,i  #aad? ,,congress  #a/ ,session  ,h4 
,r4 #bdbe  ,,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$]al  
,food1 ,drug1 & ,cosmetic ,act ) respect
 to ! recognition ( /&>ds4  #a4         
,recognition ( /&>ds ,section #ead7;c7 (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 7#ba ,u4,s4,c4 #cfj;d7c77 is am5d$--   
7#a7 9 p>agraph 7#a71 by ins]t+ aft]    
subp>agraph 7,b7 ! foll[+ new           
subp>agraphs3  7,c7  7i7 ,any p]son may 
submit a reque/ = recognition "u        
subp>agraph 7,a7 ( all or "p ( an       
appropriate /&>d e/abli%$ by a          
nationally or int]nationally recogniz$  
/&>d organization4  7ii7 ,n lat] ?an #fj
 days aft] ! ,secret>y receives su* a   
reque/1 ! ,secret>y %all--  7,i7 make a 
det]m9ation to recognize all1 "p1 or    
none ( ! /&>d t is ! subject ( ! reque/2
 &  7,,ii7 issue to ! p]son :o submitt$ 
su* reque/ a response 9 writ+ t /ates ! 

,secret>y's rationale = t det]m9ation1  
includ+ ! sci5tific1 te*nical1          
regulatory1 or o!r basis = su*          
det]m9ation2  7iii7 ,! ,secret>y make a 
response issu$ "u clause 7ii77,,ii7     
publicly available1 9 su* mann] z !     
,secret>y det]m9es appropriate4  7iv7 ,!
 ,secret>y %all take su* actions z may  
be necess>y to implem5t all or "p ( a   
/&>d recogniz$ "u subclause 7,i71 9     
accordance ) subp>agraph 7,a74  7,d7 ,! 
,secret>y %all make publicly available1 
9 su* mann] z ! ,secret>y det]m9es      
appropriate1 ! rationale = recognition  
"u subp>agraph 7,a7 ( "p ( a /&>d1      
includ+ ! sci5tific1 te*nical1          
regulatory1 or o!r basis = su*          
recognition4  2 &  7#b7 by add+ at ! end
 ! foll[+ new p>agraphs3  7#d7 ,tra9+ on
 use ( /&>ds ,! ,secret>y %all provide  
to all employees ( ! ,food & ,drug      
,adm9i/ration :o review prem>ket        
submissions = devices p]iodic tra9+ on !
 concept & use ( recogniz$ /&>ds =      
purposes ( meet+ a prem>ket submission  

requirem5t or o!r applicable requirem5t 
"u ?is ,act1 includ+ /&>ds relevant to  
an employee's area ( device review4     
7#e7 ,guidance  7,a7 ,draft guidance ,! 
,secret>y %all publi% guidance id5tify+ 
! pr9ciples = recogniz+ /&>ds "u ?is    
section4 ,9 publi%+ su* guidance1 !     
,secret>y %all consid] ! exp]i5ce )1 &  
reliance on1 a /&>d by o!r ,f$]al       
regulatory au?orities & ! device        
indu/ry1 & :e!r recognition ( a /&>d w  
promote h>monization among regulatory   
au?orities 9 ! regulation ( devices4    
7,b7 ,tim+ ,! ,secret>y %all publi%--   
7i7 draft guidance "u subp>agraph 7,a7 n
 lat] ?an #ab mon?s aft] ! date ( !     
enactm5t ( ! #ba/ ,c5tury ,cures ,act2 &
  7ii7 f9al guidance n lat] ?an #ab     
mon?s ( ! close ( ! public comm5t p]iod 
= ! draft guidance "u clause 7i74  4