportunity = in=mal he>+1 issue an ord] )draw+ a te*nology c]tification ord] if ! ,secret>y f9ds t-- 7#a7 ! application1 supplem5t1 or report "u subsection 7e7 or 7g7 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 = tempor>y hold )9 a timeframe specifi$ 9 ! tempor>y hold ord]4 7k7 ,reports to ,congress 7#a7 ,9 g5]al ,n lat] ?an "o ye> aft] ! effective date1 & annually = #d ye>s !reaft]1 ! ,secret>y %all prep>e & submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate1 & make publicly available1 includ+ ?r\gh po/+ on ! int]net website ( ! ,food & ,drug ,adm9i/ration1 a report conta9+ ! in=mation requir$ "u 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] & type ( applications = te*nology c]tifications fil$1 grant$1 )drawn or d5i$2 7ii7 ! total numb] ( te*nology c]tification ord]s put on tempor>y hold "u subsection 7i7 & ! numb] ( te*nology c]tification ord]s )drawn "u subsection 7j72 7iii7 ! types ( te*nologies = :i* te*nology c]tification ord]s 7 grant$2 & 7iv7 ! total numb] ( laboratories & develop]s ) te*nology c]tification ord]s 9 effect4 7,b7 ,f9al report ,! fif? report submitt$ "u p>agraph 7#a7 %all include a summ>y (1 & responses to1 comm5ts rais$ 9 ! meet+ & docket4 7,c7 ,p]=mance reports ,! reports requir$ "u ?is section may be issu$ z a compon5t ( p]=mance reports z requir$ "u section #i ( ! ,v]ify+ ,accurate ,lead+-edge ,,ivct ,developm5t ,act ( #bjbj4 #ehg;,e4 ,mitigat+ measures 7a7 ,e/abli%m5t ( mitigat+ measures 7#a7 ,e/abli%+1 *ang+1 or )draw+ 7,a7 ,e/abli%m5t ,if ! ,secret>y det]m9es t ! e/abli%m5t ( mitigat+ measures is necess>y = ei!r ( ! reasons describ$ 9 clause 7i7 or 7ii7 ( section #ehg7ae77;,a7 = any 9 vitro cl9ical te/ ) ! same indications = use1 ! ,secret>y may require t ! 9 vitro cl9ical te/ comply ) su* mitigat+ measures4 7,b7 ,process ,not)/&+ sub*apt] ,,ii ( *apt] #e ( title #e1 ,unit$ ,/ates ,code1 ! ,secret>y may-- 7i7 e/abli%1 *ange1 or )draw mitigat+ measures by-- 7,i7 publi%+ a propos$ adm9i/rative ord] 9 ! ,f$]al ,regi/]2 7,,ii7 provid+ an opportunity = public comm5t = a p]iod ( n less ?an #cj cal5d> days2 & 7,,iii7 aft] consid]ation ( any comm5ts submitt$1 publi%+ a f9al adm9i/rative ord] 9 ! ,f$]al ,regi/]2 & 7ii7 may e/abli% mitigat+ measures ) respect to a category 9 a prem>ket approval ord] or te*nology c]tification ord]4 7#b7 ,9 vitro cl9ical te/s previ\sly approv$1 cle>$1 or exempt$ z devices 7,a7 ,9 g5]al ,any special controls or re/rictions applicable to an 9 vitro cl9ical te/ ) ! same indications = use pursuant to section #ehg7aj7 bas$ on prior regulation z a device approv$ "u section #eae1 cle>$ or exempt "u section #eaj7k71 or classifi$ "u section #eac7;f77#b71 includ+ any su* special controls or re/rictions e/abli%$ dur+ ! p]iod beg9n+ on ! date ( enactm5t ( ! ,v]ify+ ,accurate ,lead+-edge ,,ivct ,developm5t ,act ( #bjbj & end+ on ! effective date ( su* ,act 7z describ$ 9 section #e7;b7 ( su* ,act7-- 7i7 %all cont9ue to apply to su* approv$1 cle>$1 or exempt$ 9 vitro cl9ical te/ aft] su* effective date2 & 7ii7 are deem$ to be mitigat+ measures z ( ! effective date ( su* approval1 cle>ance1 or exemption4 7,b7 ,*anges ,! ,secret>y may e/abli%1 *ange1 or )draw mitigat+ measures = su* a te/ or indications = use ! proc$ures "u p>agraph 7#a74 7b7 ,docum5tation 7#a7 ,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-- 7,a7 9 accordance ) section #ehg;,b7c77#b77;,g77i71 submit docum5tation to ! ,secret>y z "p ( ! application = ! te/ "u subsection 7c7 or 7d7 ( section #ehg;,b demon/rat+ t su* mitigat+ measures h be5 met2 7,b7 if su* application is approv$1 ma9ta9 docum5tation demon/rat+ t su* mitigat+ measures cont9ue to be met foll[+ a te/ modification by ! develop]2 & 7,c7 aft] respond+ to any in=mal communications f ! ,secret>y1 make su* docum5tation available to ! ,secret>y ^u reque/ or inspection4 7#b7 ,o!r te/s ,! develop] ( an 9 vitro cl9ical te/ t is m>ket$ )9 ! scope ( 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;,j demon/rat+ t su* mitigat+ measures cont9ue to be met foll[+ a te/ modification by ! develop]2 7,b7 aft] respond+ to any in=mal communications f ! ,secret>y1 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 7c7 ,mitigat+ measures = cross-,ref]5c$ te/s ,n lat] ?an #a ye> aft] ! implem5tation ( ! ,v]ify+ ,accurate ,lead+-edge ,,ivct ,developm5t ,act ( #bjbj1 ! ,secret>y %all issue mitigat+ measures = cross-ref]5c$ te/s4 #ehg;,f4 ,regulatory pa?way r$esignation 7a7 ,te*nology c]tification & exemption det]m9ations 7#a7 ,9 g5]al ,bas$ on new in=mation1 includ+ ! e/abli%m5t ( mitigat+ measures "u section #ehg;,e1 & aft] consid]+ available evid5ce respect+ te/s ) ! same indications = use pursuant to section #ehg7aj71 ! ,secret>y may1 ^u ! initiative ( ! ,secret>y or ^u petition ( an int]e/$ p]son-- 7,a7 revoke any exemption or requirem5t 9 effect "u ?is sub*apt] ) respect to su* indications = use2 or 7,b7 det]m9e t su* indications = use are eligible = te*nology c]tification 9 accordance ) section #ehg;,d7b77#b71 or are o!rwise exempt f prem>ket review "u section #ehg;,b4 7#b7 ,process ,any action "u p>agraph 7#a7 %all be made by publication ( a notice ( su* propos$ action on ! int]net website ( ! ,food & ,drug ,adm9i/ration1 ! consid]ation ( comm5ts to a public docket on su* proposal1 & publication ( a f9al action on su* int]net 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 7b7 ,revocation ,! ,secret>y may revoke any exemption ) respect to su* te/ or indications = use pursuant to section #ehg7aj71 if-- 7#a7 new cl9ical in=mation indicates t ! exemption ( an 9 vitro cl9ical te/ or te/s f prem>ket review "u section #ehg;,b or exemption "u section #ehg;,a has a reasonable probability ( sev]e adv]se heal? consequ5ces1 includ+ ! abs5ce1 delay1 or discont9uation ( appropriate m$ical treatm5t4 7#b7 ,process ,any action "u ?is subsection %all be made by publication ( a notice ( su* propos$ action 9 ! ,f$]al ,regi/]1 consid]ation ( comm5ts to a public docket on su* proposal1 & publication ( a f9al notice 9 ! ,f$]al ,regi/]1 not)/&+ sub*apt] ,,ii ( *apt] #e ( title #e1 ,unit$ ,/ates ,code4 #ehg;,g4 ,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 ( ?is section = ! 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 on ! applicable regulatory pa?way "u section #ehg;,f or risk evaluation = an 9 vitro cl9ical te/ or te/s2 7#c7 quality requirem5ts "u section #ehg;,j or apply+ su* requirem5ts to 9 vitro cl9ical te/s develop$ or import$ by develop]s2 or 7#d7 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 ! developm5t1 manufacture1 or utilization ( 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 9 ! 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 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;,h4 ,reque/ = in=mal fe$back ,be=e submitt+ a prem>ket application or te*nology c]tification application = an 9 vitro cl9ical te/-- 7#a7 ! develop] ( ! te/ may submit to ! ,secret>y a writt5 reque/ = a meet+ or conf]5ce to discuss & provide in=mation relat+ to ! regulation ( su* 9 vitro cl9ical te/ :i* may include-- 7,a7 ! submission process & ! type & am\nt ( evid5ce expect$ 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 )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 & 7,b7 )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]5ce4 #ehg;,i4 ,regi/ration & li/+ 7a7 ,regi/ration ( ,e/abli%m5ts = ,9 ,vitro ,cl9ical ,te/s 7#a7 ,9 g5]al ,ea* p]son describ$ 9 subsection 7b77#a71 or an accr$it$ p]son "u section #ehg,p1 act+ on behalf ( su* a p]son1 %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 n lat] ?an-- 7i7 ! date ( implem5tation ( ?is section if su* e/abli%m5t is engag$ 9 any activity describ$ 9 subsection 7b77#a7 on ! date ( enactm5t ( ?is section1 unless ! ,secret>y e/abli%es by guidance a date lat] ?an su* implem5tation date = all or a category ( su* e/abli%m5ts2 or 7ii7 #cj days prior to engag+ 9 any activity describ$ 9 subsection 7b77#a7 aft] enactm5t ( ?is section1 if su* e/abli%m5t is n engag$ 9 any activity describ$ 9 ?is p>agraph on ! date ( enactm5t ( ?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 ! int]net website ma9ta9$ by ! ,food & ,drug ,adm9i/ration1 9 accordance ) subsection 7d74 7#c7 ,inspection ,e 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]1 a contract manufactur] 7includ+ contract packag+71 contract /]iliz]1 repackag]1 relabel]1 or di/ributor ( an 9 vitro cl9ical te/2 & 7,b7 introduces or proposes to beg9 ! introduction or deliv]y = introduction into int]/ate comm]ce ?r\gh an exemption "u section #ehg;,a7f77#b77;b7 or #ehg;,a7g7 or ?r\gh ! fil+ ( an application "u section #ehg;,b or #ehg;,d1 %all submit a li/+ to ! ,secret>y conta9+ ! in=mation describ$ 9 p>agraph 7#b7 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 "u section #ehg,t ! foll[+ in=mation = ea* 9 vitro cl9ical te/ = :i* su* p]son is a develop] 9 ! =m & mann] prescrib$ by ! ,secret>y3 7,a7 ,"n ( ! e/abli%m5t & its facility 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 ,,clia c]tificate numb] = any laboratory c]tifi$ by ! ,secret>y "u section #bfc;a ( title #db t meets ! requirem5ts = p]=m+ high-complexity te/+ t is ! develop] ( ! 9 vitro cl9ical te/1 & ,,clia c]tificate numb] = any laboratory "u common own]%ip t is p]=m+ ! te/ develop$ by su* te/ develop]4 7,e7 ,:e!r ! 9 vitro cl9ical te/ is1 z applicable1 (f]$ z a te/ approv$ "u section #ehg;,b1 (f]$ "u a te*nology c]tification ord] issu$ "u section #ehg;,d1 or (f]$ z an 9 vitro cl9ical te/ "u section #ehg;,a4 7,f7 ,indications = use in=mation "u section #ehg7aj74 7,g7 ,brief n>rative description ( ! 9 vitro cl9ical te/4 7,h7 ,a brief summ>y ( ! analytical & cl9ical p]=mance ( ! 9 vitro cl9ical te/1 & z applicable1 ! lot release crit]ia4 7,i7 ,a brief description ( con=mance ) any applicable mitigat+ measures1 re/rictions1 & /&>ds4 7,j7 ,repres5tative label+ = ! 