,,ii  #aag? ,,congress  #b;d ,session   
,s4 #dcdi  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,june #f1 #bjbb,mr4    
,m>%all 7= himself & ,mr4 ,braun7       
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to am5d ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act ) respect to    
notifications ( em]g+ signals conc]n+   
devices4  #a4 ,notification ) respect to
 pot5tially h>mful devices ,section     
#eah7;a7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;h7a77
 is am5d$ by add+ at ! end ! foll[+3    
7#c7 7,a7 ,?is p>agraph applies 9 ! ev5t
 t ! ,secret>y-- 7i7 det]m9es t a device
 meets ! conditions describ$ 9 p>agraph 
7#a71 b !re are no m practicable means  
available "u ! provisions ( ?is ,act    
7o!r ?an ?is section7 to elim9ate ! risk
 describ$ 9 p>agraph 7#a71 & !          
notification describ$ 9 p>agraph 7#b7 w 
n provide a timely & practicable means  
to elim9ate su* risk2 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 
,= purposes ( ?is p>agraph1 ! t]m em]g+ 
signal mean 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 a 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 ,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 its 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 = notification4  7,d7 ,9

 ! circum/ances describ$ 9 subp>agraph  
7,a71 ! ,secret>y may issue a public    
notification subject to ! foll[+        
proc$ures3 7i7 ,any public notification 
"u ?is p>agraph %all include a          
description ( ! device or devices to :i*
 ! notification applies1 & %all reflect 
a totality ( ! evid5ce on :i* !         
notification is bas$ & in=mation ab\t ! 
kn[n b5efits & risks ( ! device or      
devices1 includ+ in=mation available f !
 manufactur] or manufactur]s4  7ii7 ,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 notification1 !      
,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      
7iii7 ,prior to issuance ( ! public     
notification1 ! ,secret>y %all-- 7,i7   
in=m ! manufactur] or manufactur]s ( !  
device or devices at issue1 & provide ! 

manufactur]s ! cr$ible sci5tific evid5ce
 t is ! basis = consid]+ a public       
notification & ! ,secret>y's initial    
evaluation ( su* evid5ce z describ$ 9   
subp>agraph 7,b77ii72  7,,ii7 to ! ext5t
 ! ,secret>y det]m9es t any ( ! cr$ible 
sci5tific evid5ce describ$ 9 subclause  
7,i7 _c be provid$ to manufactur]s      
because su* evid5ce con/itutes          
confid5tial comm]cial in=mation or trade
 secret in=mation1 ! ,secret>y %all     
provide ! manufactur]s ( ! device or    
devices at issue ) a description ( !    
)held evid5ce to ! ext5t p]missible by  
law & also g5]ally describe ! basis =   
)hold+ su* evid5ce2 &  7,,iii7 provide !
 manufactur]s ( ! device or devices at  
issue an adequate opportunity to comm5t 
z to ! nature ( ! pot5tial risk & !     
mann] & cont5t ( an applicable          
notification1 to %>e in=mation ab\t !   
pot5tial risk1 & to (f] recomm5dations z
 to ! =m & cont5t ( ! propos$           
notification1 includ+ consid]ation (    
alt]native =ms ( notification & risk    

mitigation1 & ! ,secret>y %all consid]  
su* input f ! manufactur]s be=e issu+ a 
public notification4  7iv7 ,provide     
p]iodic & timely updates to !           
notification 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$4 ,in=mation provid$ by      
manufactur]s subsequ5t to ! initial     
public notification %\ld be consid]$ by 
! ,secret>y = purposes ( provid+        
updates4  7v7 ,) reg>d to in=mation     
provid$ by manufactur]s1 ! ,secret>y    
%all in=m su* manufactur]s h[ su*       
in=mation affects or alt]s ! ,secret>y's
 initial evaluation & :e!r !            
notification w be updat$ or resc9d$ z a 
result ( su* in=mation4  7vi7 ,at lea/ e
 #f mon?s aft] issuance1 ! ,secret>y    
%all evaluate curr5t cr$ible sci5tific  
evid5ce to det]m9e if a public          
notification %\ld be resc9d$1 & if su*  

det]m9ation is made1 promptly provide   
notice ( ! rescission to ! same audi5ce 
& 9 ! same mann] z ! orig9al            
notification4  7,e7 ,n lat] ?an         
,septemb] #cj1 #bjbc1 ! ,secret>y %all  
revise ! ,food & ,drug ,adm9i/ration    
guidance titl$ ,public ,notification (  
,em]g+ ,po/m>ket ,m$ical ,device        
,signals 7,em]g+ ,signals71 to con=m )  
?is subsection4  7,f7 ,n lat] ?an       
,septemb] #cj1 #bjbc1 ! ,secret>y %all  
submit to ! ,committee on ,heal?1       
,education1 ,labor1 & ,p5sions ( !      
,s5ate & ! ,committee on ,en]gy &       
,comm]ce ( ! ,h\se ( ,repres5tatives a  
report reg>d+ h[ pati5ts1 provid]s1 & ! 
public int]pret & compreh5d risk-relat$ 
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 ev5ts1 & :e!r ! relative level (
 risk & appropriate mitigation = su*    
risk are adequately und]/ood4  7,g7 ,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/ration 9 mak+ significant        
decisions conc]n+ devices or consid]+   
issuance ( ord]s "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+ !         
analysis1 conclusions or o!r f9d+s ^u   
:i* ! ,secret>y seeks to rely2 &  7ii7 9
 ! ev5t a significant decision is made1 
or an ord] "u ?is section or section    
#ebb is "u consid]ation1 9 reliance on  
su* in=mation or f9d+s1 provide !       
manufactur] or manufactur]s subject to  
su* decision or ord] ! in=mation or     
f9d+s1 includ+ ! und]ly+ in=mation      
describ$ 9 p>agraph 7#a71 except t any  
su* und]ly+ in=mation 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