,i  #aaeth ,,congress  #ast ,session    
,h4 ,r4 #bdgd  ,,in ,,the ,,house ,,of  
,,representatives  ,may #af1 #bjag,mrs4 
,mimi ,walters of ,california 7for      
herself and ,mr4 ,bera7 introduced the  
following bill2 which was referred to   
the ,committee on ,energy and ,commerce 
,a ,,bill  ,to amend the ,federal ,food1
 ,drug1 and ,cosmetic ,act to provide an
 alternative standard for substantial   
equivalence determinations for devices1 
and for other purposes4  #a4 ,short     
title ,this ,act may be cited as the    
,medical ,product ,review ,harmonization
 ,act of #bjag4  #b4 ,alternative       
substantial equivalence showing         
,subsection #eac7;i77#a7 of the ,federal
 ,food1 ,drug1 and ,cosmetic ,act 7#ba  
,u4,s4,c4 #cfj;c7i77#a77 is amended--   
7#a7 by redesignating subparagraphs 7,b7
 through 7,f7 as subparagraphs 7,c7     
through 7,g71 respectively2  7#b7 by    
inserting after subparagraph 7,a7 the   
following3  7,b7  7i7 ,as an alternative
 to clause 7ii7 of subparagraph 7,a71   

and for the purpose of determining      
substantial equivalence under subsection
 7f7 and section #ebj7l71 a person may  
submit information to the ,secretary    
that demonstrates that a device conforms
 with national or international         
standards1 standards established or     
recognized under section #ead1 or       
guidance documents developed by the     
,secretary to demonstrate that a device 
is as safe and effective as a legally   
marketed device1 notwithstanding        
technological differences4  7ii7 ,any   
person may propose to the ,secretary1   
for purposes of clause 7i71 a national  
or international standard1 a standard   
established or recognized under section 
#ead1 or a guidance document developed  
by the ,secretary4 ,not later than #fj  
days after receipt of any such proposal1
 the ,secretary shall provide to the    
person submitting the proposal a written
 determination--  7,i7 accepting all1   
part1 or none of the proposal for       
purposes of demonstrating substantial   

equivalence under this paragraph2 and   
7,,ii7 stating the full rationale       
7including the scientific1 technical1   
and regulatory basis7 for the           
,secretary's determination4  7iii7 ,the 
,secretary shall-- 7,i7 except as       
provided in subclause 7,,ii71 comply    
with the requirements for public        
participation described in section      
#gja7;h77#a77;,c7 before first using a  
standard or guidance document for       
purposes of this subparagraph2 and      
7,,ii7 in the case of establishing or   
recognizing a standard1 comply with the 
requirements described in section #ead  
for establishing or recognizing1 as     
applicable1 a performance standard4     
7iv7 ,a person submitting a notification
 under section #eaj7k7 may rely on a    
standard or guidance document           
identified1 established1 or recognized  
by the ,secretary in accordance with    
clause 7iii7 to resolve some or all of  
the differences that exist between a new
 device and its legally marketed        

predicate device to demonstrate         
substantial equivalence4  2 and  7#c7 in
 subparagraph 7,f7 7as redesignated by  
paragraph 7#a771 by adding at the end   
the following3  7iv7 ,the reliance on   
standards or guidance documents to      
demonstrate substantial equivalence as  
described in subparagraph 7,b7 shall be 
optional and have no effect on the      
establishment of substantial equivalence
 pursuant to subparagraph 7,a7 where    
such option is not exercised4  4