9 vitro cl9ical te/1 z appropriate4 7,k7 ,a /atem5t t ! in=mation submitt$ is tru?ful & accurate4 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 ,abbreviat$ li/+ ,a p]son :o is n a develop] b is o!rwise requir$ to regi/] pursuant to subsection 7a7 %all submit an abbreviat$ li/+ to ! ,secret>y conta9+ ! in=mation describ$ 9 subp>agraphs 7,a7 ?r\gh 7,c7 ( p>agraph 7#b71 & ! "n ( ! develop]4 ,! in=mation %all be submitt$ 9 accordance ) ! applicable s*$ule describ$ "u subsection 7c74 ,su* abbreviat$ li/+ %all be prep>$ 9 su* =m & mann] z ! ,secret>y may specify 9 guidance4 ,li/+ in=mation %all be submitt$ to ! compreh5sive te/ in=mation sy/em 9 accordance ) section #ehg,t1 z appropriate4 7#e7 ,gr&fa!r$ te/s ,a develop] ( an 9 vitro cl9ical te/ develop] (f]+ a te/ t is gr&fa!r$ "u section #ehg;,a7c7 %all submit li/+ in=mation requir$ "u subp>agraphs 7,a7 ?r\gh 7,i7 ( p>agraph 7#b74 7#f7 ,l[-risk te/s ,a develop] ( a l[ risk 9 vitro cl9ical te/ %all notify & submit li/+ in=mation to ! ,secret>y )9 "o ye> ( (f]+ su* te/ = cl9ical use4 7#g7 ,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 pursuant to an exemption "u section #ehg;,a may submit li/+ in=mation "u ?is subsection4 7c7 ,timel9es = ,submission 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 ! date ( enactm5t ( ?is section1 a p]son %all ma9ta9 a device li/+ "u section #eaj until su* "t z ! sy/em = submitt+ ! notification in=mation requir$ "u subsection 7b7 becomes available & !reaft] %all submit ! notification in=mation no lat] ?an #a ye> aft] ! sy/em = submitt+ ! notification "u ?is section becomes available4 7,b7 ,= an 9 vitro cl9ical te/ t is subject to ! gr&fa!r+ provisions ( section #ehg;,a7c71 a p]son %all submit ! li/+ in=mation requir$ "u subsection 7b77#e7 no lat] ?an #a ye> aft] ! sy/em = submitt+ ! notification "u ?is section becomes available4 7,c7 ,= an 9 vitro cl9ical te/ t is n subject to subp>agraph 7,a7 or 7,b71 a p]son %all submit ! requir$ notification in=mation prior to (f]+1 introduc+1 or m>ket+ ! 9 vitro cl9ical te/ 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=mation no lat] ?an #cj bus9ess days aft] ! date ( approval ( ! prem>ket approval application4 7ii7 ,= a develop] :o has receiv$ a te*nology c]tification ord] "u section #ehg;,d1 a p]son %all submit ! requir$ li/+ in=mation at lea/ #cj bus9ess days aft] receiv+ su* te*nology c]tification ord]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 notifi$ 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> z a compon5t ( ! annual report submitt$ "u sections #ehg;,b & #ehg;,d4 7d7 ,public ,availability ( ,notification ,in=mation 7#a7 ,9 g5]al ,notification 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 ,notification in=mation = an 9 vitro cl9ical te/ t is subject to prem>ket approval or te*nical 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]4 7#c7 ,exceptions f public availability requirem5ts ,! regi/ration & li/+ in=mation requirem5ts describ$ 9 subsections 7a7 & 7b7 %all n apply to ! ext5t ! ,secret>y det]m9es t su* in=mation relates to-- 7,a7 trade secret or comm]cial confid5tial in=mation2 or 7,b7 national security or c\nt]measures or is re/rict$ f disclosure pursuant to ano!r provision ( law4 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 an accr$it$ p]son "u section #ehg,p4 #ehg;,j4 ,te/ design & quality requirem5ts 7a7 ,applicability 7#a7 ,9 g5]al ,ea* develop] & ea* o!r p]son requir$ to regi/] "u section #ehg;,i7b77#a7 %all e/abli% & ma9ta9 quality requirem5ts 9 accordance ) ! applicable requirem5ts set =? 9 subsection 7b71 except z provid$ 9 section #ehg;,a4 7#b7 ,c]tifi$ laboratory requirem5ts ,a develop] t op]ates a cl9ical laboratory c]tifi$ by ! ,secret>y "u section #cec ( ! ,public ,heal? ,s]vice ,act t-- 7,a7 meets ! requirem5ts = p]=m+ high-complexity te/+2 7,b7 7i7 develops an vitro cl9ical te/ or indications = use2 or 7ii7 modifies ano!r develop]'s 9 vitro cl9ical te/ 9 t c]tifi$ laboratory 9 a mann] describ$ 9 section #ehg7f72 & 7,c7 develops an 9 vitro cl9ical te/ or indications = use t are = use only )9 t c]tifi$ laboratory or )9 ano!r c]tifi$ laboratory ) common own]%ip1 %all e/abli% & ma9ta9 quality requirem5ts t comply ) ! requirem5ts set =? 9 subsection 7b77#b74 7#c7 ,applicability = c]ta9 9 vitro cl9ical te/s ,! applicable requirem5ts set =? 9 subsection 7b77#a7 %all apply to any in/rum5t1 specim5 receptacle1 or compon5t or "p t is develop$ = use by a cl9ical laboratory to :i* p>agraph 7#b7 applies4 7#d7 ,regulations ,! ,secret>y may promulgate regulations to implem5t ?is section4 ,9 s promulgat+ regulations1 ! ,secret>y %all consid] :e!r & to :at ext5t int]national h>monization is appropriate4 7b7 ,quality requirem5ts 7#a7 ,quality requirem5ts = laboratories )\t ,,clia c]tification to conduct high-complexity te/s ,! quality requirem5ts applicable "u ?is section %all-- 7,a7 avoid duplication ( regulations "u section #cec ( ! ,public ,heal? ,s]vice ,act2 7,b7 apply only to ! developm5t1 validation1 production1 prep>ation1 propagation1 or assembly relat$ to ! design & associat$ manufacture & di/ribution ( an 9 vitro cl9ical te/ (f]$ "u ?is sub*apt]2 7,c7 n apply ) respect to laboratory op]ations2 & 7,d7 %all include ! foll[+1 subject to p>agraphs 7#b7 & 7#c7-- 7i7 managem5t responsibility2 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+ product2 7xi7 corrective & prev5tive action2 7xii7 label+ & packag+ controls2 7xiii7 h&l+1 /orage1 di/ribution1 & in/allation2 7xiv7 records2 7xv7 s]vic+2 & 7xvi7 /ati/ical te*niques4 7#b7 ,quality requirem5ts = laboratories c]tifi$ to conduct high-complexity te/s ,quality requirem5ts applicable to ! 9 vitro cl9ical te/s & develop]s describ$ 9 subsection 7a77#b7 %all-- 7,a7 avoid duplication ( regulations "u section #cec ( ! ,public ,heal? ,s]vice ,act2 & 7,b7 consi/ (1 z direct$ relat$ to ! design & developm5t-- 7i7 design controls2 7ii7 pur*as+ controls2 7iii7 acceptance activities2 7iv7 corrective & prev5tative action2 & 7v7 records4 7#c7 ,quality requirem5ts = c]ta9 laboratories di/ribut+ 9 vitro cl9ical te/s or te/ protocols )9 organizations or public heal? networks 7,a7 ,9 g5]al ,quality requirem5ts applicable to ! develop] :o is di/ribut+ 9 vitro cl9ical te/ di/ribut$ z describ$ 9 subp>agraph 7,b7 %all consi/ ( ! foll[+3 7i7 ,! requirem5ts 9 p>agraph 7#b74 7ii7 ,! label+ requirem5ts 9 p>agraph 7#a77;,c77xii74 7iii7 ,! requirem5t to ma9ta9 records ( ! laboratories to :i* ! 9 vitro cl9ical te/ or te/ protocol is di/ribut$4 7,b7 ,di/ribut+ laboratory ,subp>agraph 7,a7 %all apply to develop]s t meet ! foll[+ conditions3 7i7 ,! laboratory di/ribut+ ! te/ protocol is c]tifi$ by ! ,secret>y "u section #cec ( ! ,public ,heal? ,s]vice ,act & meets ! requirem5ts = p]=m+ high-complexity te/+4 7ii7 ,! laboratory develops its own 9 vitro cl9ical te/ or modifies ano!r develop]'s 9 vitro cl9ical te/ 9 a mann] describ$ 9 section #ehg7f74 7iii7 ,! laboratory di/ributes ! 9 vitro cl9ical te/ or te/ protocol = su* te/ only to ano!r laboratory t-- 7,i7 is c]tifi$ by ! ,secret>y "u section #cec ( ! ,public ,heal? ,s]vice ,act & meets ! requirem5ts = p]=m+ high-complexity te/+2 7,,ii7 is )9 ! same corporate organization & hav+ common own]%ip by ! same p>5t corporation2 or z applicable1 is a laboratory )9 a public heal? laboratory network coord9at$ or manag$ by ! ,c5t]s = ,disease ,control & ,prev5tion2 & 7,,iii7 implem5ts ! te/ protocol )\t fur!r modification4 7c7 ,regulations ,9 implem5t+ quality requirem5ts = te/ develop]s "u ?is section1 ! ,secret>y %all-- 7#a7 = purposes ( facilitat+ int]national h>monization1 consid] :e!r ! develop] p>ticipates 9 an audit program 9 :i* ! ,unit$ ,/ates p>ticipates or ! ,unit$ ,/ates recognizes or con=ms ) /&>ds recogniz$ by ! ,secret>y2 & 7#b7 ensure a lea/ burd5some approa* describ$ 9 section #ehg;,b7j7 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,k4 ,label+ requirem5ts 7a7 ,9 ,g5]al ,an 9 vitro cl9ical te/ %all be> or be accompani$ by label+1 & a label z applicable1 t meet ! requirem5ts set =? 9 subsections 7b7 & 7c71 unless su* te/ is exempt z specifi$ 9 subsection 7d7 or 7e74 7b7 ,labels 7#a7 ,9 g5]al ,! label ( an 9 vitro cl9ical te/ %all meet ! requirem5ts set =? 9 p>agraph 7#b71 except ?is requirem5t %all n apply to an 9 vitro cl9ical te/ t-- 7,a7 consi/s solely ( a te/ protocol2 or 7,b7 is develop$1 manufactur$1 & us$ solely )9 a s+le laboratory c]tifi$ by ! ,secret>y "u section #cec ( ! ,public ,heal? ,s]vice ,act t meets ! requirem5ts = p]=m+ high-complexity te/+4 7#b7 ,regulations ,! label ( an 9 vitro cl9ical te/ %all /ate ! "n & place ( bus9ess ( its develop] & meet ! requirem5ts set =? 9 regulations promulgat$ "u ?is section4 7c7 ,label+ 7#a7 ,9 g5]al ,label+ accompany+ an 9 vitro cl9ical te/1 includ+ label+ 9 ! =m ( a package ins]t1 /&alone laboratory ref]5ce docum5t1 or o!r simil> docum5t except ! label+ specifi$ 9 p>agraph 7#b71 %all include adequate directions = use & %all meet ! requirem5ts set =? 9 regulations promulgat$ "u ?is section1 except z provid$ 9 subsection 7d7 or 7e74 ,label+ 9 ! =m ( a package ins]t %all also include ! in=mation 9 subp>agraph 7,a7 or 7,b7 ( p>agraph 7#b74 7#b7 ,cont5t 7,a7 ,9 g5]al ,label+ accompany+ an 9 vitro cl9ical te/ t is 9 ! =m ( a te/ report template or ord]+ in=mation %all include-- 7i7 ! te/ li/+ numb] t 0 provid$ to ! develop] at ! "t ( li/+2 7ii7 in/ructions = h[ & :]e to report an adv]se ev5t "u section #ehg,l2 7iii7 in/ructions = h[ & :]e to access ! p]=mance summ>y data display$ 9 ! li/+ database = ! te/2 7iv7 ! int5d$ use ( ! 9 vitro cl9ical te/2 & 7v7 any w>n+s1 contra9dications1 or limitations4 7,b7 ,public availability ( in=mation ,! ,secret>y %all make all ( ! in=mation describ$ 9 subp>agraph 7,a7 ) 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 is-- 7i7 trade secret or comm]cial confid5tial in=mation2 or 7ii7 national security or c\nt]measures or is re/rict$ f disclosure pursuant to ano!r provision ( law4 7#c7 ,additional requirem5ts ,label+ = an 9 vitro cl9ical te/ us$ = immunohematology te/+ %all meet ! foll[+ applicable requirem5ts set =? 9 "p #ffj ( ! ,code ( ,f$]al ,regulations 7or any successor regulation71 relat$ 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 #ba ( ! ,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 design$ & manufactur$ by a laboratory c]tifi$ by ! ,secret>y "u section #cec ( ! ,public ,heal? ,s]vice ,act t meets ! requirem5ts = p]=m+ high-complexity te/+2 & 7ii7 p]=m$ 9 ! same laboratory 9 :i* x 0 develop$ or by ano!r su* laboratory c]tifi$ by ! ,secret>y "u section #cec ( ! ,public ,heal? ,s]vice ,act t meets ! requirem5ts = p]=m+ high complexity te/+ & is "u common own]%ip ) ! laboratory t design$ & manufactur$ ! te/4 7#b7 ,te/ in/rum5t label+ ,! 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 #ba ( ! ,code ( ,f$]al ,regulations1 z x appe>s on ! date ( enactm5t ( ?is sub*apt] & am5d$ !reaft]4 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 ! sy/em4 7#d7 ,lab ,rese>* or ,inve/igational ,use ,a %ipm5t or o!r deliv]y ( an 9 vitro cl9ical te/ = rese>* or inve/igational use pursuant to section #ehg;,a7m7 %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 7b7 & subsection 7c77#a74 7#f7 ,analyte ,specific ,reag5ts ,! label+ = analyte specific reag5ts %all be> ! foll[+ /atem5t3 ,?is product is int5d$ solely = fur!r developm5t ( an 9 vitro cl9ical te/ & is exempt f mo/ ,,fda regulation4 ,?is product mu/ be evaluat$ by ! 9 vitro cl9ical te/ develop] 9 accordance ) applicable requirem5ts44 ,if ! label+ ( an analyte specific reag5t be>s ! in=mation set =? 9 ?is p>agraph1 x ne$ n be> ! in=mation requir$ by subsection 7c77#a74 7#g7 ,ov]-!