,,ii  #aag? ,,congress  #b;d ,session   
,s4 #dcia  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,june #ad1 #bjbb,mr4   
,cassidy introduc$ ! foll[+ bill2 :i* 0 
read twice & ref]r$ to ! ,committee on  
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to e/abli% rules = export   
c]tification ( devices manufactur$      
outside ( ! ,unit$ ,/ates4  #a4 ,%ort   
title ,?is ,act may be cit$ z !         
,correct+ a ,lack ( ,effici5t1          
,adequate1 & ,reasonable ,docum5tation  
,act or ! ,,cle> ,docum5tation ,act4    
#b4 ,c]tification ( import$ devices     
,section #hja7;e77#d77;,e7 ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #chd7;e77#d77 is am5d$ by     
/rik+ clause 7iii7 & ins]t+ ! foll[+3   
7,f7 7i7 ,! ,secret>y %all issue a      
c]tification "u subp>agraph 7,a7 = a    
device manufactur$ by an e/abli%m5t     
locat$ outside ( ! ,unit$ ,/ates t is   
regi/]$ "u section #eaj7;i71 if !       
device-- 7,i7 is li/$ pursuant to       
section #eaj7;j72  7,,ii7 has be5       

approv$ "u section #eae or cle>$ "u     
section #eaj7k71 or is n requir$ to     
submit a prem>ket report pursuant to    
subsection 7l7 or 7m7 ( section #eaj2   
7,,iii7 is import$ or (f]$ = import into
 ! ,unit$ ,/ates2 &  7,,iv7 o!rwise     
meets ! requirem5ts ( ?is ,act4  7ii7   
7,i7 ,a c]tification = a device describ$
 9 clause 7i7-- 7aa7 %all be subject to 
! fee describ$ 9 subp>agraph 7,b72 &    
7bb7 not)/&+ subp>agraph 7,c71 %all     
address & include ! same mat]ial        
in=mation z a ,c]tificate to ,=eign     
,gov]nm5t1 & %all h a docum5t title t   
includes ! words ,c]tificate to ,=eign  
,gov]nm5t4  7iii7 ,! requirem5ts &      
proc$ures ( subp>agraph 7,e7 %all apply 
to a d5ial ( a c]tification "u ?is      
subp>agraph4  4