,i  #aaf? ,,congress  #a/ ,session  ,h4 
,r4 #biae  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,may #bb1 #bjai,mr4   
,fitzpatrick 7= himself1 ,mr4 ,doggett1 
,ms4 ,de,lauro1 & ,ms4 ,s*ak[sky7       
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,en]gy & ,comm]ce  ,a  
,,bill  ,to am5d ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act to require physicians &
 physician's (fices to be treat$ z cov]$
 device us]s requir$ to report on c]ta9 
adv]se ev5ts involv+ m$ical devices1 & =
 o!r purposes4  #a4 ,%ort title ,?is    
,act may be cit$ z ! ,m$ical ,device    
,gu>dians ,act4  #b4 ,report+ by        
physicians & physician's (fices on c]ta9
 adv]se ev5ts involv+ m$ical devices    
7a7 ,ext5d+ requirem5ts ,to apply to    
physicians & physician's (fices         
,subp>agraph 7,a7 ( section #eai7;b77#f7
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4 #cfj;i7b77#f77 is   
am5d$ to read z foll[s3  7,a7 ,! t]m    
cov]$ device us] means a hospital1      
ambulatory surgical facility1 nurs+     

home1 outpati5t treatm5t facility1      
physician1 or physician's (fice4 ,!     
,secret>y may by regulation include an  
outpati5t diagno/ic facility4  4  7b7   
,con=m+ am5dm5ts ,section #eai ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cfj;i7 is am5d$-- 7#a7 9
 subsection 7b7--  7,a7 by /rik+ device 
us] facility ea* place x appe>s & ins]t+
 cov]$ device us]2  7,b7 by /rik+ !     
facility ea* place x appe>s & ins]t+ !  
us]1 except 9 ! phrase ! facility1      
individual1 or physician 9 ! matt]      
foll[+ subp>agraph 7,c7 9 p>agraph 7#c72
  7,c7 9 p>agraph 7#a77;,d71 by /rik+ t 
facility & ins]t+ t us]2  7,d7 9        
p>agraph 7#c77;,b71 by /rik+ su* a      
facility & ins]t+ su* a us]2 &  7,e7 9  
p>agraph 7#e7-- 7i7 by /rik+ device us] 
facilities & ins]t+ cov]$ device us]s2  
7ii7 by /rik+ ( us] facilities & ins]t+ 
( us]s2 &  7iii7 by /rik+ a us] facility
 & ins]t+ a us]2  7#b7 9 subsection     
7b77#c7-- 7,a7 9 subp>agraph 7,a71 by   
add+ or at ! end2  7,b7 9 subp>agraph   

7,b71 by /rik+ or at ! end2 &  7,c7 by  
/rik+ subp>agraph 7,c72 &  7#c7 9       
subsection 7e77#a77;,b77ii71 by /rik+   
outside a device us] facility & ins]t+  
by a p]son o!r ?an a cov]$ device us] 7z
 def9$ 9 subsection 7b774  7c7          
,applicability ,! am5dm5ts made by ?is  
section apply beg9n+ on ! date t is #c  
ye>s aft] ! date ( enactm5t ( ?is ,act4 
#c4 ,electronic sy/em to facilitate     
report+ by cov]$ device us]s  7a7 ,9    
g5]al ,section #eai7;b7 ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfj;i7b771 z am5d$ by section
 #b1 is fur!r am5d$--  7#a7 by          
r$esignat+ p>agraph 7#f7 z p>agraph     
7#g72 &  7#b7 by ins]t+ aft] p>agraph   
7#e7 ! foll[+ new p>agraph3  7#f7 ,!    
,secret>y %all e/abli% & op]ate an      
electronic report+ sy/em to facilitate  
compliance ) ?is subsection by cov]$    
device us]s :o *oose to use su* sy/em to
 submit reports pursuant to ?is         
subsection4  4  7b7 ,comm5cem5t ,n lat] 
?an #c ye>s aft] ! date ( enactm5t ( ?is

 ,act1 ! ,secret>y ( ,heal? & ,human    
,s]vices1 act+ ?r\gh ! ,commission] (   
,food & ,drugs1 %all comm5ce op]ation ( 
! electronic report+ sy/em requir$ by   
section #eai7;b77#f7 ( ! ,f$]al ,food1  
,drug1 & ,cosmetic ,act1 z add$ by      
subsection 7a74  #d4 ,public            
availability ( reports ,section #eai ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cfj;i7 is am5d$ by add+ 
at ! end ! foll[+ new subsection3  7j7  
,public availability ( reports  7#a7 ,9 
g5]al ,not)/&+ any exemption = )hold+   
in=mation "u section #eeb ( title #e1   
,unit$ ,/ates ,code1 b subject to       
p>agraph 7#b71 ! ,secret>y %all make    
reports submitt$ "u ?is section publicly
 available on ! website ( ! ,dep>tm5t ( 
,heal? & ,human ,s]vices4  7#b7         
,individually id5tifiable pati5t        
in=mation ,p>agraph 7#a7 does n require 
! ,secret>y to make publicly available  
any individually id5tifiable pati5t     
in=mation4  4