,,ii #aad? ,,congress #a/ ,session ,s4 #ajgg ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,april #bc1 #bjae ,mr4 ,burr 7= himself1 ,mr4 ,b5net1 & ,mr4 ,hat*7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to provide = exp$it$ developm5t ( & priority review = break?r\gh devices4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,advanc+ ,break?r\gh ,devices = ,pati5ts ,act ( #bjae4 #b4 ,exp$it$ developm5t ( & priority review = break?r\gh devices 7a7 ,9 g5]al ,*apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is am5d$ by ins]t+ aft] section #eae;,a ! foll[+3 #eae;,b4 ,exp$it$ developm5t ( & priority review = break?r\gh devices 7a7 ,9 g5]al ,9 ord] to provide = m effective treatm5t or diagnosis ( life-?reat5+ or irrev]sibly debilitat+ human disease or conditions1 ! ,secret>y %all e/abli% a program to exp$ite ! developm5t ( & provide = ! priority review = devices-- 7#a7 repres5t+ break?r\gh te*nologies2 7#b7 = :i* no approv$ alt]natives exi/2 7#c7 (f]+ significant advantages ov] exi/+ approv$ or cle>$ alt]natives1 includ+ ! pot5tial1 comp>$ to exi/+ approv$ 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/ ( pati5ts4 7b7 ,reque/ = designation ,a sponsor ( a device may reque/ t ! ,secret>y designate ! device = exp$it$ developm5t & priority review "u ?is section4 ,any su* reque/ = designation may be made at any "t prior to ! submission ( an application "u section #eae7;c71 a petition = classification "u section #eac7;f77#b71 or a notification "u section #eaj7k74 7c7 ,designation ,process 7#a7 ,9 g5]al ,n lat] ?an #fj cal5d> days aft] ! receipt ( a reque/ "u subsection 7b71 ! ,secret>y %all det]m9e :e!r ! device t is ! subject ( ! reque/ meets ! crit]ia describ$ 9 subsection 7a74 ,if ! ,secret>y det]m9es t ! device meets ! crit]ia1 ! ,secret>y %all designate ! device = exp$it$ developm5t & priority review4 7#b7 ,review ,review ( a reque/ "u subsection 7b7 %all be und]tak5 by a team t is compos$ ( exp]i5c$ /aff & manag]s ( ! ,food & ,drug ,adm9i/ration & is *air$ by a s5ior manag]4 7#c7 ,)drawal ,! ,secret>y may n )draw a designation grant$ "u ?is section on ! basis ( ! crit]ia "u subsection 7a7 no long] apply+ because ( ! subsequ5t cle>ance or approval ( ano!r device t-- 7,a7 0 designat$ "u ?is section2 or 7,b7 0 giv5 priority review "u section #eae7;d77#e71 z 9 effect prior to ! date ( enactm5t ( ! ,advanc+ ,break?r\gh ,devices = ,pati5ts ,act ( #bjae4 7d7 ,exp$it$ ,developm5t & ,priority ,review 7#a7 ,actions ,= purposes ( exp$it+ ! developm5t & review ( devices designat$ "u subsection 7c7 ! ,secret>y %all-- 7,a7 assign a team ( /aff1 includ+ a team lead] ) appropriate subject matt] exp]tise & exp]i5ce1 = ea* device = :i* a reque/ is submitt$ "u subsection 7b72 7,b7 provide = ov]sight ( ! team by s5ior ag5cy p]sonnel to facilitate ! effici5t developm5t ( ! device & ! effici5t review ( any submission describ$ 9 subsection 7b7 = ! device2 7,c7 adopt an effici5t process = timely dispute resolution2 7,d7 provide = int]active & timely communication ) ! sponsor ( ! device dur+ ! developm5t program & review process2 7,e7 exp$ite ! ,secret>y's review ( manufactur+ & quality sy/ems compliance1 z applicable2 7,f7 disclose to ! sponsor n less ?an #e bus9ess days 9 advance ! topics ( any consultation ! ,secret>y int5ds to und]take ) ext]nal exp]ts or an advisory committee conc]n+ ! sponsor's device & provide ! sponsor ! opportunity to recomm5d su* ext]nal exp]ts2 7,g7 provide = advisory committee input1 z ! ,secret>y det]m9es appropriate 7includ+ 9 response to ! reque/ ( ! sponsor7 = applications submitt$ "u section #eae7;c72 & 7,h7 assign /aff to be available )9 a reasonable "t to address que/ions by in/itutional review committees conc]n+ ! conditions & cl9ical te/+ requirem5ts applicable to ! inve/igational use ( ! device pursuant to an exemption "u section #ebj7;g74 7#b7 ,additional actions ,9 addition to ! actions describ$ 9 p>agraph 7#a71 = purposes ( exp$it+ ! developm5t & review ( devices designat$ "u subsection 7c71 ! ,secret>y1 9 collaboration ) ! device sponsor1 may1 z appropriate-- 7,a7 coord9ate ) ! sponsor reg>d+ e>ly agreem5t on a data developm5t plan2 7,b7 take /eps to ensure t ! design ( cl9ical trials is z effici5t z practicable1 :5 sci5tifically appropriate1 su* z ?r\gh adoption ( %ort] or small] cl9ical trials1 application ( surrogate endpo9ts1 & ! use ( adaptive trial designs & ,bayesian /ati/ics1 to ! ext5t sci5tifically appropriate2 7,c7 facilitate1 :5 sci5tifically appropriate1 exp$it$ & effici5t developm5t & review ( ! device ?r\gh utilization ( timely po/-m>ket data collection ) reg>d to application = approval "u section #eae7;c72 & 7,d7 agree 9 writ+ to cl9ical protocols t ! ,secret>y w consid] b9d+ on ! ,secret>y & ! sponsor1 subject to-- 7i7 *anges to su* protocols agre$ to 9 writ+ by ! sponsor & ! ,secret>y2 or 7ii7 a decision1 made by ! director ( ! (fice responsible = review+ ! device submission1 t a sub/antial sci5tific issue ess5tial to det]m9+ ! safety or effectiv5ess ( su* device exi/s1 provid$ t su* decision is 9 writ+1 & is made only aft] ! ,secret>y provides to ! device sponsor or applicant an opportunity = a meet+ at :i* ! director & ! sponsor or applicant are pres5t & at :i* ! director docum5ts ! sub/antial sci5tific issue4 7e7 ,priority ,review ,guidance 7#a7 ,cont5t ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,advanc+ ,break?r\gh ,devices = ,pati5ts ,act ( #bjae1 ! ,secret>y %all issue guidance on ! implem5tation ( ?is section4 ,su* guidance %all-- 7,a7 set =? ! process by :i* a p]son may seek a designation "u subsection 7c72 7,b7 provide a template = reque/s "u subsection 7b72 7,c7 id5tify ! crit]ia ! ,secret>y w use 9 evaluat+ a reque/ = designation "u ?is section2 & 7,d7 id5tify ! /&>ds ! ,secret>y w use 9 assign+ a team ( /aff1 includ+ team lead]s1 to review devices 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 a propos$ guidance4 7f7 ,con/ruction 7#a7 ,purpose ,?is section is int5d$ to enc\rage ! ,secret>y & provide ! ,secret>y suffici5t au?orities to apply effici5t & flexible approa*es to exp$ite ! developm5t (1 & prioritize ! ,food & ,drug ,adm9i/ration's review (1 devices t repres5t break?r\gh devices4 7#b7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to affect-- 7,a7 ! crit]ia & /&>ds = evaluat+ an application pursuant to section #eae7;c71 a report & reque/ = classification "u section #eac7;f77#b71 or a report "u section #eaj7k71 includ+ ! recognition ( valid sci5tific evid5ce z describ$ 9 section #eac7;a77#c77;,b7 & consid]ation & application ( ! lea/ burd5some means ( evaluat+ device effectiv5ess or demon/rat+ sub/antial equival5ce betwe5 devices ) diff]+ te*nological *>act]i/ics1 z applicable2 7,b7 ! au?ority ( ! ,secret>y ) respect to cl9ical holds "u section #ebj7;g77#h77;,a72 or 7,c7 ! au?ority ( ! ,secret>y to act on an application pursuant to section #eae7;d7 be=e completion ( an e/abli%m5t inspection1 z ! ,secret>y det]m9es appropriate4 4 7b7 ,docum5tation & review ( significant decisions ,section #eag;,a7a77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;g-#a7;a77#a77 is am5d$ by ins]t+ a reque/ = designation "u section #eae;,b1 aft] application "u section #eae14 7c7 ,t]m9ation ( previ\s program 7#a7 ,9 g5]al ,section #eae7;d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e7d77 is am5d$-- 7,a7 by /rik+ p>agraph 7#e72 & 7,b7 by r$esignat+ p>agraph 7#f7 z p>agraph 7#e74 7#b7 ,con=m+ am5dm5t ,section #gcg7e7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetics ,act 7#ba ,u4,s4,c4 #cgi;i7#e77 is am5d$ by /rik+ #eae7;d77#f7 & ins]t+ #eae7;d77#e74