,i  #aae? ,,congress  #a/ ,session  ,h4 
,r4 #baah  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,april #be1 #bjag,mr4 
,co/ello ( ,p5nsylvania 7= himself &    
,mr4 ,pet]s7 introduc$ ! foll[+ bill2   
:i* 0 ref]r$ to ! ,committee on ,en]gy &
 ,comm]ce  ,a ,,bill  ,to am5d ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act to       
require ! regi/ration ( e/abli%m5ts t   
s]vice devices1 & = o!r purposes4  #a4  
,%ort title ,?is ,act may be cit$ z !   
,m$ical ,device ,s]vic+ ,safety &       
,acc\ntability ,act4  #b4 ,regi/ration (
 s]vic]s ( devices  7a7 ,9 g5]al        
,section #eaj ( ! ,f$]al ,food1 ,drug1 &
 ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7 is 
am5d$ by add+ at ! end ! foll[+3  7r7   
,regi/ration ( ,s]vic+ ,e/abli%m5ts2    
,compla9t ,h&l+  7#a7 ,9 g5]al ,!       
,secret>y %all1 n lat] ?an #ah mon?s    
aft] ! date ( ! enactm5t ( ?is          
subsection1 issue f9al regulations      
requir+ any p]son :o owns or op]ates any
 e/abli%m5t 9 any ,/ate engag$ 9 !      
s]vic+ ( a device or devices1 or is     

o!rwise engag$ 9 ! s]vic+ ( a device or 
devices1 to regi/] ) ! ,secret>y4 ,su*  
regulations %all--  7,a7 specify ! tim+1
 =mat1 & in=mation to be submitt$ by any
 su* p]son2  7,b7 require t su* a p]son 
e/abli% a compla9t h&l+ sy/em equival5t 
to a sy/em meet+ ! requirem5ts ( section
 #hbj4aih ( title #ba1 ,code ( ,f$]al   
,regulations 7or successor regulations72
 &  7,c7 provide = an exemption f su*   
regi/ration t-- 7i7 applies to s]vic+   
op]ations conduct$ by a device us]      
facility 7z def9$ 9 section             
#eai7;b77#f771 or a physician (fice     
op]at+ 9 accordance ) any applicable    
,/ate or local laws2 &  7ii7 does n     
apply to device s]vic+ op]ations        
conduct$ by p]sons :o contract ) device 
us] facilities or physician (fices to   
s]vice devices4  7#b7 ,s]vic+ def9$ ,9  
?is subsection1 ! t]m s]vic+ includes1 )
 respect to a device1 refurbi%+1        
recondition+1 rebuild+1 rem>ket+1       
repair+1 or o!r s]vic+ ( ! device by a  
p]son o!r ?an ! manufactur] ( ! device4 

4  7b7 ,reports by s]vic]s  7#a7 ,9     
g5]al ,section #eai7;a7 ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfj;i7a77 is am5d$-- 7,a7 by 
/rik+ manufactur] or import] ea* place x
 appe>s & ins]t+ manufactur]1 s]vic]1 or
 import]2  7,b7 by add+ at ! end !      
foll[+3  7#i7 ,9 ?is subsection1 ! t]m  
s]vic] means any p]son :o is engag$ 9   
s]vic+ 7z su* t]m is def9$ 9 subsection 
7r7 ( section #eaj77 & requir$ to regi/]
 ) ! ,secret>y "u su* subsection4  4    
7#b7 ,regulations ,n lat] ?an #ah mon?s 
aft] ! date ( ! enactm5t ( ?is ,act1 !  
,secret>y ( ,heal? & ,human ,s]vices    
%all issue f9al regulations implem5t+ ! 
am5dm5ts made by p>agraph 7#a74