,i #aag? ,,congress #b;d ,session ,h4 ,r4 #gfdf ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,may #c1 #bjbb,mr4 ,gu?rie 7= himself & ,mr4 ,m\lton7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act to notify ! public ab\t an em]g+ signal conc]n+ a m$ical device 9 ord] to r$uce or limit ! numb] ( pati5ts expos$ to a pot5tial risk id5tifi$ bas$ on su* em]g+ signal1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,em]g+ ,signals ,mod]nization ,act ( #bjbb4 #b4 ,public notification ( an em]g+ signal conc]n+ a m$ical device 7a7 ,te*nical am5dm5ts ,section #eah ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;h7 is am5d$-- 7#a7 by /rik+ ! section designation & head+ & t foll[s ?r\gh ,if ! ,secret>y det]m9es t-- & ins]t+ ! foll[+3 #eah4 ,notification & o!r rem$ies 7a7 ,notification 7#a7 ,9 g5]al ,if ! ,secret>y det]m9es t-- 2 & 7#b7 9 subsection 7a7-- 7,a7 by /rik+ 7#a7 a device & ins]t+ ! foll[+3 7,a7 a device 2 7,b7 by /rik+ 7#b7 notification & ins]t+ ! foll[+3 7,b7 notification 2 7,c7 by mov+ ! m>g9 ( ! cont9uation text at ! end ( subsection 7a7 #b ems to ! "r2 & 7,d7 by /rik+ ?is subsection ea* place x appe>s & ins]t+ ?is p>agraph4 7b7 ,em]g+ signals ,section #eah7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;h7a771 z am5d$ by subsection 7a71 is fur!r am5d$ by add+ at ! end ! foll[+3 7#b7 ,em]g+ signals & o!r notifications 7,a7 ,applicability ,?is p>agraph applies if ! ,secret>y-- 7i7 det]m9es t a device meets ! conditions describ$ 9 p>agraph 7#a77;,a71 & no m practicable means is available "u ! provisions ( ?is ,act1 includ+ p>agraph 7#a71 to elim9ate ! risk describ$ 9 p>agraph 7#a77;,a72 or 7ii7 o!rwise det]m9es t x is necess>y to notify ! public ab\t an em]g+ signal conc]n+ a device 9 ord] to r$uce or limit ! numb] ( pati5ts expos$ to a pot5tial risk id5tifi$ bas$ on an em]g+ signal4 7,b7 ,def9ition ( em]g+ signal ,9 ?is p>agraph1 ! t]m em]g+ signal means new in=mation ab\t a m>ket$ device-- 7i7 t supports a new causal association or a new aspect ( a kn[n association betwe5 ! device & an adv]se ev5t or set ( adv]se ev5ts2 & 7ii7 = :i* ! ,secret>y has conduct$ an initial evaluation & det]m9$ t ! in=mation has ! pot5tial to impact pati5t managem5t decisions or ! kn[n b5efit-risk pr(ile ( ! device4 7,c7 ,reliance on sci5tific evid5ce ,9 consid]+ & tak+ actions "u ?is section1 ! ,secret>y %all-- 7i7 to ! ext5t possible1 rely solely on valid sci5tific evid5ce2 & 7ii7 9 any ev5t1 base su* actions on cr$ible sci5tific evid5ce1 su* t in=mation t is unconfirm$1 unreliable1 or lacks suffici5t /r5g? ( evid5ce %all n con/itute an em]g+ signal or o!rwise provide a basis = notification "u ?is p>agraph4 7,d7 ,cont5t ( public notification ,any public notification "u ?is p>agraph %all-- 7i7 include a description ( ! device or devices to :i* ! notification applies2 7ii7 reflect a totality ( ! evid5ce on :i* ! notification is bas$2 & 7iii7 incorporate in=mation ab\t ! kn[n b5efits & risks ( ! device or devices1 includ+ in=mation available f ! manufactur] or manufactur]s4 7,e7 ,contradictory evid5ce ,to ! ext5t cr$ible sci5tific evid5ce is pres5t$ to ! ,secret>y t contradicts or modifies ! in=mation t s]ves z a pot5tial basis = a public notification "u ?is p>agraph1 ! ,secret>y %all include su* sci5tific evid5ce 9 ! public notification 9 a mann] t provides ! int5d$ audi5ce ) a complete und]/&+ ( ! ov]all nature ( in=mation conc]n+ ! pot5tial risk4 7,f7 ,opportunity = manufactur]s to comm5t ,prior to issuance ( a public notification "u ?is p>agraph1 ! ,secret>y %all-- 7i7 provide ! manufactur] or manufactur]s ( ! device or devices at issue ! cr$ible sci5tific evid5ce t is ! basis = consid]+ ! public notification & ! ,secret>y's initial evaluation ( su* evid5ce z describ$ 9 subp>agraph 7,b77ii72 7ii7 to ! ext5t ! ,secret>y det]m9es t any ( ! cr$ible sci5tific evid5ce describ$ 9 clause 7i7 _c be provid$ to manufactur]s because su* evid5ce con/itutes confid5tial