-c\nt] te/ sample collection sy/ems label+ ,! label+ = ov]-!-c\nt] te/ sample collection sy/ems = drugs ( abuse te/+ %all be> ! "n & place ( bus9ess ( ! develop] includ$ 9 ! regi/ration li/+ "u section #ehg;,i1 9 language appropriate = ! int5d$ us]s4 ,if ! label+ ( su* ov]-!-c\nt] te/ sample collection sy/em be>s ! in=mation set =? 9 ?is p>agraph 7#d77;,g71 x ne$ n be> ! in=mation requir$ by subsection 7c77#a74 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 section1 = 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 ! safety1 effectiv5ess1 or availability ( su* products t are or w be includ$ 9 ! ,/rategic ,national ,/ockpile4 7#b7 ,regulations ,! ,secret>y may issue regulations am5d+ section #hji4aa ( title #ba ( ! ,code ( ,f$]al ,regulations or any successor regulation to apply 9 full or 9 "p to 9 vitro cl9ical te/s & 9 vitro cl9ical te/ develop]s4 7f7 ,guidance ,! ,secret>y may1 9 collaboration ) develop]s1 issue guidance on /&>diz$1 g5]al cont5t & =mat = 9 vitro cl9ical te/ label+ to help ensure compliance ) applicable requirem5ts 9 ?is subsection4 #ehg,l4 ,adv]se ev5t report+ 7a7 ,applicability 7#a7 ,9 g5]al ,ea* 9 vitro cl9ical te/ develop] %all e/abli% & ma9ta9 a sy/em = report+ adv]se ev5ts 9 accordance ) subsection 7b71 except z provid$ 9 section #ehg;,a4 7#b7 ,regulations ,! ,secret>y %all promulgate regulations to implem5t ?is section1 includ+ in=mation necess>y to be report$ to ensure ! analytical & cl9ical validity ( 9 vitro cl9ical te/s1 & ! safety ( articles = tak+ or d]iv+ specim5s f ! human body4 7b7 ,adv]se ,ev5t ,report+ ,requirem5ts ,ea* develop] %all report to ! ,secret>y :5ev] in=mation t reasonably sugge/s t "o ( ! develop]'s 9 vitro cl9ical te/s is associat$ ) an adv]se ev5t becomes kn[n to ! develop]4 7c7 ,reports ,reports requir$ "u ?is section %all be submitt$ z foll[s3 7#a7 ,an individual adv]se ev5t report %all be submitt$ = ! foll[+ ev5ts n lat] ?an-- 7,a7 #e cal5d> days aft] an 9 vitro cl9ical te/ develop] receives or o!rwise becomes aw>e ( in=mation t reasonably sugge/s ! adv]se ev5t involves a pati5t dea?2 or 7,b7 #e cal5d> days aft] an 9 vitro cl9ical te/ develop] receives or o!rwise becomes aw>e ( in=mation t reasonably sugge/s ! ev5t pres5ts an imm95t ?reat to public heal?4 7#b7 ,qu>t]ly reports %all be submitt$ = all o!r adv]se ev5ts1 if any1 & no lat] ?an ! end ( ! qu>t] foll[+ ! qu>t] 9 :i* ! adv]se ev5t in=mation 0 receiv$ by ! 9 vitro cl9ical te/ develop]4 7d7 ,def9itions ,9 ?is section-- 7#a7 ! t]m adv]se ev5t-- 7,a7 means-- 7i7 dea? (1 or s]i\s injury to1 a specific pati5t or us] = :i* x is reasonably believ$ t an 9 vitro cl9ical te/ error contribut$ to su* dea? or s]i\s injury2 or 7ii7 an 9 vitro cl9ical te/ error t may h reasonable likelihood to cause s]i\s injury or dea?2 & 7,b7 excludes laboratory errors t are subject to ! requirem5ts ( section #cec ( ! ,public ,heal? ,s]vice ,act & corrective or prev5tive actions to prev5t su* errors2 7#b7 ! t]m 9 vitro cl9ical te/ error-- 7,a7 means a failure 9 an 9 vitro cl9ical te/ to meet ! analytical or cl9ical validity /&>d or o!rwise p]=m z int5d$ by ! develop]2 & 7,b7 includes an inaccurate false result t rea*es a heal? c>e provid]1 pati5t1 or consum]1 except t su* t]m excludes any su* ev5t or error relat$ to laboratory op]ations pursuant to section #cec ( ! ,public ,heal? ,s]vice ,act2 & 7#c7 ! t]m s]i\s injury means-- 7,a7 a significant delay 9 a critical diagnosis or caus+ ! abs5ce1 delay1 or discont9uation ( critical m$ical treatm5t or t irrev]sibly or s]i\sly & negatively alt]s ! c\rse ( ! disease or condition2 or 7,b7 an injury t-- 7i7 is life ?reat5+2 7ii7 results 9 p]man5t impairm5t ( a body function or p]man5t damage to a body /ructure2 or 7iii7 necessitates m$ical or surgical int]v5tion to preclude p]man5t impairm5t ( a body function or p]man5t damage to a body /ructure4 #ehg,m4 ,corrections & removals 7a7 ,9 g5]al ,! ,secret>y %all promulgate regulations to implem5t ?is section1 includ+ in=mation necess>y to be report$ to ensure ! analytical & cl9ical validity ( 9 vitro cl9ical te/s1 & ! safety ( specim5 receptacles4 7b7 ,reports ( removals & corrections 7#a7 ,9 g5]al ,ea* 9 vitro cl9ical te/ develop] or import] %all report to ! ,secret>y any correction or removal ( an 9 vitro cl9ical te/ und]tak5 by su* develop] or import] if ! removal or correction 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 ,no report ( ! correction or removal ( an 9 vitro cl9ical te/ is requir$ "u p>agraph 7#a7 if a report ( ! correction or removal is requir$ "u1 & has be5 submitt$ "u1 section #ehg,l4 7c7 ,tim+ ,a develop] or import] %all submit any report requir$ "u ?is subsection to ! ,secret>y )9 #ae bus9ess days ( initiat+ su* correction or removal4 7d7 ,recordkeep+ ,a develop] or import] ( an 9 vitro cl9ical te/ :o 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 ! volunt>y report+ ( a correction or removal by ! develop]-- 7#a7 ! ,secret>y %all classify su* correction or removal "u ?is section )9 #ae cal5d> days2 & 7#b7 n lat] ?an #de 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 7f7 ,limitation ,! develop] is n requir$ to report a correction or removal ( an 9 vitro cl9ical te/ bas$ solely on an adv]se ev5t report "u section #ehg,l t captures an error )9 ! approv$ p]=mance /&>ds = su* te/4 7g7 ,def9itions ,= purposes ( ?is section-- 7#a7 ! t]m correction means ! repair1 modification1 adju/m5t1 relabel+1 de/ruction1 or inspection 7includ+ pati5t monitor+7 ( an 9 vitro cl9ical te/ )\t its physical removal f its po9t ( use to ano!r location1 & does n include r\t9e s]vic+2 & 7#b7 ! t]m removal means ! physical removal ( an 9 vitro cl9ical te/ f its po9t ( use to ano!r location = repair1 modification1 adju/m5t1 relabel+1 de/ruction1 or inspection1 & does n include r\t9e s]vic+4 #ehg,n4 ,re/rict$ 9 vitro cl9ical te/s 7a7 ,applicability 7#a7 ,9 g5]al ,! ,secret>y1 9 issu+ an approval ( an 9 vitro cl9ical te/ "u section #ehg;,b ( a category describ$ 9 p>agraph 7#c7 may require t su* te/ 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 prescrib$ by ! secret>y ,! conditions prescrib$ by ! ,secret>y "u ?is p>agraph1 ) respect to an 9 vitro cl9ical te/ describ$ 9 p>agraph 7#c71 are ^? conditions :i* ! ,secret>y det]m9es due to ! pot5tiality = h>mful effect ( su* te/ 7includ+ any result+ abs5ce1 delay1 or discont9uation ( appropriate m$ical treatm5t71 are necess>y to assure ! analytical or cl9ical validity ( ! te/1 or ! safety ( a specim5 receptacle4 7#c7 ,9 vitro cl9ical te/s subject to re/rictions ,! re/rictions au?oriz$ "u ?is section may be appli$ by ! ,secret>y to any high-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/ ,! label1 label+1 & 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 ! approval1 provisional approval1 te*nology c]tification1 or regulation1 z applicable4 7c7 ,requirem5ts prior to enactm5t ,an 9 vitro cl9ical te/ t 0 (f]$1 sold1 or di/ribut$ z a re/rict$ device prior to ! enactm5t date ( ?is sub*apt] %all cont9ue to comply ) ! applicable re/rictions impos$ "u section #eae or section #ebj7;e7 until ! effective date ( re/rictions issu$ "u subsection 7a74 #ehg,o4 ,appeals 7a7 ,significant decision 7#a7 ,9 g5]al ,! ,secret>y %all provide a sub/antive summ>y ( ! sci5tific & regulatory rationale = any significant decision ( ! ,c5t] = ,devices & ,radiological ,heal? reg>d+ submission ( an application =1 or a review (1 an 9 vitro cl9ical te/ "u section #ehg;,b or section #ehg;,d or reg>d+ an exemption "u section #ehg;,a1 includ+ 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;,b7j71 z applicable4 7b7 ,review ( significant decisions 7#a7 ,reque/ = sup]visory review ( significant decision ,any p]son 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 p]son 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* p]son 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/$1 n lat] ?an #cj days aft] su* reque/ is made4 ,! ,secret>y %all issue a decision to ! p]son reque/+ a review "u ?is subsection n lat] ?an #de days aft] ! reque/ is made "u p>agraph 7#a71 or1 9 ! case ( a p]son :o reque/s an 9-p]son meet+ or teleconf]5ce1 #cj days aft] su* meet+ or teleconf]5ce4 7c7 ,advisory panels ,! process e/abli%$ "u subsection 7a7 %all p]mit ! appellant to reque/ review by an advisory committee e/abli%$ "u section #eac or #ehg;,g4 ,! ,secret>y %all provide a response to an appellant "u ?is subsection n lat] ?an #de days aft] ! reque/$ advisory committee is conv5$4 #ehg,p4 ,accr$it$ p]sons 7a7 ,9 ,g5]al 7#a7 ,review ( ,applications 7,a7 ,accr$itation = application review ,subject to subp>agraph 7,c71 dur+ ! p]iod beg9n+ on ! date ( enactm5t ( ! ,v]ify+ ,accurate ,lead+-edge ,,ivct ,developm5t ,act ( #bjbj & end+ #b ye>s aft] ! date ( enactm5t ( su* ,act1 ! ,secret>y %all accr$it p]sons = any ( ! foll[+ purposes3 7i7 ,review+ applications = prem>ket approval "u section #ehg;,b & applications = te*nology c]tification "u section #ehg;,d4 7ii7 ,mak+ recomm5dations to ! ,secret>y ) respect to an approval ( an application "u section #ehg;,b or issuance ( a te*nology c]tification ord] "u section #ehg;,d4 7,b7 ,requirem5t reg>d+ review recomm5dations 7i7 ,9 g5]al ,9 mak+ a recomm5dation to ! ,secret>y "u ?is section1 an accr$it$ p]son %all notify ! ,secret>y 9 writ+ ( ! reasons = ! recomm5dation conc]n+ ! application4 7ii7 ,"t p]iod = review ,n lat] ?an #cj cal5d> days aft] ! date on :i* ! ,secret>y is notifi$ ( a recomm5dation "u ?is section ) respect to an application = prem>ket approval or te*nology c]tification1 ! ,secret>y %all make a det]m9ation ) respect to ! application4 7,c7 ,lack ( applications )9 #b-ye> timeframe ,if ! ,secret>y does n receive applications f p]sons t meet ! crit]ia "u subsection 7c7 )9 su* p]iod1 ! ,secret>y-- 7i7 may accr$it p]sons "u ?is p>agraph aft] ! #b-ye> p]iod describ$ 9 subp>agraph 7,a72 & 7ii7 %all issue a public notice on ! int]net website ( ! ,food & ,drug ,adm9i/ration call+ = applications = su* accr$itation4 7#b7 ,inspections 7,a7 ,accr$itation = inspections ,subject to subp>agraph 7,b71 dur+ ! p]iod beg9n+ on ! date ( enactm5t ( ! ,v]ify+ ,accurate ,lead+-edge ,,ivct ,developm5t ,act ( #bjbj & end+ #b ye>s aft] ! date ( enactm5t ( su* ,act1 ! ,secret>y %all accr$it p]sons = ! purpose ( conduct+ inspections ( 9 vitro cl9ical te/ develop]s & o!r p]sons requir$ to regi/] pursuant to section #ehg;,i4 7,b7 ,lack ( applications )9 #b-ye> timeframe ,if no p]sons :o meet ! crit]ia = su* accr$itation apply dur+ ! #b-ye> p]iod describ$ 9 subp>agraph 7,a71 ! ,secret>y-- 7i7 may accr$it p]sons "u ?is subp>agraph aft] su* p]iod2 & 7ii7 %all issue a public notice on ! int]net website ( ! ,food & ,drug ,adm9i/ration call+ = applications = su* accr$itation4 7,c7 ,effect ( accr$itation 7i7 ,9 g5]al ,p]sons accr$it$ "u subp>agraph 7,a7 to conduct inspections1 :5 conduct+ su* inspections1 %all record 9 writ+ _! specific obs]vations & %all pres5t _! obs]vations to ! designat$ repres5tative ( ! inspect$ e/abli%m5t4 7ii7 ,inspection report requirem5ts ,ea* p]son accr$it$ "u ?is p>agraph %all prep>e & submit to ! ,secret>y an inspection report 9 a =m & mann] designat$ by ! ,secret>y = conduct+ inspections1 tak+ into consid]ation ! goals ( int]national h>monization ( quality sy/ems /&>ds4 ,any (ficial classification ( ! inspection %all be det]m9$ by ! ,secret>y4 ,any /atem5t or repres5tation made by an employee or ag5t ( an e/abli%m5t to a p]son accr$it$ to conduct inspections %all be subject to section #ajja ( title #ah1 ,unit$ ,/ates ,code4 7,d7 ,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;,i4 7,e7 ,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-- 7i7 = r\t9e surveillance activities associat$ ) applications "u sections #ehg;,b & #ehg;,d2 or 7ii7 to meet ! requirem5ts to receive prem>ket approval "u section #ehg;,b or a te*nology c]tification ord] "u section #ehg;,d1 z applicable4 7b7 ,accr$itation 7#a7 ,accr$itation ,program 7,a7 ,9 g5]al ,! ,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 ( bo? applications submitt$ "u sections #ehg;,b & #ehg;,d z describ$ 9 subsection 7a77#a77;,a7 & to conduct inspection activities "u subsection 7a77#b77;,a71 or = a subset ( su* review or activities4 7,b7 ,eligible p]sons ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,v]ify+ ,accurate ,lead+-edge ,,ivct ,developm5t ,act ( #bjbj1 ! ,secret>y %all issue draft guidance on ! crit]ia t ! ,secret>y w use to accr$it or d5y accr$itation to a p]son :o reque/s su* accr$itation "u subsection 7a71 & n lat] ?an "o ye> aft] ! close ( ! comm5t p]iod = ! draft guidance issu$ 9 ?is section1 issue f9al guidance4 7,c7 ,requirem5ts 7i7 ,9 g5]al ,! ,secret>y %all n accr$it or ma9ta9 accr$itation = a p]son unless su* p]son meets ! m9imum qualifications requir$ "u subsection 7c74 7ii7 ,scope ( accr$itation ,! accr$itation ( a p]son "u ?is section %all specify ! p>ticul> activities "u subsection 7a7 = :i* su* p]son is accr$it$4 7,d7 ,public li/ ,! ,secret>y %all publi% on ! int]net website ( ! ,food & ,drug ,adm9i/ration a li/ ( p]sons :o are accr$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$4 7#b7 ,accr$itation ,process 7,a7 ,accr$itation process guidance ,! ,secret>y %all-- 7i7 n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,v]ify+ ,accurate ,lead+-edge ,,ivct ,developm5t ,act ( #bjbj1 issue draft guidance specify+ ! process = submitt+ a reque/ = ea* type ( accr$itation & reaccr$itation "u ?is section1 includ+ ! =m & cont5t ( in=mation to be submitt$ 9 su* a reque/2 & 7ii7 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$1 & %all include any limitation to c]ta9 eligible 9 vitro cl9ical te/s4 7,d7 ,audit ,! ,secret>y may audit ! p]=mance ( p]sons accr$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$itation4 7,e7 ,susp5sion or )drawal ,! ,secret>y may susp5d or )draw accr$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$itation1 or poses a ?reat to public heal?1 or fails to act 9 a mann] t is consi/5t ) ! purposes ( ?is section4 7,f7 ,reaccr$itation ,accr$it$ p]sons may be initially accr$it$ = up to #d ye>s4 ,aft] expiration ( su* initial p]iod1 p]sons may be reaccr$it$ = unlimit$ additional #d-ye> p]iods1 z det]m9$ by ! ,secret>y4 7c7 ,qualifications ( accr$it$ ,p]sons 7#a7 ,eligibility ,an accr$it$ p]son1 at a m9imum1 %all-- 7,a7 n be an employee ( ! ,f$]al ,gov]nm5t2 7,b7 n engage 9 ! activities ( a develop]1 z def9$ 9 section #ehg7g72 7,c7 n be a p]son requir$ to regi/] "u section #ehg;,i1 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 7,d7 n be own$ or controll$ by1 & %all h no organizational1 mat]ial or f9ancial affiliation )1 an 9 vitro cl9ical te/ develop] or o!r p]son requir$ to regi/] "u section #ehg;,i2 7,e7 be a legally con/itut$ entity p]mitt$ to conduct ! activities = :i* x seeks accr$itation2 7,f7 ensure t ! op]ations ( su* p]son are 9 accordance ) g5]ally accept$ pr(essional & e?ical bus9ess practices2 & 7,g7 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-- 7i7 c]tify t ! in=mation report$ to ! ,secret>y accurately reflects ! data or protocol review$1 & ! docum5t$ inspection f9d+s1 z applicable2 7ii7 limit "w to t = :i* compet5ce & capacity are available2 7iii7 treat in=mation receiv$ or le>n$1 records1 reports1 & recomm5dations z propriet>y in=mation ( ! p]son submitt+ su* in=mation2 & 7iv7 9 conduct+ ! activities = :i* ! p]son is accr$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 subp>agraph 7,a71 7,b71 7,c71 or 7,d7 ( p>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 7d7 ,comp5sation ( ,accr$it$ ,p]sons 7#a7 ,9 g5]al ,comp5sation ( an accr$it$ p]son :o reviews an application = prem>ket approval submitt$ "u section #ehg;,b or an application = te*nical c]tification submitt$ "u section #ehg;,d %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 7#b7 ,inspection accr$itation ,comp5sation ( an accr$it$ p]son :o is conduct+ an inspection "u section #gjd %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 7e7 ,coop]ative ,agreem5ts ,! ,secret>y is au?oriz$ to ent] into coop]ative arrangem5ts ) (ficials ( =eign c\ntries to ensure t adequate & effective means are available = purposes ( det]m9+1 f "t to "t1 :e!r 9 vitro cl9ical te/s int5d$ = use 9 ! ,unit$ ,/ates by a p]son ^: facility is locat$ outside ! ,unit$ ,/ates %all be refus$ admission on any ( ! gr\nds set =? 9 section #hja7;a74 7f7 ,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;,i4 #ehg,q4 ,recogniz$ /&>ds 7a7 ,9 g5]al ,! ,secret>y may by ord] e/abli% p]=mance /&>ds = an 9 vitro cl9ical te/ or te/s ) ! same indication = use to provide reasonable assurance ( ! analytical validity1 cl9ical validity1 or z applicable safety1 ( t 9 vitro cl9ical te/ or te/s ) ! same indications = use4 7b7 ,o!r /&>ds ,! ,secret>y may recognize all or "p ( appropriate /&>ds e/abli%$ by nationally or int]nationally recogniz$ /&>d 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 ,9 recogniz+ a /&>d1 any p]son reque/+ recognition ( a /&>d or seek+ to use a recogniz$ /&>d1 ! ,secret>y %all foll[ ! processes & requirem5ts1 9 accordance ) section #ead7;c74 ,/&>ds = 9 vitro diagno/ic devices previ\sly recogniz$ "u section #ead7;c7 %all be consid]$ recogniz$ /&>ds "u ?is section4 ,! application ( any su* cons5sus /&>d %all only apply prospectively4 ,! ,secret>y %all issue guidance e/abli%+ ! crit]ia & process = su* recognition & adoption4 7c7 ,ord] process ,9 e/abli%+ a /&>d "u subsection 7a71 ! ,secret>y %all issue a draft ord] propos+ to e/abli% a /&>d & %all provide = a comm5t p]iod ( n less ?an #fj cal5d> days4 ,! ,secret>y may *oose to seek ! recomm5dation ( an advisory committee "u section #ehg;,g conc]n+ a propos$ /&>d ei!r prior to or aft] issuance ( a propos$ ord]4 ,aft] consid]+ ! comm5ts & )9 #ij days ( ! close ( ! comm5t p]iod1 ! ,secret>y %all issue a f9al ord] adopt+ ! propos$ /&>d1 adopt+ a modification ( ! propos$ /&>d or t]m9at+ ! proce$+4 7d7 ,am5dm5t process ,! proc$ures e/abli%$ 9 ?is section or 9 guidance issu$ "u ?is section %all apply to am5dm5t ( an exi/+ /&>d4 #ehg,r4 ,inve/igational use 7a7 ,9 g5]al ,except z provid$ 9 subsection 7c71 an 9 vitro cl9ical te/ = inve/igational use %all be exempt f ! requirem5ts ( ?is sub*apt] o!r ?an sections #ehg;,a1 #ehg,o1 & #ehg,u4 7b7 ,regulations ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,v]ify+ ,accurate ,lead+-edge ,,ivct ,developm5t ,act ( #bjbj1 ! ,secret>y %all promulgate regulations to implem5t ?is section4 7c7 ,application = inve/igational use 7#a7 ,9 g5]al ,! foll[+ %all apply ) respect to 9 vitro cl9ical te/s = inve/igational use3 7,a7 ,/reaml9+ applications submitt$ "u ?is section ,requirem5ts ) respect to su* te/s %all be complet$ 9 accordance ) curr5t inve/igational use requirem5ts = in/itutional review bo>ds & curr5t processes = any analytical or cl9ical validation4 7,b7 ,v>iation ,! requirem5ts 9 ! regulations promulgat$ "u ?is section %all take into acc\nt v>iations bas$ on-- 7i7 ! scope & duration ( cl9ical te/+ to be conduct$ "u inve/igation t is ! subject ( su* application2 7ii7 ! numb] ( human subjects t are to be involv$ 9 su* te/+2 7iii7 ! ne$ to p]mit *anges to be made 9 ! 9 vitro cl9ical te/ involv$ dur+ te/+ conduct$ 9 accordance ) a plan requir$ "u p>agraph 7#c77;,b72 or 7iv7 :e!r ! cl9ical te/+ ( su* 9 vitro cl9ical te/ is = ! purpose ( develop+ data to obta9 approval to (f] su* te/4 7,c7 ,significant risk /udies ,9 ! case ( an 9 vitro cl9ical te/ ! inve/igational use ( :i* poses a significant risk1 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 ! te/ 9 accordance ) p>agraphs 7#b7 & 7#c74 ,= purposes ( ?is subp>agraph1 ! t]m significant risk means1 ) respect to an 9 vitro cl9ical te/ t is a high-risk te/1 & t ! use ( ! te/-- 7i7 is a use ( sub/antial importance 9 p]=m+ an activity or activities describ$ 9 subsection 7ss77#a77;,a7 =1 a s]i\s or life-?reat5+ disease or condition )\t confirmation ( ! diagnosis by a m$ically e/abli%$ means2 7ii7 requires an invasive sampl+ proc$ure t pres5ts a significant risk to ! human subject2 or 7iii7 o!rwise pres5ts a reasonably =eseeable s]i\s risk to ! heal? ( a human subject4 7,d7 ,non-significant risk te/s ,9 ! case ( an 9 vitro cl9ical te/1 ! inve/igational use ( :i* does n pose a significant risk-- 7i7 ! sponsor ( su* inve/igation %all-- 7,i7 conduct su* inve/igation 9 compliance ) an inve/igational plan specifi$ 9 p>agraph 7#e7 & label+ specifi$ 9 p>agraph 7#c77;,a77ii72 7,,ii7 ensure ea* inve/igator obta9s in=m$ cons5t "u "p #ej ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations71 subject to ! exceptions set =? 9 p>agraphs 7#e77;,a77iii7 & 7#e77;,b72 7,,iii7 submit a li/+ to ! ,secret>y ( su* inve/igation2 & 7,,iv7 ma9ta9 records ) respect to all requirem5ts 9 ?is subp>agraph2 & 7ii7 ! sponsor may rely on any exception or exemption id5tifi$ 9 p>agraph 7#e77;,b7 or z e/abli%$ by ! ,secret>y 9 regulations issu$ "u subsection 7b74 7#b7 ,application cont5t ,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 = approval specifi$ 9 p>agraph 7#c72 7ii7 to review ! progress ( ! inve/igation involv$2 & 7iii7 to evaluate ! analytical validity & cl9ical validity ( su* te/4 7#c7 ,conditions ( approval 7,a7 ,9 g5]al ,an inve/igational use application ) respect to significant risk te/s %all only be approv$ if ea* ( ! foll[+ conditions is met3 7i7 ,! risks to ! subjects ( ! 9 vitro cl9ical te/ are outweigh$ by ! anticipat$ b5efits to ! subjects & ! importance ( ! k to be ga9$1 & adequate assurance ( in=m$ cons5t is provid$ 9 accordance ) p>agraph 7#e77;,a77iii74 7ii7 ,! propos$ label+ = ! 