,i  #aad? ,,congress  #a/ ,session  ,h4 
,r4 #bdbf  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,may #ai1 #bjae ,mr4  
,%imkus introduc$ ! foll[+ bill2 :i* 0  
ref]r$ to ! ,committee on ,en]gy &      
,comm]ce  ,a ,,bill  ,to am5d ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act ) respect
 to eas+ regulatory burd5 ) respect to  
c]ta9 class ,i & class ,,ii devices4    
#a4 ,eas+ regulatory burd5 ) respect to 
c]ta9 class ,i & class ,,ii devices  7a7
 ,class ,i devices ,section #eaj7l7 ( ! 
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cfj7l77 is am5d$-- 7#a7 
by /rik+ ,a report "u subsection 7k7 &  
ins]t+ 7#a7 ,a report "u subsection 7k72
 &  7#b7 by add+ at ! end ! foll[+ new  
p>agraph3  7#b7 ,n lat] ?an #abj days   
aft] ! date ( ! enactm5t ( ! #ba/       
,c5tury ,cures ,act1 ! ,secret>y %all   
id5tify1 ?r\gh publication 9 ! ,f$]al   
,regi/]1 any type ( class ,i device t ! 
,secret>y det]m9es no long] requires a  
report "u subsection 7k7 to provide     
reasonable assurance ( safety &         

effectiv5ess4 ,^u su* publication--     
7,a7 ea* type ( class ,i device s       
id5tifi$ %all be exempt f ! requirem5t =
 a report "u subsection 7k72 &  7,b7 !  
classification regulation applicable to 
ea* su* type ( device %all be deem$     
am5d$ to incorporate su* exemption4  4  
7b7 ,class ,,ii devices ,section #eaj7m7
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4 #cfj7m77 is am5d$-- 
7#a7 by /rik+ p>agraph 7#a7 & ins]t+ !  
foll[+ new p>agraph3  7#a7 ,! ,secret>y 
%all-- 7,a7 n lat] ?an #fj days aft] !  
date ( ! enactm5t ( ! #ba/ ,c5tury      
,cures ,act--  7i7 publi% 9 ! ,f$]al    
,regi/] a notice t conta9s a li/ ( ea*  
type ( class ,,ii device t ! ,secret>y  
det]m9es no long] requires a report "u  
subsection 7k7 to provide reasonable    
assurance ( safety & effectiv5ess2 &    
7ii7 provide = a p]iod ( n less ?an #fj 
days = public comm5t beg9n+ on ! date ( 
! publication ( su* notice2 &  7,b7 n   
lat] ?an #ahj days aft] ! date ( !      
enactm5t ( #ba/ ,c5tury ,cures ,act1    

publi% 9 ! ,f$]al ,regi/] a li/         
repres5t+ ! ,secret>y's f9al det]m9ation
 ) respect to ! devices conta9$ 9 ! li/ 
publi%$ "u subp>agraph 7,a74  2  7#b7 9 
p>agraph 7#b7--  7,a7 by /rik+ #a day   
aft] ! date ( publication ( a li/ "u ?is
 subsection1 & ins]t+ #a day aft] ! date
 ( publication ( ! f9al li/ "u p>agraph 
7#a77;,b712 &  7,b7 by /rik+ #cj-;day   
p]iod & ins]t+ #fj-;day p]iod2 &  7#c7  
by add+ at ! end ! foll[+ new p>agraph3 
7#c7 ,^u ! publication ( ! f9al li/ "u  
p>agraph 7#a77;,b7--  7,a7 ea* type (   
class ,,ii device s li/$ %all be exempt 
f ! requirem5t = a report "u subsection 
7k72 &  7,b7 ! classification regulation
 applicable to ea* su* type ( device    
%all be deem$ am5d$ to incorporate su*  
exemption4  4