,,ii  #aai? ,,congress  #a/ ,session    
,s4 #cdba  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,decemb] #aj1 #bjbe,mr4
 ,durb9 introduc$ ! foll[+ bill2 :i* 0  
read twice & ref]r$ to ! ,committee on  
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to improve m$ical device    
recall notifications by am5d+ ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act to       
e/abli% an electronic =mat = device     
recall notifications1 & = o!r purposes4 
#a4 ,%ort title ,?is ,act may be cit$ z 
! ,m$ical ,device ,recall ,improvem5t   
,act ( #bjbe4  #b4 ,regulation ( m$ical 
device recalls ,*apt] ,v ( ! ,f$]al     
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cea et seq471 is am5d$ by    
ins]t+ aft] section #eah;,a ( su* ,act !
 foll[+3  #eah;,b4 ,electronic          
notification =mat = device recalls  7a7 
,electronic notification =mat = device  
recalls  7#a7 ,9 g5]al ,n lat] ?an #b   
ye>s aft] ! date ( enactm5t ( ! ,m$ical 
,device ,recall ,improvem5t ,act (      
#bjbe1 ! ,secret>y %all publi% a =m &   

mann] = notifications ( a recall4  7#b7 
,cont5t ,! =m & mann] prescrib$ by !    
,secret>y "u p>agraph 7#a7 %all-- 7,a7  
be electronic2  7,b7 include m&atory    
data elem5ts1 includ+-- 7i7 ! "n ( !    
manufactur] or import]2  7ii7 ! contact 
in=mation & address ( ! manufactur] or  
import]2  7iii7 ! specific reason = !   
correction or removal f ! m>ket ( !     
device2  7iv7 ! specific device ( !     
manufactur] or import] subject to su*   
recall2  7v7 ! unique device id5tifi] ( 
! device1 includ+1 z applicable1 !      
device id5tifi] & any production        
id5tifi]2  7vi7 in=mation = device us]  
facilities & heal? pr(essionals ) reg>d 
to ! device & su* recall2 &  7vii7      
in=mation = pati5ts ) reg>d to ! device 
& su* recall1 includ+-- 7,i7 ! risk     
pres5t$ by ! device2 &  7,,ii7 any      
action t may be tak5 by1 or on behalf (1
 su* pati5ts to elim9ate or r$uce su*   
risk2 &  7,c7 include optional data     
elem5ts z ! ,secret>y det]m9es to be    
appropriate4  7b7 ,notifications  7#a7  

,notifications to ! ,secret>y  7,a7 ,9  
g5]al ,beg9n+ #ahj days aft] ! ,secret>y
 e/abli%es ! =m & mann] = recall        
notifications "u subsection 7a71 a      
manufactur] or import] ( a device %all  
submit notifications requir$ "u section 
#eai7;g7 to ! ,secret>y ?r\gh !         
electronic notification =mat e/abli%$ "u
 subsection 7a74  7,b7 ,review          
requirem5t  7i7 ,initial review ,n lat] 
?an #b bus9ess days aft] receipt ( a    
notification describ$ 9 subp>agraph     
7,a71 ! ,secret>y %all conduct an       
initial review ( su* notification4  7ii7
 ,response ( ! ,secret>y ,n lat] ?an #c 
bus9ess days aft] ! completion ( su*    
review1 ! ,secret>y %all in=m !         
manufactur] or import] ( ! in=mation !  
,secret>y det]m9es1 ?r\gh ! initial     
review "u clause 7i71 %\ld be %>$ )     
device us] facilities & heal?           
pr(essionals4  7#b7 ,notifications to   
device us] facilities & heal?           
pr(essionals  7,a7 ,initial             
notifications ,a manufactur] or import] 

%all submit notifications to device us] 
facilities & heal? pr(essionals ?r\gh ! 
electronic notification =mat e/abli%$ "u
 subsection 7a7 aft] an initial review  
by ! ,secret>y is complet$ "u p>agraph  
7#a77;,b77i74  7,b7 ,subsequ5t          
notifications ,a manufactur] or import] 
%all provide notifications 9 addition to
 ^? describ$ 9 subp>agraph 7,a71 z      
necess>y1 to device us] facilities or   
heal? pr(essionals ?r\gh ! electronic   
notification =mat e/abli%$ "u subsection
 7a74  7c7 ,electronic database ,!      
,secret>y %all ma9ta9 an electronic     
database t is publicly accessible1      
d[nloadable1 & populat$ ) in=mation     
reg>d+ device notifications made "u ?is 
section4  7d7 ,def9itions ,9 ?is section
 & 9 section #eah;,c-- 7#a7 ! t]m device
 us] facility has ! mean+ giv5 su* t]m 9
 section #eai7;b77#f72 &  7#b7 ! t]m    
recall has ! mean+ giv5 su* t]m 9       
section #eah;,a4  7e7 ,au?orization (   
appropriations ,= purposes ( conduct+   
activities "u ?is section & hir+        

p]sonnel to conduct su* activities1 !re 
is au?oriz$ to be appropriat$ #f1gjj1jjj
 = fiscal ye> #bjbf1 #a1gjj1jjj = fiscal
 ye> #bjbg1 & #a1jjj1jjj = ea* ( fiscal 
ye>s #bjbh ?r\gh #bjcj1 to rema9        
available until exp5d$1 )\t fiscal ye>  
limitation4  #eah;,c4 ,pati5t           
notification  7a7 ,9 g5]al ,! ,secret>y 
%all require t any recall /rategy "u    
section #eai7;g7 provides = notice to   
pati5ts :om device us] facilities &     
heal? pr(essionals treat$ ) ! device4   
7b7 ,compliance ,9 accordance )         
subsection 7a71 ! ,secret>y %all require
 recall notifications s5t f !           
manufactur] or import] ( ! device to--  
7#a7 include in=mation = device us]     
facilities & heal? pr(essionals ab\t !  
risks pres5t$ by ! device to pati5ts :om
 device us] facilities & heal?          
pr(essionals treat$ ) ! device2 &  7#b7 
in/ruct su* device us] facilities &     
heal? pr(essionals to %>e in=mation "u  
p>agraph 7#a7 ) pati5ts :om device us]  
facilities & heal? pr(essionals treat$ )

 ! device4  7c7 ,affect$ devices        
,subsection 7a7 %all apply ) respect to 
any class ,i or class ,,ii recall = a   
class ,,ii or class ,,iii device t is   
us$ outside ( device us] facilities &-- 
7#a7 implant$ 9 ! human body2  7#b7     
life-su/a9+2  7#c7 life-support+2 or    
7#d7 us$ significantly 9 p$iatric       
populations4  7d7 ,rule ( con/ruction   
,no?+ 9 ?is section %all be con/ru$ to  
require device us] facilities or heal?  
pr(essionals to provide pati5t in=mation
 to ! manufactur] or import] ( ! device4
  4  #c4 ,prohibit$ acts ,section #cja (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 7#ba ,u4,s4,c4 #cca7 is am5d$ by add+  
at ! end ! foll[+3  7jjj7 ,! refusal or 
failure to submit notifications 9       
accordance ) p>agraphs 7#a7 & 7#b7 (    
section #eah;,b7b74  7kkk7 ,! refusal or
 failure to provide notice 9 accordance 
) section #eah;,c4  4