9 vitro cl9ical te/ involv$ cle>ly & conspicu\sly /ates ,= inve/igational use4 7iii7 ,su* o!r requirem5ts ! ,secret>y det]m9es to be necess>y = ! protection ( ! public heal? & safety z long z ! requirem5ts d n unduly delay inve/igation aft] f9d+ t ! results ( su* inve/igation e/abli% suffici5t data to support cl9ical or analytical validity4 7,b7 ,c]ta9 significant risk 9 vitro cl9ical te/s = an unmet ne$ ,z a condition ( approval "u ?is p>agraph1 ! ,secret>y %all n impose a limit on ! sample size = a significant risk 9 vitro cl9ical te/ t meets ! requirem5ts ( section #ehg;,c1 z long z su* te/ is develop$ )9 a laboratory t is c]tifi$ to conduct high-complexity te/+ "u section #cec ( ! ,public ,heal? ,s]vice ,act4 7#d7 ,coord9ation ) inve/igational new drug applications ,any requirem5t = ! submission ( a report to ! ,secret>y pursuant to an inve/igational new drug application involv+ an 9 vitro cl9ical te/ %all sup]s$e ! report+ requirem5t 9 p>agraph 7#b77;,b71 b only to ! ext5t ! requirem5t ) respect to ! inve/igational new drug application is duplicative ( ! report+ requirem5t "u su* p>agraph4 7#e7 ,inve/igation plan requirem5ts 7,a7 ,9 g5]al ,) respect to an inve/igational plan submitt$ "u p>agraph 7#b77;,a71 ! sponsor submitt+ su* plan %all-- 7i7 9 ! case ( su* a plan submitt$ to an in/itutional review committee1 promptly notify ! ,secret>y ( ! approval or ! susp5sion or t]m9ation ( ! approval ( su* plan by an in/itutional review committee2 7ii7 9 ! case ( an 9 vitro cl9ical te/ made available to inve/igators = cl9ical te/+1 assurance t all inve/igators w comply ) ?is section1 regulations promulgat$ or revis$ "u ?is section1 & applicable human subjects regulations2 & 7iii7 submit an assurance to ! ,secret>y 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 9 ! case t-- 7,i7 !re is a life-?reat5+ situation involv+ ! human subject ( su* te/+ :i* necessitates ! use ( su* 9 vitro cl9ical te/2 7,,ii7 x is n feasible to obta9 in=m$ cons5t f ! subject2 & 7,,iii7 !re is n suffici5t "t to obta9 su* cons5t f a repres5tative ( su* subject4 7,b7 ,exception ,! in=m$ cons5t ( human subjects %all n be requir$ ) respect to cl9ical te/+ conduct$ z "p ( an inve/igation1 if-- 7i7 ! cl9ical te/+ uses remnants ( specim5s collect$ = r\t9e cl9ical c>e or analysis t w\ld h be5 disc>d$1 leftov] specim5s t 7 previ\sly collect$ = o!r rese>* purposes1 or specim5s obta9$ f specim5 repositories2 7ii7 ! id5tity ( ! subject ( ! specim5 is n kn[n to1 & may n readily be asc]ta9$ by1 ! inve/igator or any o!r individual associat$ ) ! inve/igation1 includ+ ! sponsor2 7iii7 any cl9ical in=mation t accompanies ! specim5s does n make ! specim5 s\rce id5tifiable to ! inve/igator or any o!r individual associat$ ) ! inve/igation1 includ+ ! sponsor2 7iv7 ! individuals c>+ = ! human subjects z pati5ts are diff]5t f1 & d n %>e in=mation ab\t ! pati5t )1 ! individuals conduct+ ! inve/igation2 & 7v7 ! specim5s are provid$ to ! inve/igators )\t p]sonally id5tifiable in=mation & ! suppli] ( ! specim5s has e/abli%$ policies & proc$ures to prev5t ! release ( p]sonally id5tifiable in=mation4 7d7 ,review ( applications 7#a7 ,9 g5]al ,! ,secret>y may issue an ord] approv+ an inve/igation z propos$1 approv+ x ) conditions or modifications1 or disapprov+ x4 7#b7 ,failure to act ,unless ! ,secret>y1 n lat] ?an ! date t is #cj cal5d> days aft] ! date ( ! submission ( an inve/igational use application t meets ! requirem5ts ( subsection 7c77#b71 issues an ord] "u subsection 7d77#a7 & notifies ! sponsor submitt+ ! application1 ! application %all be treat$ z approv$ z ( su* date )\t fur!r action by ! ,secret>y4 7#c7 ,disapproval ,! ,secret>y may disapprove 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 7c77#c74 ,a li/+ ( su* disapproval submitt$ to ! sponsor ) respect to su* an application %all conta9 ! ord] ( disapproval & a complete /atem5t ( ! reasons = ! ,secret>y's disapproval ( ! application4 7e7 ,)drawal ( approval 7#a7 ,9 g5]al ,! ,secret>y may1 by adm9i/rative ord]1 )draw ! approval ( an exemption grant$ "u ?is section ) respect to an 9 vitro cl9ical te/1 includ+ an exemption grant$ bas$ on ! ,secret>y's failure to act pursuant to subsection 7d77#b71 if ! ,secret>y det]m9es t ! te/ does n meet ! applicable conditions "u subsection 7c77#c7 = su* approval4 7#b7 ,opportunity to be he>d 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 an ord] )draw+ ! approval ( an exemption grant$ "u ?is section may be issu$ only aft] ! ,secret>y provides ! applicant or sponsor ( ! te/ ) an opportunity = an in=mal he>+4 7,b7 ,exception ,an ord] ref]r$ to 9 subp>agraph 7,a7 ) respect to an exemption grant$ "u ?is subsection 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$ures & conditions "u :i* ! *anges to ! te/ are all[$ )\t ! additional approval ( an application = an exemption or ! approval ( a supplem5t to su* an application4 ,su* regulations %all provide t su* a *ange may be made if-- 7,a7 ! sponsor or applicant det]m9es1 on ! basis ( cr$ible in=mation 7z def9$ by ! ,secret>y7 t ! *ange meets ! conditions specifi$ 9 p>agraph 7#b72 & 7,b7 ! sponsor or applicant 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/ 7includ+ manufactur+ *anges71 ! *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 7if any7 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 protocol2 7ii7 ! sci5tific s\ndness ( a plan submitt$ "u subsection 7c77#e72 or 7iii7 ! rights1 safety1 or welf>e ( ! human subjects 7if any7 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 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 or sponsor may imm$iately appeal any su* det]m9ation pursuant to section #ehg,o4 7#b7 ,det]m9ation ,= purposes ( p>agraph 7#a71 a det]m9ation describ$ 9 ?is subp>agraph ) respect to a cl9ical hold is a det]m9ation t-- 7,a7 ! 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$2 7,b7 ! cl9ical hold %\ld be issu$ = su* o!r reasons z ! ,secret>y may by regulation e/abli%2 or 7,c7 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,s4 ,collaborative communities = 9 vitro cl9ical te/s 7a7 ,9 g5]al 7#a7 ,= ! purposes ( facilitat+ community solutions & decision mak+ ) respect to 9 vitro cl9ical te/s1 ! ,secret>y may p>ticipate 9 collaborative communities compris$ ( public & private p>ticipants t may provide recomm5dations & o!r advice to ! ,secret>y on ! developm5t & regulation ( 9 vitro cl9ical te/s4 7#b7 ,a collaborative community "u ?is section %all h broad repres5tation ( int]e/$ private & public-sector /akehold] communities & may include pati5ts1 c>e p>tn]s1 academics1 heal?c>e pr(essionals1 heal?c>e sy/ems1 pay]s1 ,f$]al & ,/ate ag5cies1 entities responsible = accr$it+ cl9ical laboratories1 int]national regulatory bodies1 te/ develop]s1 or o!r int]e/$ entities or communities4 7b7 ,guidance ,! ,secret>y %all issue a draft guidance n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,v]ify+ ,accurate ,lead+-edge ,,ivct ,developm5t ,act ( #bjbj1 address+ ! p>ticipation process & framework to build cons5sus1 & h[ ! ,secret>y may consid]1 review1 & implem5t recomm5dations "u subsection 7c74 7c7 ,recomm5dations ,a collaborative community = 9 vitro cl9ical te/s may make recomm5dations to ! ,secret>y on matt]s includ+-- 7#a7 mitigat+ measures = 9 vitro cl9ical te/s2 7#b7 /&>ds developm5t activities & p]=mance /&>ds = 9 vitro cl9ical te/s or gr\ps ( su* te/s2 7#c7 sci5tific & cl9ical evid5ce to support new claims = 9 vitro cl9ical te/s2 7#d7 new te*nologies & me?odologies relat$ to 9 vitro cl9ical te/s2 7#e7 /akehold] communication & engagem5t2 & 7#f7 developm5t ( effective policies & processes1 includ+ to develop te/s1 & to regulate su* te/s 9 accordance ) lea/ burd5some pr9cipals "u ?is ,act4 7d7 ,use by ,secret>y 7#a7 ,9 g5]al ,! ,secret>y may adopt recomm5dations made "u subsection 7b71 or o!rwise incorporate ! fe$back f collaborative communities into regulatory decision mak+1 ?r\gh rulemak+ or guidance1 z appropriate4 7#b7 ,cl>ification ,! ,secret>y is n requir$ to adopt recomm5dations submitt$ by collaborative communities4 7e7 ,transp>5cy ,! ,secret>y %all-- 7#a7 publi% on ! int]net website ( ! ,food & ,drug ,adm9i/ration matt]s = :i* x is seek+ comm5ts or recomm5dations1 9 a timely mann]2 7#b7 ma9ta9 a li/ ( all collaborative communities 9 :i* ! ,secret>y p>ticipates & make su* li/ available on ! int]net website ( ! ,food & ,drug ,adm9i/ration2 & 7#c7 po/ on ! int]net website ( ! ,food & ,drug ,adm9i/ration at lea/ once e ye> a report on ! recomm5dations x has adopt$ & recomm5dations x has n adopt$ f collaborative communities4 7f7 ,p>ticipation ,! ,secret>y may p>ticipate 9 a collaborative community only if su* community requires memb]s to disclose conflicts ( int]e/ & has e/abli%$ a process to address conflicts ( int]e/4 7g7 ,exception ,! ,f$]al ,advisory ,committee ,act 9 ! app5dix to title #e %all n apply to collaborative communities e/abli%$ & us$ 9 accordance ) ?is section4 #ehg,t4 ,compreh5sive te/ in=mation sy/em 7a7 ,purpose ,= ! purposes ( improv+ ! transp>5cy ( in=mation on 9 vitro cl9ical te/s & all[+ pati5ts & heal? c>e provid]s bett] access to in=mation ab\t 9 vitro cl9ical te/s1 ! ,secret>y %all e/abli% a compreh5sive te/ in=mation sy/em4 7b7 ,e/abli%m5t ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,v]ify+ ,accurate ,lead+-edge ,,ivct ,developm5t ,act ( #bjbj1 ! ,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 ! int]net website ( ! ,food & ,drug ,adm9i/ration = /akehold]s1 to ! ext5t p]mitt$ by applicable law1 to access !