,i #aad? ,,congress #a/ ,session ,h4 ,r4 #bcif ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,may #ah1 #bjae ,mrs4 ,blackburn 7= h]self & ,mr4 ,g5e ,gre5 ( ,texas7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act ) respect to ! regulation ( heal? s(tw>e1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,s5sible ,ov]sight = ,te*nology :i* ,advances ,regulatory ,effici5cy ,act or ! ,,s(tw>e ,act4 #b4 ,heal? s(tw>e ,section #bja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7 is am5d$ by add+ at ! end ! foll[+3 7ss7 7#a7 ,! t]m heal? s(tw>e means s(tw>e t does n1 ?r\gh use ( an 9 vitro diagno/ic device or signal acquisition sy/em1 acquire1 process1 or analyze an image or physiological signal1 is n an accessory1 is n an integral "p ( a device necess>y to support ! use ( ! device1 is n us$ 9 ! manufacture & transfusion ( blood & blood compon5ts to assi/ 9 ! prev5tion ( disease 9 humans1 &-- 7,a7 is int5d$ = use = adm9i/rative or op]ational support or ! process+ & ma9t5ance ( f9ancial records2 7,b7 is int5d$ = use 9 cl9ical1 laboratory1 or adm9i/rative workfl[ & relat$ recordkeep+2 7,c7 7i7 is int5d$ = use solely 9 ! transf]1 aggregation1 conv]sion 79 accordance ) a pres5t specification71 /orage1 managem5t1 retrieval1 or transmission ( data or in=mation2 7ii7 utilizes a connectivity s(tw>e plat=m1 electronic or electrical h>dw>e1 or a physical communications infra/ructure2 & 7iii7 is n int5d$ = use-- 7,i7 9 active pati5t monitor+2 or 7,,ii7 9 controll+ or alt]+ ! functions or p>amet]s ( a device t is connect$ to su* s(tw>e2 7,d7 is int5d$ = use to organize & pres5t in=mation = heal? or wellness education or = use 9 ma9ta9+ a heal?y life/yle1 includ+ m$ication adh]5ce & heal? managem5t tools2 7,e7 is int5d$ = use to analyze in=mation to provide g5]al heal? in=mation t does n include pati5t-specific recomm5d$ options to consid] 9 ! prev5tion1 diagnosis1 treatm5t1 cure1 or mitigation ( a p>ticul> disease or condition2 or 7,f7 is int5d$ = use to analyze in=mation to provide pati5t-specific recomm5d$ options to consid] 9 ! prev5tion1 diagnosis1 treatm5t1 cure1 or mitigation ( a p>ticul> disease or condition4 7#b7 ,! t]m accessory means a product t-- 7,a7 is int5d$ = use ) "o or m p>5t devices2 7,b7 is int5d$ to support1 supplem5t1 or augm5t ! p]=mance ( "o or m p>5t devices2 & 7,c7 %all be classifi$ by ! ,secret>y-- 7i7 accord+ to its int5d$ use2 & 7ii7 indep5d5tly ( any classification ( any p>5t device ) :i* x is us$4 4 #c4 ,applicability & inapplicability ( regulation ,sub*apt] ,a ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is am5d$ by add+ at ! end ! foll[+3 #ebd;,b4 ,heal? s(tw>e 7a7 ,inapplicability ( regulation to heal? s(tw>e ,except z provid$ 9 subsection 7b71 heal? s(tw>e %all n be subject to regulation "u ?is ,act4 7b7 ,exception 7#a7 ,9 g5]al ,subsection 7a7 %all n apply ) respect to a s(tw>e product-- 7,a7 ( a type describ$ 9 subp>agraph 7,f7 ( section #bja7ss77#a72 & 