,,ii  #aagth ,,congress  #b;d ,session  
,s4 #dcia  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,june #ad1     
#bjbb,mr4 ,cassidy introduced the       
following bill2 which was read twice and
 referred to the ,committee on ,health1 
,education1 ,labor1 and ,pensions  ,a   
,,bill  ,to establish rules for export  
certification of devices manufactured   
outside of the ,united ,states4  #a4    
,short title ,this ,act may be cited as 
the ,correcting a ,lack of ,efficient1  
,adequate1 and ,reasonable              
,documentation ,act or the ,,clear      
,documentation ,act4  #b4 ,certification
 of imported devices ,section           
#hja7;e77#d77;,e7 of the ,federal ,food1
 ,drug1 and ,cosmetic ,act 7#ba         
,u4,s4,c4 #chd7;e77#d77 is amended by   
striking clause 7iii7 and inserting the 
following3  7,f7 7i7 ,the ,secretary    
shall issue a certification under       
subparagraph 7,a7 for a device          
manufactured by an establishment located
 outside of the ,united ,states that is 

registered under section #eaj7;i71 if   
the device-- 7,i7 is listed pursuant to 
section #eaj7;j72  7,,ii7 has been      
approved under section #eae or cleared  
under section #eaj7k71 or is not        
required to submit a premarket report   
pursuant to subsection 7l7 or 7m7 of    
section #eaj2  7,,iii7 is imported or   
offered for import into the ,united     
,states2 and  7,,iv7 otherwise meets the
 requirements of this ,act4  7ii7 7,i7  
,a certification for a device described 
in clause 7i7-- 7aa7 shall be subject to
 the fee described in subparagraph 7,b72
 and  7bb7 notwithstanding subparagraph 
7,c71 shall address and include the same
 material information as a ,certificate 
to ,foreign ,government1 and shall have 
a document title that includes the words
 ,certificate to ,foreign ,government4  
7iii7 ,the requirements and procedures  
of subparagraph 7,e7 shall apply to a   
denial of a certification under this    
subparagraph4  4