-- 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;,i1 includ+ ! use ( a l9k = labels2 7,c7 adv]se ev5t reports submitt$ "u section #ehg,l2 7,d7 reports ( corrections & removals submitt$ "u section #ehg,m2 & 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 reports4 7c7 ,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 ,no ,/ate1 tribal1 or local gov]nm5t 7or political subdivision !re(7 may e/abli% or cont9ue 9 effect any requirem5t relat$ to ! developm5t1 manufacture1 label+1 di/ribution1 sale1 or use ( an 9 vitro cl9ical te/ t is diff]5t f1 or 9 addition to1 ! requirem5ts ( ?is sub*apt]4 7b7 ,exceptions ,subsection 7a7 %all n be con/ru$ to affect ! au?ority ( a ,/ate1 tribal1 or local gov]nm5t-- 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%ip2 or 7#b7 to en=ce laws ( g5]al applicability1 su* z zon+ laws1 environm5tal laws1 labor laws1 & g5]al bus9ess laws4 7c7 ,cl>ification ,?is section %all n be con/ru$ to %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$1 9 :ole or 9 "p1 ( any poison\s or delet]i\s sub/ance :i* may r5d] ! cont5ts injuri\s to heal?4 7#d7 ,if x be>s or conta9s1 = purposes ( color+ only1 a color additive :i* is unsafe )9 ! mean+ ( section #gba7;a74 7#e7 ,if its analytical or cl9ical validity1 or ) respect to a specim5 receptacle1 its safety1 or its /r5g?1 purity1 or quality1 diff]s f or falls bel[ t :i* x purports or is repres5t$ 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,q & is n 9 all respects 9 con=mity ) su* /&>d4 7#g7 ,if x is requir$ to be 9 con=mity ) a mitigat+ measure e/abli%$ "u section #ehg;,e & is n 9 all respects 9 con=mity ) su* mitigat+ measure4 7#h7 ,if x fails to h an approv$ prem>ket application "u section #ehg;,b unless su* 9 vitro cl9ical te/ c be lawfully (f]$-- 7,a7 = cl9ical use pursuant to an exemption "u section #ehg;,a2 7,b7 = em]g5cy use pursuant to an au?orization "u section #efd2 or 7,c7 = inve/igational use pursuant to section #ehg,r4 7#i7 ,if x is n 9 con=mity ) any condition e/abli%$ "u section #ehg;,b1 #ehg;,d1 or #efd4 7#aj7 ,if x purports to be an 9 vitro cl9ical te/ t is (f]$ = cl9ical use subject to an exemption "u section #ehg;,a & 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,r = 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;,j 7z applicable71 or ! me?ods us$ 91 or facilities or controls us$ =1 its developm5t1 manufacture1 pack+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 manufactur$1 process$1 pack$ 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,n4 #ehg,w4 ,misbr&+ ,an 9 vitro cl9ical te/ %all be deem$ to be misbr&$3 7#a7 ,if its label+ is false or mislead+ 9 any p>ticul>4 7#b7 ,if 9 a package =m unless x be>s a label conta9+-- 7,a7 ! "n & place ( bus9ess ( ! te/ develop]1 manufactur]1 pack]1 or di/ributor2 & 7,b7 an accurate /atem5t ( ! quantity ( cont5ts 9 t]ms ( weight1 measure1 or num]ical c\nt ) respect to small packages1 unless an exemption is grant$ by ! ,secret>y by ! issuance ( guidance4 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 facilities 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 manufactur]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 x causes 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$ or manufactur$ 9 an e/abli%m5t n duly regi/]$ "u section #ehg;,i or x 0 n includ$ 9 a li/+ "u section #ehg;,i1 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,n1 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]1 manufactur]1 or di/ributor includes 9 all adv]tisem5ts & o!r descriptive pr9t$ matt] t su* p]son issues or causes to be issu$1 a brief /atem5t ( ! int5d$ uses ( ! 9 vitro cl9ical te/ & relevant w>n+s1 precautions1 side effects1 & contra9dications4 ,?is subsection %all n be applicable to any pr9t$ matt] t ! ,secret>y det]m9es to be label+ z def9$ 9 section #bja7m7 or section #ehg,k4 7#h7 ,if x 0 subject to a mitigat+ measure e/abli%$ "u section #ehg;,e1 unless x be>s su* label+ z may be prescrib$ 9 su* mitigat+ measure4 7#i7 ,if x 0 subject to a /&>d e/abli%$ "u section #ehg,q1 unless x be>s su* label+ z may be prescrib$ 9 su* /&>d4 7#aj7 ,unless x be>s su* label+ z may be prescrib$ by or e/abli%$ "u an applicable label+ requirem5t "u ?is ,act4 7#aa7 ,if !re 0 a failure or refusal to comply ) any requirem5t prescrib$ "u section #ehg;,i or #ehg,x1 or to comply ) a requirem5t "u section #ehg,y1 or to provide any report1 mat]ial1 or in=mation requir$ "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] to conduct po/m>ket surveillance ( a s+le 9 vitro cl9ical te/ z a condition ( approval "u section #ehg;,b4 7#b7 ,exempt te/s ,! ,secret>y may ord] po/m>ket surveillance = te/s exempt pursuant to section #ehg;,a = :i* ! failure ( ! 9 vitro cl9ical te/ to meet ! applicable /&>d = approval is likely to result 9 s]i\s or adv]se heal? consequ5ces or dea? f use ( ! s+le 9 vitro cl9ical te/4 7#c7 ,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 pr9ciples "u section #ehg;,b4 7b7 ,surveillance approval 7#a7 ,ea* develop] requir$ to conduct a 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 ,! 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 ,! ,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 & ! manufactur] or1 if no agreem5t c be rea*$1 aft] ! completion ( a dispute resolution process4 #ehg,y4 ,electronic =mat = submissions 7a7 ,9 g5]al ,all presubmissions & submissions to ! ,food & ,drug ,adm9i/ration ) respect to an 9 vitro cl9ical te/ %all include an electronic copy ( su* presubmission or submission1 &1 ) respect to ! in=mation requir$ "u sections #ehg;,b & #ehg;,d1 %all 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 presubmissions & submissions = 9 vitro cl9ical te/s 7& any appeals ( action tak5 by ! ,secret>y ) respect to su* presubmissions & submissions7 %all be submitt$ solely 9 su* electronic =mat z specifi$ by ! ,secret>y 9 su* guidance4 7c7 ,guidance ,! ,secret>y %all issue guidance implem5t+ ?is section4 ,9 su* guidance1 ! ,secret>y may-- 7#a7 provide /&>ds = ! electronic copy requir$ "u subsection 7a7 or ! submission 9 electronic =mat requir$ "u subsection 7b72 7#b7 set =? crit]ia = waiv]s ( or exemptions f ! 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 manufactur]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 advise ! 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 developm5t or manufacture2 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 manufactur]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 manufactur]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 ,)9 #cj cal5d> days ( issu+ an ord] "u subp>agraph 7,a71 ! ,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$1 or 7ii7 aft] af=d+ an opportunity = an in=mal he>+1 by ord] prescribe a plan to be c>ri$ out by a p]son :o is a manufactur]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$4 7#b7 ,actions on a plan ,! actions :i* may be tak5 "u a plan submitt$ "u an ord] issu$ "u p>agraph 7#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 manufactur]1 import]1 di/ributor 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 avail+ himself ( 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 manufactur]1 import]1 di/ributor1 or retail] ( ! 9 vitro cl9ical te/ to reimburse any o!r p]son :o is a develop]1 manufactur]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 w\ld cause s]i\s1 adv]se heal? consequ5ces or dea?1 includ+ by ! abs5ce1 delay1 or discont9uation ( appropriate m$ical treatm5t1 ! ,secret>y %all issue an ord] requir+ ! appropriate p]son 7includ+ ! develop]s1 manufactur]s1 import]s1 di/ributors1 or retail]s ( ! 9 vitro cl9ical te/7-- 7,a7 to imm$iately cease di/ribution ( su* 9 vitro cl9ical te/2 & 7,b7 to imm$iately notify heal? pr(essionals & us] facilities ( ! ord] & to in/ruct su* pr(essionals & facilities to cease use ( su* 9 vitro cl9ical te/4 7#b7 ,in=mal he>+ ,! ord] issu$ "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 7b7 & 7c74 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 7k71 7q71 7r71 & 7y71 by ins]t+ 9 vitro cl9ical te/1 aft] device1 ea* place x appe>s2 7#b7 9 p>agraph 7y7 by ins]t+ or #ehg,p aft] section #ebc ea* place x appe>s2 & 7#c7 by add+ at ! end1 ! foll[+3 7fff7 7#a7 ,! introduction or deliv]y = introduction into int]/ate comm]ce ( an 9 vitro cl9ical te/ 9 violation ( section #ehg;,b7a74 7#b7 ,! false1 fraudul5t1 or deceptive claim+ = an 9 vitro cl9ical te/ ( an exemption f ! prem>ket review requir$ "u section #ehg;,b4 7#c7 ,:5 claim+ an exemption "u section #ehg;,a f ! prem>ket review requir$ "u section #ehg;,b1 ! failure to ma9ta9 complete & accurate docum5tation = ! exemption z requir$ "u section #ehg;,a or ! failure to provide label+ requir$ "u section #ehg;,a4 7#d7 ,) respect to an 9 vitro cl9ical te/1 ! submission ( any report t is requir$ by or "u ?is ,act t is false or mislead+ 9 any mat]ial respect4 7#e7 ,! mak+ ( a false1 fraudul5t1 or mat]ially deceptive analytical or cl9ical claim = an 9 vitro cl9ical te/-- 7,a7 9 any application1 report1 or notification submitt$ to ! ,secret>y "u ?is ,act2 or 7,b7 9 ! label+ or adv]tis+ ( an 9 vitro cl9ical te/4 7#f7 ,! failure to comply ) a condition ( approval1 p]=mance /&>d1 mitigat+ measure1 or re/riction e/abli%$ 9 an ord] approv+ an application or supplem5t "u section #ehg;,b2 ! failure to p]=m a risk analysis requir$ by section #ehg;,b2 ! failure to submit an annual report requir$ "u section #ehg;,b7k72 or ! failure to complete po/m>ket /udies requir$ "u section #ehg,v4 7#g7 ,! m>ket+ ( an 9 vitro cl9ical te/ 9 violation (-- 7,a7 an ord] issu$ by ! ,secret>y "u section #ehg;,a2 or 7,b7 any requirem5t "u section #ehg;,a4 7#h7 ,) respect to te*nology c]tification "u section #ehg;,d1 ! refusal to p]mit1 or unreasonable delay 9 p]mitt+1 an inspection au?oriz$ "u section #ehg;,d7f77#c77;,g72 ! failure to comply ) applicable requirem5ts to submit an application or report "u section #ehg;,d7e72 or ! failure to comply ) applicable ma9t5ance requirem5ts "u section #ehg;,d7h74 7#i7 ,! failure to comply ) an applicable mitigat+ measure e/abli%$ "u section #ehg;,e or to ma9ta9 ! docum5tation requir$ "u section #ehg;,e7b72 or ! failure to comply ) a p]=mance /&>d e/abli%$ "u section #ehg,q4 7#aj7 ,! failure to regi/] 9 accordance ) section #ehg;,i1 ! failure to provide in=mation requir$ "u section #ehg;,i7b71 or ! failure to ma9ta9 or submit in=mation requir$ "u section #ehg;,i7c74 7#aa7 ,! failure to submit a report requir$ "u section #ehg,l or #ehg,m2 ! failure to comply ) a re/riction impos$ "u section #ehg,n2 or ! failure to comply ) label+ & adv]tis+ requirem5ts "u section #ehg,n7b74 7#ab7 ,! failure to comply ) ! requirem5ts ( section #ehg,p 7relat+ to accr$it$ p]sons74 7#ac7 ,! failure to comply ) any requirem5t prescrib$ or e/abli%$ "u section #ehg,r2 ! failure to furni% any notification1 in=mation1 mat]ial1 or report requir$ "u section #ehg,r2 or ! failure to comply ) an ord] issu$ "u section #ehg,r4 4 7b7 ,p5alties ,section #cjc7;f77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7;f77#a77 is am5d$-- 7#a7 9 subp>agraph 7,a71 by ins]t+ or 9 vitro cl9ical te/s aft] devices2 & 7#b7 9 subp>agraph 7,b77i7-- 7,a7 by ins]t+ 1 or #ehg;,j or #ehg,l1 aft] #ebj7;f72 & 7,b7 by ins]t+ 1 or :o violates section #ehg,m7b7 ) respect to a correction report aft] risk to public heal?4 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+ & be=e 7,e7 ,any2 & 7,b7 by ins]t+ 1 & 7,f7 ,any adult]at$ or misbr&$ 9 vitro cl9ical te/ aft] tobacco product2 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 "u section #cja7;gg71 #cja7;fff77#b71 #cja7;fff77#e71 or #cja7;fff77#h71 ! ,secret>y %all deb> su* p]son f be+ accr$it$ "u section #ehg,p & 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 ,judicial review ,section #eag7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;g7a77 is am5d$-- 7#a7 9 p>agraph 7#h71 by /rik+ or at ! end2 7#b7 9 p>agraph 7#i71 by ins]t+ or aft] ! comma at ! end2 & 7#c7 be=e ! matt] t foll[s p>agraph 7#i71 by ins]t+ ! foll[+3 