comm]cial in=mation or trade secret in=mation1 provide ! manufactur] or manufactur]s ( ! device or devices at issue ) a description ( ! )held evid5ce to ! ext5t p]missible by law & g5]ally describe ! basis = )hold+ su* evid5ce2 7iii7 provide ! manufactur] or manufactur]s ( ! device or devices at issue an adequate opportunity-- 7,i7 to comm5t z to ! nature ( ! pot5tial risk & ! mann] & cont5t ( ! pot5tial notification "u ?is p>agraph2 7,,ii7 to %>e in=mation ab\t ! pot5tial risk2 & 7,,iii7 to (f] recomm5dations z to ! =m & cont5t ( ! pot5tial notification1 includ+ consid]ation ( alt]native =ms ( notification & risk mitigation2 & 7iv7 consid] any input receiv$ "u clause 7iii74 7,g7 ,updates ,! ,secret>y %all provide p]iodic & timely updates to ea* notification "u ?is p>agraph bas$ on new in=mation or contr>y in=mation1 includ+ affirmative notice 9 ! ev5t t ! em]g+ signal or o!r s\rce ( pot5tial risk has be5 det]m9$ n to apply or has o!rwise be5 resolv$ or mitigat$1 su* t no additional actions are requir$4 ,= purposes ( provid+ updates "u ?is subp>agraph1 ! ,secret>y %all consid] in=mation provid$ to ! ,secret>y by a manufactur] subsequ5t to ! initial public notification4 7,h7 ,response to in=mation provid$ by manufactur] ,) reg>d to in=mation provid$ to ! ,secret>y by a manufactur] relat+ to a notification "u ?is p>agraph1 ! ,secret>y %all in=m su* manufactur]-- 7i7 h[ su* in=mation affects or alt]s ! ,secret>y's initial evaluation2 & 7ii7 :e!r ! notification w be updat$ or resc9d$ z a result ( su* in=mation4 7,i7 ,p]iodic evaluation ,at lea/ e six mon?s aft] issuance ( a notification "u ?is p>agraph1 ! ,secret>y %all-- 7i7 evaluate curr5t cr$ible sci5tific evid5ce to det]m9e if su* notification %\ld be resc9d$2 & 7ii7 if ! ,secret>y det]m9es su* notification %\ld be resc9d$1 promptly provide notice ( ! rescission to ! same audi5ce & 9 ! same mann] z ! orig9al notification4 7,j7 ,revision ( guidance ,n lat] ?an ,septemb] #cj1 #bjbc1 ! ,secret>y %all revise ! guidance ( ! ,food & ,drug ,adm9i/ration titl$ ,public ,notification ( ,em]g+ ,po/m>ket ,m$ical ,device ,signals 7,em]g+ ,signals71 to con=m ) ?is p>agraph4 7,k7 ,report to ,congress ,n lat] ?an ,septemb] #cj1 #bjbc1 ! ,secret>y %all submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report reg>d+-- 7i7 h[ pati5ts1 heal? c>e provid]s1 & ! public int]pret & compreh5d risk-relat$ in=mation provid$ or ord]$ by ! ,secret>y relat+ to devices1 includ+ reports "u ?is section1 notifications conc]n+ recalls1 & notifications conc]n+ adv]se ev5ts2 & 7ii7 :e!r ! relative level ( risk & appropriate mitigations = su* risk are adequately und]/ood4 7,l7 ,?ird p>ty data transp>5cy ,to ! ext5t ! ,secret>y seeks to rely on data1 analysis1 or o!r in=mation or f9d+s provid$ by ?ird p>ties t has be5 fund$ 9 :ole or 9 "p by1 or o!rwise p]=m$ "u contract )1 ! ,food & ,drug ,adm9i/ration1 9 mak+ a significant decision conc]n+ "o or m devices or consid]+ issuance ( an ord] "u ?is section or section #ebb1 ! ,secret>y %all-- 7i7 obta9 access to ! raw datasets1 inputs1 cl9ical or o!r assumptions1 me?ods1 analytical code1 results1 & o!r compon5ts und]ly+ or compris+ ! data1 analysis1 or o!r in=mation or f9d+s ^u :i* ! ,secret>y seeks to rely2 & 7ii7 if su* a significant decision is made1 or su* an ord] "u ?is section or section #ebb is "u consid]ation1 9 reliance on su* data1 analysis1 or o!r in=mation or f9d+s1 provide ! manufactur] or manufactur]s subject to su* decision or ord] ! data1 analysis1 or o!r in=mation or f9d+s1 includ+ ! und]ly+ raw datasets1 inputs1 cl9ical or o!r assumptions1 me?ods1 analytical code1 results1 & o!r compon5ts1 except t any su* raw datasets1 inputs1 cl9ical or o!r assumptions1 me?ods1 analytical code1 results1 & o!r compon5ts t ! ,secret>y det]m9es to be confid5tial comm]cial in=mation or trade secret in=mation may be )held b %all be describ$ to ! manufactur] or manufactur]s to ! ext5t p]missible by law4 4