,,ii #aae? ,,congress #a/ ,session ,s4 #ajic ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,may #aj1 #bjag ,mr4 ,frank5 7= himself & ,mr4 ,enzi7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act to improve p$iatric m$ical device application proc$ures4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,p$iatric ,device ,developm5t ,act4 #b4 ,p$iatric uses ( devices ,section #eae;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e-#a7 is am5d$-- 7#a7 9 subsection 7a77#c7-- 7,a7 by r$esignat+ subp>agraphs 7,b7 ?r\gh 7,d7 z subp>agraphs 7,d7 ?r\gh 7,f71 respectively2 7,b7 by ins]t+ aft] subp>agraph 7,a7 ! foll[+3 7,b7 an assessm5t ( p$iatric device label+ ne$s1 bas$ on a review ( real _w evid5ce on ! (f-label use ( m$ical devices 9 *ildr51 drawn f data available to ! ,food & ,drug ,adm9i/ration2 7,c7 ! numb] ( devices t receive a humanit>ian use exemption "u section #ebj7m72 2 7,c7 9 subp>agraph 7,e7 7z s r$esignat$71 by /rik+ 2 & & ins]t+ 22 7,d7 9 subp>agraph 7,f7 7z s r$esignat$71 by /rik+ 7,b71 & 7,c74 & ins]t+ 7,c71 7,d71 & 7,e72 &2 & 7,e7 by add+ at ! end ! foll[+3 7,g7 ! numb] ( devices = :i* extrapolation 0 us$ to support ! approval ( p$iatric label+ ( su* devices4 ,= ! items describ$ 9 ?is p>agraph1 su* report %all disaggregate ! numb] ( devices by p$iatric subpopulation4 2 7#b7 by r$esignat+ subsection 7c7 z subsection 7d72 & 7#c7 by ins]t+ aft] subsection 7b71 ! foll[+3 7c7 ,p$iatric device innovation 7#a7 ,9 g5]al ,! ,secret>y %all1 n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,p$iatric ,device ,developm5t ,act1 e/abli% )9 ! ,c5t] = ,devices & ,radiological ,heal? a /ructure to-- 7,a7 provide assi/ance to device manufactur]s1 9 coord9ation ) ! relevant review committees1 z appropriate1 t w\ld result 9 ! developm5t1 approval1 & label+ ( m$ical devices = *ildr52 7,b7 ov]see an int]nal p$iatrics team t-- 7i7 is compris$ (-- 7,i7 employees ( ! ,food & ,drug ,adm9i/ration ) exp]tise 9 p$iatrics & appropriate exp]tise p]ta9+ to ! relevant devices "u review2 & 7,,ii7 o!r individuals designat$ by ! ,secret>y2 & 7ii7 provides exp]tise & consultation on-- 7,i7 ! application ( subsection 7b71 section #ebj7m71 section #eaj7k71 & section #ebb ( ?is ,act & section #djb ( ! ,public ,heal? ,s]vice ,act to p$iatric devices2 & 7,,ii7 p$iatrics1 z x p]ta9s to review+ devices1 to all applicable divisions )9 ! ,c5t] = ,devices & ,radiological ,heal?2 7,c7 coord9ate p$iatric activities )9 ! ,c5t] = ,devices & ,radiological ,heal?2 & 7,d7 collaborate ) o!r programs1 (fices1 & c5t]s ( ! ,food & ,drug ,adm9i/ration1 includ+ ! consortia program au?oriz$ "u section #cje ( ! ,p$iatric ,m$ical ,device ,safety & ,improvem5t ,act ( #bjjg4 7#b7 ,/aff ,su* /ructure %all include a *ief p$iatric m$ical (fic] & o!r appropriate individuals z ! ,secret>y det]m9es necess>y4 4 #c4 ,humanit>ian device exemption ,section #ebj7m7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7m77 is am5d$-- 7#a7 9 p>agraph 7#d7-- 7,a7 by /rik+ an in/itutional review committee ea* place su* t]m appe>s & ins]t+ an in/itutional review bo>d or an appropriate local committee2 & 7,b7 by /rik+ ! in/itutional review committee & ins]t+ ! in/itutional review bo>d or ! appropriate local committee2 & 7#b7 9 p>agraph 7#f77;,a77iv71 by /rik+ #bjag & ins]t+ #bjbb4 #d4 ,demon/ration grants = improv+ p$iatric availability ,section #cje ( ! ,p$iatric ,m$ical ,device ,safety & ,improvem5t ,act ( #bjjg 7,public ,law #aaj-he2 #db ,u4,s4,c4 #bhb note7 is am5d$-- 7#a7 9 subsection 7c7-- 7,a7 9 p>agraph 7#d71 by /rik+ & at ! end2 7,b7 9 p>agraph 7#e71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7,c7 by add+ at ! end ! foll[+3 7#f7 provid+ regulatory consultation to device sponsors 9 support ( ! submission ( an application = a p$iatric device1 :]e appropriate4 2 & 7#b7 9 subsection 7e71 by /rik+ #bjag & ins]t+ #bjbb4 #e4 ,meet+ on p$iatric device developm5t 7a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all conv5e a public meet+ reg>d+ opportunities & b>ri]s to ! developm5t1 approval1 & label+ ( p$iatric m$ical devices4 ,su* meet+ %all include repres5tatives f ! m$ical device indu/ry1 academia1 recipi5ts ( fund+ "u section #cje ( ! ,p$iatric ,m$ical ,device ,safety & ,improvem5t ,act ( #bjjg 7,public ,law #aaj-he2 #db ,u4,s4,c4 #bhb note71 m$ical provid] organizations1 & organizations repres5t+ pati5ts & consum]s4 7b7 ,topics ,! meet+ describ$ 9 subsection 7a7 %all include consid]ation ( ways to-- 7#a7 improve rese>* infra/ructure & rese>* networks to facilitate ! conduct ( cl9ical /udies ( devices = *ildr5 t w\ld result 9 ! approval & label+ ( m$ical devices = *ildr52 7#b7 appropriately use extrapolation "u section #eae;,a7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e-#a7;b772 7#c7 enhance ! appropriate use ( po/m>ket regi/ries & data to increase p$iatric m$ical device label+2 7#d7 increase ,food & ,drug ,adm9i/ration assi/ance to m$ical device manufactur]s 9 develop+ devices = *ildr5 t are approv$ & label$ = _! use2 & 7#e7 id5tify curr5t b>ri]s to p$iatric device developm5t & inc5tives to address su* b>ri]s4 7c7 ,report ,n lat] ?an #f mon?s aft] ! meet+ describ$ 9 subsection 7a71 ! ,secret>y ( ,heal? & ,human ,s]vices %all submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate1 & publi%1 includ+ on ! ,int]net website ( ! ,food & ,drug ,adm9i/ration1 a report t summ>izes & responds to ! recomm5dations rais$ 9 su* meet+4