7,b7 t ! ,secret>y det]m9es poses a significant risk to pati5t safety4 7#b7 ,consid]ations ,9 mak+ a det]m9ation "u subp>agraph 7,b7 ( p>agraph 7#a7 ) respect to a product to :i* su* p>agraph applies1 ! ,secret>y %all consid] ! foll[+3 7,a7 ,! likelihood & sev]ity ( pati5t h>m if ! product 7 to n p]=m z int5d$4 7,b7 ,! ext5t to :i* ! product is int5d$ to support ! cl9ical judgm5t ( a m$ical pr(essional4 7,c7 ,:e!r !re is a reasonable opportunity = a m$ical pr(essional to review ! basis ( ! in=mation or treatm5t recomm5dation provid$ by ! product4 7,d7 ,! int5d$ us] & us] environm5t1 su* z :e!r a m$ical pr(essional w use a s(tw>e product ( a type describ$ 9 subp>agraph 7,f7 ( section #bja7ss77#a74 7c7 ,delegation ,! ,secret>y %all delegate prim>y jurisdiction = regulat+ a s(tw>e product det]m9$ "u subsection 7b7 to be subject to regulation "u ?is ,act to ! c5t] at ! ,food & ,drug ,adm9i/ration *>g$ ) regulat+ devices4 7d7 ,regulation ( s(tw>e 7#a7 ,9 g5]al ,! ,secret>y %all review exi/+ regulations & guidance reg>d+ ! regulation ( s(tw>e "u ?is ,act4 ,! ,secret>y may implem5t a new framework = ! regulation ( s(tw>e & %all1 z appropriate1 modify su* regulations & guidance or issue new regulations or guidance4 7#b7 ,issuance by ord] ,not)/&+ sub*apt] ,,ii ( *apt] #e ( title #e1 ,unit$ ,/ates ,code1 ! ,secret>y may modify or issue regulations = ! regulation ( s(tw>e "u ?is ,act by adm9i/rative ord] publi%$ 9 ! ,f$]al ,regi/] foll[+ ! publication ( a propos$ ord]4 7#c7 ,areas "u review ,! review ( exi/+ regulations & guidance "u p>agraph 7#a7 may include review ( ! foll[+ areas3 7,a7 ,classification ( s(tw>e4 7,b7 ,/&>ds = developm5t ( s(tw>e4 7,c7 ,/&>ds = validation & v]ification ( s(tw>e4 7,d7 ,review ( s(tw>e4 7,e7 ,modifications to s(tw>e4 7,f7 ,manufactur+ ( s(tw>e4 7,g7 ,quality sy/ems = s(tw>e4 7,h7 ,label+ requirem5ts = s(tw>e4 7,i7 ,po/m>ket+ requirem5ts = report+ ( adv]se ev5ts4 7#d7 ,process = issu+ propos$ regulations1 adm9i/rative ord]1 & guidance ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is section1 ! ,secret>y %all consult ) ext]nal /akehold]s 7includ+ pati5ts1 indu/ry1 heal? c>e provid]s1 academia1 & gov]nm5t7 to ga!r input be=e issu+ regulations1 an adm9i/rative ord]1 & guidance "u ?is subsection4 7e7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ z provid+ ! ,secret>y ) ! au?ority to regulate "u ?is ,act any heal? s(tw>e product ( ! type describ$ 9 subp>agraph 7,f7 ( section #bja7ss77#a7 unless & until ! ,secret>y has made a det]m9ation describ$ 9 subsection 7b77#a77;,b7 ) respect to su* product4 4 #d4 ,exclusion f def9ition ( device ,section #bja7;h7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7 is am5d$-- 7#a7 9 subp>agraph 7#b71 by /rik+ or aft] or o!r animals12 7#b7 9 subp>agraph 7#c71 by /rik+ & & ins]t+ or2 & 7#c7 by ins]t+ aft] subp>agraph 7#c7 ! foll[+3 7#d7 is n heal? s(tw>e 7o!r ?an s(tw>e det]m9$ to be a risk to pati5t safety "u section #ebd;,b7b771 & 4