,i  #aae? ,,congress  #a/ ,session  ,h4 
,r4 #bdgd  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,may #af1 #bjag,mrs4  
,mimi ,walt]s ( ,cali=nia 7= h]self &   
,mr4 ,b]a7 introduc$ ! foll[+ bill2 :i* 
0 ref]r$ to ! ,committee on ,en]gy &    
,comm]ce  ,a ,,bill  ,to am5d ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act to       
provide an alt]native /&>d = sub/antial 
equival5ce det]m9ations = devices1 & =  
o!r purposes4  #a4 ,%ort title ,?is ,act
 may be cit$ z ! ,m$ical ,product       
,review ,h>monization ,act ( #bjag4  #b4
 ,alt]native sub/antial equival5ce %[+  
,subsection #eac7;i77#a7 ( ! ,f$]al     
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfj;c7i77#a77 is am5d$--     
7#a7 by r$esignat+ subp>agraphs 7,b7    
?r\gh 7,f7 z subp>agraphs 7,c7 ?r\gh    
7,g71 respectively2  7#b7 by ins]t+ aft]
 subp>agraph 7,a7 ! foll[+3  7,b7  7i7  
,z an alt]native to clause 7ii7 (       
subp>agraph 7,a71 & = ! purpose (       
det]m9+ sub/antial equival5ce "u        
subsection 7f7 & section #ebj7l71 a     

p]son may submit in=mation to !         
,secret>y t demon/rates t a device      
con=ms ) national or int]national /&>ds1
 /&>ds e/abli%$ or recogniz$ "u section 
#ead1 or guidance docum5ts develop$ by !
 ,secret>y to demon/rate t a device is z
 safe & effective z a legally m>ket$    
device1 not)/&+ te*nological diff]5ces4 
7ii7 ,any p]son may propose to !        
,secret>y1 = purposes ( clause 7i71 a   
national or int]national /&>d1 a /&>d   
e/abli%$ or recogniz$ "u section #ead1  
or a guidance docum5t develop$ by !     
,secret>y4 ,n lat] ?an #fj days aft]    
receipt ( any su* proposal1 ! ,secret>y 
%all provide to ! p]son submitt+ !      
proposal a writt5 det]m9ation--  7,i7   
accept+ all1 "p1 or none ( ! proposal = 
purposes ( demon/rat+ sub/antial        
equival5ce "u ?is p>agraph2 &  7,,ii7   
/at+ ! full rationale 7includ+ !        
sci5tific1 te*nical1 & regulatory basis7
 = ! ,secret>y's det]m9ation4  7iii7 ,! 
,secret>y %all-- 7,i7 except z provid$ 9
 subclause 7,,ii71 comply ) !           

requirem5ts = public p>ticipation       
describ$ 9 section #gja7;h77#a77;,c7    
be=e fir/ us+ a /&>d or guidance docum5t
 = purposes ( ?is subp>agraph2 &  7,,ii7
 9 ! case ( e/abli%+ or recogniz+ a     
/&>d1 comply ) ! requirem5ts describ$ 9 
section #ead = e/abli%+ or recogniz+1 z 
applicable1 a p]=mance /&>d4  7iv7 ,a   
p]son submitt+ a notification "u section
 #eaj7k7 may rely on a /&>d or guidance 
docum5t id5tifi$1 e/abli%$1 or recogniz$
 by ! ,secret>y 9 accordance ) clause   
7iii7 to resolve "s or all ( ! diff]5ces
 t exi/ betwe5 a new device & its       
legally m>ket$ pr$icate device to       
demon/rate sub/antial equival5ce4  2 &  
7#c7 9 subp>agraph 7,f7 7z r$esignat$ by
 p>agraph 7#a771 by add+ at ! end !     
foll[+3  7iv7 ,! reliance on /&>ds or   
guidance docum5ts to demon/rate         
sub/antial equival5ce z describ$ 9      
subp>agraph 7,b7 %all be optional & h no
 effect on ! e/abli%m5t ( sub/antial    
equival5ce pursuant to subp>agraph 7,a7 
:]e su* option is n ex]cis$4  4