,i  #aae? ,,congress  #a/ ,session  ,h4 
,r4 #bafc  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,april #bf1 #bjag,mr4 
,fitzpatrick 7= himself1 ,ms4 ,slaught]1
 & ,ms4 ,de,lauro7 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]2   
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