,i  #aad? ,,congress  #a/ ,session  ,h4 
,r4 #bdbg  ,,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$]al  
,food1 ,drug1 & ,cosmetic ,act ) respect
 to advisory committee process4  #a4    
,advisory committee process  7a7        
,classification panels ,p>agraph 7#e7 ( 
section #eac7;b7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cfj;c7b77 is am5d$-- 7#a7 by /rik+ 7#e7
 & ins]t+ 7#e77;,a72 &  7#b7 by add+ at 
! end ! foll[+3  7,b7 ,= review by a    
classification panel ( a prem>ket       
submission = a device1 ! ,secret>y      
%all--  7i7 provide an opportunity = !  
p]son ^: prem>ket submission is subject 
to panel review to provide              
recomm5dations on ! exp]tise ne$$ among 
! vot+ memb]s ( ! panel2 &  7ii7 give   
due consid]ation to su* recomm5dations &
 ensure t adequate exp]tise is repres5t$
 on advisory panels to assess--  7,i7 ! 

disease or condition = :i* ! device is  
int5d$ to cure1 treat1 mitigate1 prev5t1
 or diagnose2 &  7,,ii7 ! te*nology ( ! 
device4  7,c7 ,= purposes ( subp>agraph 
7,b77ii71 ! t]m adequate exp]tise means 
t ! memb]%ip ( ! classification panel   
review+ a prem>ket submission includes--
 7i7 two or m vot+ memb]s1 ) a specialty
 or o!r exp]tise cl9ically relevant to !
 device "u review2 &  7ii7 at lea/ "o   
vot+ memb] :o is kn[l$geable ab\t !     
te*nology ( ! device4  4  7b7 ,panel    
review process ,section #eac7;b77#f7 ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cfj;c7b77#f77 is am5d$--
  7#a7 9 subp>agraph 7,a77iii71 by      
ins]t+ be=e ! p]iod at ! end 1 includ+  
by designat+ a repres5tative :o w be    
provid$ a "t dur+ ! panel meet+ to      
address ! panel individually 7or        
accompani$ by exp]ts select$ by su*     
repres5tative7 = ! purpose ( correct+   
mis/atem5ts ( fact or provid+ cl>ify+   
in=mation1 subject to ! discretion (    
panel *airp]son44  7#b7 by /rik+        

subp>agraph 7,b7 & ins]t+ ! foll[+ new  
subp>agraph3  7,b7  7i7 ,any meet+ ( a  
classification panel ) respect to !     
review ( a prem>ket submission = a      
device %all-- 7,i7 provide adequate "t =
 initial pres5tations by ! p]son ^:     
prem>ket submission is specifically !   
subject ( su* review & by ! ,secret>y2 &
  7,,ii7 enc\rage free & op5            
p>ticipation by all int]e/$ p]sons4     
7ii7 ,foll[+ ! initial pres5tations     
describ$ 9 clause 7i71 ! panel may--    
7,i7 pose que/ions to a designat$       
repres5tative describ$ 9 subp>agraph    
7,a77iii72 &  7,,ii7 consid] ! responses
 to su* que/ions 9 ! panel's review ( ! 
prem>ket submission4  4