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,,unit$ ,,/ates  ,octob] #ba1 #bjae ,mr4
 ,g>dn] 7= himself & ,mr4 ,donnelly7    
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to am5d ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act ) respect to !  
humanit>ian device exemption4  #a4 ,%ort
 title  ,?is ,act may be cit$ z ! ,r>e  
,disease ,innovation ,act4  #b4         
,humanit>ian device exemption           
application  7a7 ,9 g5]al ,section      
#ebj7m7 ( ! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7 is
 am5d$-- 7#a7 9 p>agraph 7#a7 by /rik+  
few] ?an #d1jjj & ins]t+ n m ?an #h1jjj2
  7#b7 9 p>agraph 7#b77;,a7 by /rik+    
few] ?an #d1jjj & ins]t+ n m ?an #h1jjj2
 &  7#c7 9 p>agraph 7#f77;,a77ii71 by   
/rik+ #d1jjj & ins]t+ #h1jjj4  7b7      
,guidance docum5t on probable b5efit ,n 
lat] ?an #ah mon?s aft] ! date (        
enactm5t ( ?is ,act1 ! ,secret>y (      

,heal? & ,human ,s]vices1 act+ ?r\gh !  
,commission] ( ,food & ,drugs1 %all     
publi% a draft guidance docum5t t def9es
 ! crit]ia = e/abli%+ probable b5efit z 
t t]m is us$ 9 section #ebj7m77#b77;,c7 
( ! ,f$]al ,food1 ,drug1 & ,cosmetic    
,act 7#ba ,u4,s4,c4 #cfj;j7m77#b77;,c774
  7c7 ,reports to ,congress ,five ye>s  
aft] ! date ( enactm5t ( ?is ,act & e #e
 ye>s !reaft]1 ! ,secret>y ( ,heal? &   
,human ,s]vices %all submit to ,congress
 a report on ! effect ( ! am5dm5ts made 
by subsection 7a74