,i  #aag? ,,congress  #b;d ,session  ,h4
 ,r4 #gbec  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,m>* #bh1 #bjbb,mr4   
,pet]s 7= himself1 ,mr4 ,joyce (        
,p5nsylvania1 & ,ms4 ,s*ri]7 introduc$ !
 foll[+ bill2 :i* 0 ref]r$ to !         
,committee on ,en]gy & ,comm]ce  ,a     
,,bill  ,to am5d ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act to provide =           
cl>ification ( requirem5ts = !          
remanufactur+ ( m$ical devices1 & = o!r 
purposes4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,cl>ify+ ,remanufactur+ to 
,protect ,pati5t ,safety ,act ( #bjbb4  
#b4 ,cl>ification ( remanufactur+ 9     
def9ition ,section #eaj ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfj7 is am5d$-- 7#a7 by      
subsection 7a71 by am5d+ p>agraph 7#a7  
to read z foll[s3  7#a7 ,! t]m          
manufacture1 prep>ation1 propagation1   
comp\nd+1 or process+ %all include !    
foll[+3 7,a7 ,repackag+ or o!rwise *ang+
 ! conta9]1 wrapp]1 or label+ ( any drug
 package or device package 9 fur!rance (

 ! di/ribution ( ! drug or device f !   
orig9al place ( manufacture to ! p]son  
:o makes f9al deliv]y or sale to !      
ultimate consum] or us]4  7,b7          
,remanufactur+ ( any f9i%$ device by    
engag+ 9 any act t c\ld significantly   
*ange ! p]=mance or safety              
specifications1 or int5d$ use1 ( ! f9i%$
 device1 includ+ by significantly       
*ang+-- 7i7 a /]ilization me?od2  7ii7 a
 reprocess+ in/ruction2  7iii7 a control
 me*anism1 op]at+ pr9ciple1 or en]gy    
input or output2  7iv7 ! anatomical     
location ( use2 or  7v7 ! design4  2 &  
7#b7 9 subsection 7j71 by add+ at ! end 
! foll[+3  7#f7 ,! ,secret>y %all       
require t li/s ( devices report$        
pursuant to p>agraph 7#b7 specifically  
id5tify 9 any su* li/ ^? devices t h be5
 or are be+ remanufactur$ z describ$ 9  
subsection 7a77#a77;,b74  4  #c4        
,inspection ( device remanufactur+      
e/abli%m5ts ,section #eaj7;h7 ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #cfj7;h77 is am5d$-- 7#a7 9   

p>agraph 7#d7-- 7,a7 by r$esignat+      
subp>agraph 7,h7 z subp>agraph 7,g72 &  
7,b7 by ins]t+ aft] subp>agraph 7,f7 !  
foll[+3  7,g7 ,:e!r ! e/abli%m5t is     
regi/]$ z a remanufactur] or o!rwise    
believ$ to be engag$ 9 remanufactur+4  2
 &  7#b7 9 p>agraph 7#f77;,a7-- 7,a7 9  
clause 7i71 by /rik+ & at ! end2  7,b7 9
 clause 7ii71 by ins]t+ & aft] !        
semicolon2 &  7,c7 by add+ at ! end !   
foll[+3  7iii7 ! numb] ( e/abli%m5ts    
regi/]$ z remanufactur]s t ! ,secret>y  
inspect$ 9 ! previ\s cal5d> ye>2  4  #d4
 ,device remanufactur+ public education 
7a7 ,9 g5]al ,! ,secret>y ( ,heal? &    
,human ,s]vices %all hold at lea/ "o    
public =um )9 #ab mon?s aft] ! date (   
enactm5t ( ?is ,act1 & %all take o!r    
ongo+ /eps z necess>y1 to increase      
public aw>5ess ( ! requirem5ts          
applicable to device remanufactur+1     
includ+-- 7#a7 hold+ web9>s2 &  7#b7    
engag+ 9 o!r outrea* to regulat$        
indu/ry1 pr(essional societies1 advocacy
 gr\ps1 ,/ate & local gov]nm5tal        

entities1 & o!r /akehold]s4  7b7 ,report
  7#a7 ,9 g5]al ,n lat] ?an #b ye>s aft]
 ! date ( enactm5t ( ?is ,act1 !        
,secret>y ( ,heal? & ,human ,s]vices    
%all-- 7,a7 prep>e & po/ on ! website ( 
! ,food & ,drug ,adm9i/ration a report )
 reg>d to ! remanufactur+ ( devices2 &  
7,b7 brief ! ,committee on ,en]gy &     
,comm]ce ( ! ,h\se ( ,repres5tatives & !
 ,committee on ,heal?1 ,education1      
,labor1 & ,p5sions ( ! ,s5ate reg>d+ !  
f9d+s ( su* report4  7#b7 ,cont5ts ,!   
report "u p>agraph 7#a7 %all include !  
foll[+3 7,a7 ,a description ( !         
activities c>ri$ out1 & additional      
activities int5d$ to be c>ri$ out1 "u   
subsection 7a74  7,b7 ,! numb] (        
remanufactur+ e/abli%m5t regi/rations & 
remanufactur$ device li/+s "u section   
#eaj ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj71 &  
any tr5ds 9 su* regi/rations & li/+s4   
7,c7 ,an assessm5t ( :e!r ! ,food &     
,drug ,adm9i/ration %\ld issue guidance 
= remanufactur]s on compliance ) !      

e/abli%m5t regi/ration & device li/+    
requirem5ts ( su* section #eaj4  7,d7 ,a
 summ>y ( inspections c>ri$ out1 w>n+   
lett]s & o!r advisory actions1 &        
en=cem5t actions relat+ to remanufactur+
 e/abli%m5ts s9ce ! date ( enactm5t (   
?is ,act4  7,e7 ,! /atus ( actions      
und]tak5 pursuant to ! report issu$ by !
 ,secret>y pursuant to section #gaj ( ! 
,,fda ,reau?orization ,act ( #bjag      
7,public ,law #aae-eb74  7#c7 ,annual   
updates ,on an annual basis1 ! ,secret>y
 ( ,heal? & ,human ,s]vices %all-- 7,a7 
update ! report requir$ by ?is          
subsection ) reg>d to ! in=mation       
describ$ 9 subp>agraphs 7,b7 & 7,d7 (   
p>agraph 7#b72 &  7,b7 po/ ea* su*      
update on ! website ( ! ,food & ,drug   
,adm9i/ration4  7c7 ,def9ition ,9 ?is   
section & section #e1 ! t]m device has !
 mean+ giv5 to su* t]m 9 section #bja ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
7#ba ,u4,s4,c4 #cba74  #e4 ,enhanc$     
communications reg>d+ remanufactur+ ,!  
,secret>y %all implem5t a process1 to be

 po/$ on ! website ( ! ,food & ,drug    
,adm9i/ration1 to receive ?r\gh ! ,food 
& ,drug ,adm9i/ration submissions f     
,/ate regulatory bodies & o!r ,/ate     
au?orities-- 7#a7 express+ conc]ns t an 
entity t is remanufactur+ devices-- 7,a7
 is n regi/]$ "u section #eaj ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #cfj72 or  7,b7 may o!rwise be
 act+ contr>y to ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et 
seq472 &  7#b7 describ+ any actions tak5
 by ,/ate au?orities aga9/ su* entity4