7#aj7 an ord] issu$ pursuant to section #ehg;,b1 #ehg;,d1 #ehg,r1 or #ehg,s1 4 7f7 ,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 & 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 & ins]t+ 1 #ebj7;g71 or #ehg,r ea* place x appe>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/ exemptions2 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,r2 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 ! matt] foll[+ p>agraph 7#g7 by /rik+ or #ebj7;g7 ea* place x appe>s & ins]t+ 1 #ebj7;g7 or #ehg,r2 & 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 7g7 ,optimiz+ global cl9ical trials ,section #efi;,a7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#h;a7b77 is am5d$ by ins]t+ an 9 vitro cl9ical te/1 z def9$ 9 subsection 7ss7 ( su* section1 be=e or a biological product4 7h7 ,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 7i7 ,regulations & he>+s ,section #gja7;h77#a77;,c77ii7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cga7;h77#a77;,c77ii77 is am5d$ by ins]t+ & 9 vitro cl9ical te/s aft] devices4 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 ! ?ird s5t5ce1 by /rik+ or *apt] ,,ix & ins]t+ section #ehg,r or *apt] ,,ix2 7#c7 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#d7 by ins]t+ 9 vitro cl9ical te/1 aft] device1 ea* place x appe>s2 7#e7 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#f7 9 subsection 7e71 by ins]t+ 1 or section #ehg,l1 #ehg,m1 or #ehg,r1 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,p4 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 ,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;,j1 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] device14 7n7 ,(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$+ p>agraph 7#a71 by ins]t+ & 9 vitro cl9ical te/s aft] devices2 & 7,b7 9 p>agraph 7#a71 by ins]t+ quality requirem5ts e/abli%$ "u section #ehg;,j2 & at ! end2 & 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 7o7 ,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 section #ehg;,i aft] #eaj7;h74 7p7 ,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 7q7 ,(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 /rik+ & device manufactur]s & ins]t+ device manufactur]s1 & 9 vitro cl9ical te/ develop]s14 7r7 ,c\nt]measure provisions ( ! ,,phsa ,title ,,iii ( ! ,,phsa is am5d$-- 7#a7 9 section #cai;,f-#b7;c77#a77;,b7 7#db ,u4,s4,c4 #bdg;d-#f;b7c77#a77;,b77 is am5d$-- 7,a7 by /rik+ or device & ins]t+ device2 & 7,b7 by ins]t+ or an 9 vitro cl9ical te/ 7z t t]m is def9$ 9 section #bja7ss7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7ss777 aft] ,act 7#ba ,u4,s4,c4 #cba7;h7772 7#b7 9 section #cai;,f-#a7;a77#b7 7#db ,u4,s4,c4 #bdg;d-#f;a7a77#b771 by ins]t+ an 9 vitro cl9ical te/s 7z t t]m is def9$ 9 section #bja7ss7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7ss7771 be=e or device2 & 7#c7 9 section #cai;,f-#c7;i77#g7 7#db ,u4,s4,c4 #bdg;d-#f;d7i77#g771 by ins]t+ an 9 vitro cl9ical te/s 7z t t]m is def9$ 9 section #bja7ss7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7ss7771 be=e or device4 #e4 ,transition 7a7 ,implem5tation 7#a7 ,9 g5]al ,except z o!rwise provid$ 9 ?is section1 ! am5dm5ts made by ?is ,act apply beg9n+ on ! fir/ day ( ! f\r? fiscal ye> t beg9s aft] ! date ( enactm5t ( ?is ,act 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 ,act71 except t ! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is section ref]r$ to z ! ,secret>y7 may take ! actions describ$ 9 p>agraph 7#b7 z describ$ 9 su* p>agraph1 & may take su* o!r actions1 & exp5d su* funds1 z ! ,secret>y det]m9es necess>y to ensure an ord]ly transition4 7#b7 ,actions ,! ,secret>y %all1 prior to ! date on :i* ! am5dm5ts made by ?is ,act g5]ally apply pursuant to p>agraph 7#a7-- 7,a7 )9 #b ye>s ( ! date ( enactm5t ( ?is ,act hold ! public meet+s describ$ 9 sub*apt] ,j ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #c2 7,b7 )9 #b ye>s ( ! date ( enactm5t ( ?is ,act promulgate regulations requir$ "u sections #ehg,l1 #ehg,m1 #ehg,v1 & #ehg,w2 7,c7 issue f9al guidance on prem>ket review requirem5ts "u section #ehg;,b1 te*nology c]tification review requirem5ts "u section #ehg;,d1 & applicability "u section #ehg;,a2 & 7,d7 promulgate additional regulations requir$ by su* am5dm5ts made by ?is ,act4 7#c7 ,applicability ( regulations ,not)/&+ ! date on :i* guidance or regulations are issu$ "u p>agraph 7#b71 no guidance or regulations issu$ pursuant to ! am5dm5ts made by ?is ,act %all take effect until ! effective date ( ?is ,act1 z describ$ 9 p>agraph 7#a71 except z o!rwise provid$ = transitional te/s4 7b7 ,application ( au?orities to ,9 vitro cl9ical te/s until & aft] effective date ( ?is ,act ,except z provid$ 9 subsection 7d71 = any product or te/ t is an 9 vitro cl9ical te/ z def9$ 9 section #bja7ss7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by ?is ,act1 ! foll[+ au?orities %all apply3 7#a7 ,te/s (f]$ prior to enactm5t ,an 9 vitro cl9ical te/ t meets ! crit]ia = a gr&fa!r$ te/ z set =? 9 section #ehg;,a7c77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #c1 may cont9ue to be (f]$ = cl9ical use & %all be subject only to applicable provisions ( section #cec ( ! ,public ,heal? ,s]vice ,act & section #ehg;,a7a77#d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #c4 7#b7 ,te/s (f]$ on or aft] enactm5t b be=e implem5tation ,be=e any product or te/ t is an 9 vitro cl9ical te/ z def9$ 9 section #bja7ss7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by ?is ,act1 is fir/ (f]$1 sold1 or di/ribut$ aft] ! date ( enactm5t ( ?is ,act1 b prior to #ij days be=e ! effective date ( ?is ,act1 su* product or te/ %all be consid]$ a transitional te/ z describ$ "u subsection 7d7 & comply ) ! applicable device provisions ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq47 & ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bja et seq474 7#c7 ,te/s "u review beg9n+ on or aft] ! date ( enactm5t ( ?is act b prior to implem5tation ,= any product or te/ t is an 9 vitro cl9ical te/ z def9$ 9 section #bja7ss7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by ?is ,act1 = :i* a submission = m>ket+ au?orization "u section #eae1 cle>ance "u section #eaj7k71 au?orization "u section #eac7;f77#b71 approval "u section #ebj7m71 or em]g5cy use au?orization "u section #efd ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e1 #cfj7k71 #cfj;c7f77#b71 #cfj;j7m71 #cfj;bbb-#c7 or approval "u ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bja et seq47 is p5d+ on ! effective date ( ?is ,act1 ! ,secret>y may review & take action on su* submission aft] ! effective date ( ?is ,act accord+ to ! /atutory provision "u :i* su* submission 0 submitt$4 7c7 ,application ( au?orities to transitional & gr&fa!r$ ,9 vitro cl9ical te/s 7#a7 ,def9ition ,= purposes ( ?is p>agraph1 ! t]m transitional 9 vitro cl9ical te/ means an 9 vitro cl9ical te/1 z def9$ 9 section #bja7ss7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by ?is ,act1 t-- 7,a7 0 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/+ = use only )9 t c]tifi$ laboratory or ano!r laboratory )9 ! organization "u common own]%ip2 7,b7 does n h an approval "u section #eae1 a cle>ance "u section #eaj7k71 an au?orization "u section #eac7;f77#b71 an approval "u section #ebj7m71 or an em]g5cy use au?orization "u section #efd ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e1 #cfj7k71 #cfj;c7f77#b71 #cfj;j7m71 #cfj;bbb-#c7 or approval "u ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bja et seq472 & 7,c7 is fir/ (f]$ = cl9ical use dur+ ! p]iod beg9n+ on ! date ( enactm5t ( ?is ,act & end+ on ! implem5tation date ( ?is ,act4 7#b7 ,cont9u$ (f]+ ,not)/&+ subsection 7c71 a transitional 9 vitro cl9ical te/ may cont9ue to be (f]$ = cl9ical use until ! effective date ( ?is ,act1 z describ$ 9 subsection 7b77#a71 except t ! ,secret>y reta9s au?ority to en=ce ! device provisions ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq47 & ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bja et seq47 = any specific transitional 9 vitro cl9ical te/1 or any type ( transitional 9 vitro cl9ical te/1 z ! ,secret>y det]m9es necess>y to protect ! public f a s]i\s risk to heal?4 7#c7 ,prem>ket review or te*nology c]tification ,a transitional 9 vitro cl9ical te/ t is ! subject ( an application = prem>ket review "u section #ehg;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or te*nology c]tification application "u section #ehg;,d ( su* ,act1 z add$ by ?is ,act1 t is submitt$ )9 #ij days ( ! effective date ( ?is ,act may cont9ue to be (f]$1 sold1 or di/ribut$ until completion ( ! ,secret>y's review ( ! prem>ket application or te*nology c]tification application4 7d7 ,conv]sion 7#a7 ,deem$ prem>ket approval ,any 9 vitro cl9ical te/ 7z def9$ 9 section #bja7ss7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by ?is ,act7 ) a prem>ket approval "u section #eae1 a cle>ance "u section #eaj7k71 an au?orization "u section #eac7;f71 or a lic5sure "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 is deem$ to h an approv$ application "u section #ehg;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by ?is ,act1 beg9n+ on ! lat] (-- 7,a7 ! effective date ( ?is ,act2 or 7,b7 su* o!r date1 n lat] ?an #c ye>s aft] su* effective date1 z ! p]son responsible = ! device selects4 7#b7 ,deem$ inve/igational use approval ,any 9 vitro cl9ical te/ 7z def9$ 9 section #bja7ss7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by ?is ,act7 t has an approv$ inve/igational device exemption "u section #ebj7;g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7g77 is deem$ to h an approv$ inve/igational use "u section #ehg,q ( su* ,act1 z add$ by ?is ,act1 beg9n+ on ! effective date ( ?is ,act4 7e7 ,in/rum5ts ,an in/rum5t 7z def9$ 9 section #ehg ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by ?is ,act7 t 0 pur*as$ prior to ! date ( enactm5t ( ?is ,act & 0 n cle>$1 au?oriz$1 or approv$ by ! ,food & ,drug ,adm9i/ration or "p ( an in/rum5t family t 0 cle>$1 au?oriz$1 or approv$ by ! ,food & ,drug ,adm9i/ration at ! "t ( pur*ase may cont9ue to be us$ by ! pur*as] to develop & introduce into int]/ate comm]ce an 9 vitro cl9ical te/ dur+ ! p]iod beg9n+ on ! date ( enactm5t ( ?is ,act & end+ #e ye>s aft] su* date ( enactm5t4 ,beg9n+ at ! end ( su* p]iod1 any new 9 vitro cl9ical te/ t is develop$ & introduc$ into int]/ate comm]ce %all be bas$ on an in/rum5t 7z def9$ 9 section #ehg7aa7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by section #c7 t complies ) ! requirem5ts ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z am5d$ by ?is ,act4 7f7 ,relation to ,9 vitro cl9ical te/ provision ,?is section applies not)/&+ section #ehg;,a7a77#a77;,c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by ?is ,act4 #f4 ,em]g5cy use au?orization ,section #efd ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c7 is am5d$-- 7#a7 9 p>agraphs 7#a7 & 7#d77;,c7 ( subsection 7a71 by ins]t+ 9 vitro cl9ical te/1 be=e or biological product ea* place su* t]m appe>s2 & 7#b7 9 subsection 7e77#c7-- 7,a7 9 subp>agraph 7,b71 by /rik+ & at ! end2 7,b7 9 subp>agraph 7,c71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7,c7 by add+ at ! end ! foll[+3 7,d7 quality sy/em requirem5ts 7) respect to 9 vitro cl9ical te/s7 "u section #ehg;,j4 4 #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+ or approve "u section #eae & ins]t+ approve "u section #eae1 or approve1 exempt1 or issue a te*nology c]tification ord] "u sub*apt] ,j2 & 7,b7 by /rik+ te/+ devices & ins]t+ te/s2 7#b7 9 subsection 7c77#e71 by /rik+ drug or device ea* place x appe>s & 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+ & #eae1 & ins]t+ #eae1 #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* 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 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;,b or exempt$ f prem>ket review "u section #ehg;,d4 2 & 7,d7 aft] mak+ ! am5dm5ts 9 subp>agraphs 7,b77ii71 7,b77iii71 & 7,c77ii71 by /rik+ device ea* place x appe>s & ins]t+ 9 vitro cl9ical te/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$+ subp>agraph 7,a7 to read z foll[s3 7#b7 ) respect to cle>+ "u section #eaj7k71 classify+ "u section #eac7;f77#b71 approv+ "u section #eae or section #ehg;,b1 or exempt+ f approval requirem5ts "u section #ehg;,d-- 2 & 7,b7 9 subp>agraph 7,a7-- 7i7 by /rik+ device & ins]t+ 9 vitro cl9ical te/2 & 7ii7 by /rik+ antimicrobial susceptibility te/+ device & ins]t+ antimicrobial susceptibility 9 vitro cl9ical te/4 #h4 ,comb9ation products 7a7 ,9 g5]al ,section #ejc7;g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;g77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9 subp>agraph 7,a7-- 7i7 by ins]t+ 7except = a comb9ation product con/itut$ ( a device & an 9 vitro cl9ical te/7 aft] ag5cy c5t]12 & 7ii7 by ins]t+ 9 vitro cl9ical te/1 be=e or biological product2 & 7,b7 9 subp>agraph 7,d7-- 7i7 9 ! matt] prec$+ clause 7i71 by /rik+ 4 ,if ! ,secret>y det]m9es & ins]t+ 1 except = a comb9ation product con/itut$ ( a device & an 9 vitro cl9ical te/4 ,= o!r comb9ation products1 if ! ,secret>y det]m9es2 & 7ii7 9 clause 7ii7-- 7,i7 by ins]t+ or 9 vitro cl9ical te/ aft] device2 & 7,,ii7 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 an exempt te/ "u section #ehg;,a1 z applicable2 & 7,b7 9 subp>agraph 7,b71 by ins]t+ or #ehg;,b aft] section #eae2 7#d7 9 p>agraph 7#e77;,a71 by /rik+ or #eaj7k7 & ins]t+ 1 #eaj7k71 or #ehg;,b2 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 comb9ation 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 or #ehg;,b2 & 7,b7 9 subp>agraph 7,d71 by /rik+ or #ebj & ins]t+ #ebj1 or #ehg;,b4 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 comb9ation product con/itut$ ( 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 #bjbj1 ! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is section ref]r$ to z ! ,secret>y7 %all develop recomm5dations to pres5t to ,congress ) respect to ! goals1 & plans = meet+ ! goals1 = ! process ( ! review ( 9 vitro cl9ical te/ applications submitt$ "u sub*apt] ,j ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by ?is ,act1 = ! fir/ #e fiscal ye>s aft] fiscal ye> #bjba4 ,9 develop+ su* recomm5dations1 ! ,secret>y %all consult )-- 7i7 ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives2 7ii7 ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate2 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 ( su* sub*apt] ,j1 ! ,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 su* sub*apt] ,j2 & 7iv7 publi% any comm5ts receiv$ "u clause 7iii7 on ! int]net 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 "u su* sub*apt] ,j & to solicit sugge/ions to be includ$ 9 ! recomm5dations transmitt$ to ,congress "u subp>agraph 7,e74 7,d7 ,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$]al ,regi/]2 7iii7 provide = a p]iod ( #cj days = ! public to provide writt5 comm5ts on su* recomm5dations2 7iv7 hold a meet+ at :i* ! public may pres5t its views on su* recomm5dations2 & 7v7 aft] consid]ation ( su* public views & comm5ts1 revise su* recomm5dations z necess>y4 7,e7 ,transmittal ( recomm5dations 7i7 ,9 g5]al ,n lat] ?an ,june #a1 #bjba1 ! ,secret>y %all transmit to ,congress ! revis$ 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 ! review ( 9 vitro cl9ical te/s1 are n support$ by ! funds au?oriz$ to be collect$ & assess$ "u section #gch ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j74 7,f7 ,publication ( recomm5dations ,! ,secret>y %all publi% on ! int]net website ( ! ,food & ,drug ,adm9i/ration ! revis$ recomm5dations "u subp>agraph 7,a71 a summ>y ( ! views & comm5ts receiv$ "u subp>agraphs 7,b7 ?r\gh 7,d71 & any *anges made to ! recomm5dations orig9ally propos$ by ! ,secret>y 9 response to su* views & comm5ts4 7,g7 ,m9utes ( negotiation meet+s 7i7 ,public availability ,be=e transmitt+ ! recomm5dations develop$ "u subp>agraphs 7,a7 ?r\gh 7,f7 to ,congress1 ! ,secret>y %all make publicly available1 on ! int]net website ( ! ,food & ,drug ,adm9i/ration1 m9utes ( all negotiation meet+s conduct$ "u ?is subsection betwe5 ! ,food & ,drug ,adm9i/ration & ! regulat$ indu/ry4 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 #bjba1 provid$ t ! ,secret>y transmits ! recomm5dations "u p>agraph 7#a77;,e71 ! ,secret>y is au?oriz$ to collect us] fees relat+ to ! submission ( 9 vitro cl9ical te/ applications submitt$ "u sub*apt] ,j ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by ?is ,act4 ,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 ,on ! date t is #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 & on a bi5nial basis !reaft] until ,octob] #a1 #bjbg1 ! ,secret>y %all p]=m an audit ( ! co/s ( review+ su* applications "u su* sub*apt] ,j4 ,su* an audit %all comp>e ! co/s ( review+ su* applications "u su* sub*apt] ,j to ! am\nt ( ! us] fee applicable to su* applications4 7,b7 ,alt]ation ( us] fee ,if ! audit p]=m$ "u subp>agraph 7,a7 indicates t ! us] fees applicable to applications submitt$ "u su* sub*apt] ,j exce$ #cj p]c5t ( ! co/s ( review+ su* applications1 ! ,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 ,conditions ,! us] fee program describ$ 9 ?is subsection %all take effect only if ! ,food & ,drug ,adm9i/ration issues draft guidance 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/ applications means ! foll[+ activities ( ! ,secret>y ) respect to ! review ( prem>ket applications "u section #ehg;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z add$ by section #c71 te*nology c]tification applications "u section #ehg;,d ( su* ,act 7z add$ by section #c71 & supplem5ts = su* applications3 7i7 ,! activities necess>y = ! review ( prem>ket applications1 prem>ket reports1 & supplem5ts to su* applications4 7ii7 ,! 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 place !m 9 condition = approval4 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 #bfb71 inve/igational new drug applications "u section #eje7;i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;i771 or inve/igational te/ exemptions "u section #ehg;,a7m7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z add$ by section #c71 & activities conduct$ 9 anticipation ( ! submission ( su* applications "u section #eje7;i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or inve/igational use "u section #ehg,r ( ! ,f$]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 ( an 9 vitro cl9ical te/4 7x7 ,evaluation ( po/m>ket /udies requir$ z a condition ( an approval ( a prem>ket application ( an 9 vitro cl9ical te/4 7xi7 ,compil+1 develop+1 & review+ in=mation on relevant 9 vitro cl9ical te/s to id5tify issues ) ! applicable /&>d = prem>ket applications1 te*nology c]tification applications1 & supplem5ts4 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> #bjba1 = 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;,e7 dur+ su* fiscal ye> & ! future plans ( ! ,food & ,drug ,adm9i/ration = meet+ ! goals4 7ii7 ,additional in=mation ,beg9n+ ) fiscal ye> #bjba1 ! 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$]al ,food1 ,drug1 & ,cosmetic ,act dur+ ! applicable fiscal ye> = ea* review division2 & 7,,iii7 ! numb] ( break?r\gh designations "u section #ehg;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act dur+ ! applicable fiscal ye>4 7iii7 ,real-"t report+ 7,i7 ,9 g5]al ,n lat] ?an #cj cal5d> days aft] ! end ( ! second qu>t] ( fiscal ye> #bjba1 & 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 ! int]net 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 guidance on topics relat$ to ! process = ! review ( 9 vitro cl9ical te/s1 & :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;,e74 7bb7 ,! 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;,e74 7iv7 ,rationale = ,,ivct us] fee program *anges ,beg9n+ ) fiscal ye> #bjbb1 ! ,secret>y %all include 9 ! annual p]=mance report "u p>agraph 7#a7-- 7,i7 data1 analysis1 & discussion ( ! *anges 9 ! numb] ( full-"t equival5ts hir$ z agre$ ^u 9 ! recomm5dations transmitt$ to ,congress by ! ,secret>y pursuant to subsection 7b77#a77;,e7 & ! 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/s1 includ+ id5tify+ driv]s ( su* *anges2 & 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$4 7v7 ,analysis ,= ea* fiscal ye>1 ! ,secret>y %all include 9 ! report "u clause 7i7 an analysis ( ! foll[+3 7,i7 ,! diff]5ce betwe5 ! aggregate numb] ( prem>ket applications fil$ "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;,e74 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;,e74 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;,e74 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;,e71 ! ,secret>y %all make su* in=mation publicly available on ! int]net 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> #bjbb1 = 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;,e7 = ! 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;,e7 = ! 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 ,= fiscal ye>s #bjba & annually !reaft]1 n lat] ?an #abj days aft] ! end ( ea* fiscal ye> dur+ :i* fees are collect$ "u ?is subp>t1 ! ,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,a7 ,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,b7 ,op]at+ res]ve ,su* report %all provide ! am\nt ( op]at+ res]ve balance available ea* ye>1 & any plann$ allocations or obligations ( su* balance t is above #aj weeks ( op]at+ res]ve = ! program4 7#d7 ,public availability ,! ,secret>y %all make ! reports requir$ "u p>agraphs 7#a7 ?r\gh 7#c7 available to ! public on ! int]net 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