,i  #aai? ,,congress  #a/ ,session  ,h4 
,r4 #eaeh  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,septemb] #d1         
#bjbe,ms4 ,s*olt5 introduc$ ! foll[+    
bill2 :i* 0 ref]r$ to ! ,committee on   
,en]gy & ,comm]ce  ,a ,,bill  ,to am5d !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
reg>d+ ! approval ( comb9ation products 
consi/+ ( a g5]ic drug & a device1 & =  
o!r purposes4  #a4 ,%ort title ,?is ,act
 may be cit$ z ! ,fair ,price ,device   
,act4  #b4 ,g5]ic drugs = use ) devices 
,section #eje7;j7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;j77 is am5d$--  7#a7 9 p>agraph   
7#b77;,a7-- 7,a7 9 clause 7v7--  7i7 by 
/rik+ except = *anges requir$ because ( 
diff]5ces & ins]t+ except = *anges      
requir$ or appropriate1 z det]m9$ by !  
,secret>y1 because ( diff]5ces2 &  7ii7 
by ins]t+ 1 includ+ *anges z a result ( 
diff]5ces t are o!rwise p]mitt$ "u ?is  
subsection1 su* z *anges z a result (   
appropriate diff]5ces 9 ! device = use )
 ! new drug be=e ! semicolon2  7,b7 9   

clause 7vii71 by /rik+ ! & at ! end2    
7,c7 9 clause 7viii7 by /rik+ ! p]iod at
 ! end & ins]t+ 2 &2  7,d7 by ins]t+    
aft] clause 7viii7 ! foll[+ new clause3 
7ix7 if ! li/$ drug ref]r$ to 9 clause  
7i7 is int5d$ = use ) a device1 relevant
 in=mation z det]m9$ by ! ,secret>y to  
support t ! new drug = use ) ! device c 
be expect$ to h ! same cl9ical effect & 
safety pr(ile z ! li/$ drug = use ) !   
device :5 adm9i/]$ to pati5ts "u !      
conditions specifi$ 9 ! label+ ( ! drug1
 :i* in=mation--  7,i7 %all be 9        
addition to in=mation "u clauses 7i7    
?r\gh 7viii7 t is relevant1 z det]m9$ by
 ! ,secret>y1 to ! evaluation ( ! new   
drug = use ) ! device & ! device propos$
 = use ) ! new drug2 &  7,,ii7 may      
include--  7aa7 in=mation 7comp>ative & 
non-comp>ative7 reg>d+ ! device & its   
p]=mance1 includ+ in=mation ab\t !      
compatibility ( ! new drug ) ! device & 
in=mation reg>d+ ! deliv]y ( ! new drug 
:5 us$ ) ! device2  7bb7 comp>ative     
analyses ( ! new drug = use ) ! device &

 ! li/$ drug = use ) its device1 includ+
 in=mation id5tify+ any diff]5ces betwe5
 ! us] int]face ( ! new drug & li/$     
drug2 in=mation id5tify+ any diff]5ces  
betwe5 ! us] int]face ( ! device propos$
 = use ) ! new drug & ! device us$ ) !  
li/$ drug2 & in=mation to %[ t1 despite 
any su* diff]5ces1 ! new drug :5 us$ ) !
 device c be expect$ to h ! same cl9ical
 effect & safety pr(ile z ! li/$ drug :5
 us$ ) ! device :5 adm9i/]$ to pati5ts  
"u ! conditions specifi$ 9 ! label+ ( ! 
drug2 &  7cc7 comp>ative &              
non-comp>ative human factors /udies4  2 
&  7,e7 9 ! matt] foll[+ clause 7ix71 z 
ins]t$ by subp>agraph 7,d71 by /rik+    
?r\gh 7viii7 & ins]t+ ?r\gh 7ix72 &     
7#b7 9 p>agraph 7#d7-- 7,a7 9           
subp>agraph 7,g7--  7i7 by /rik+ except 
= *anges requir$ because ( diff]5ces &  
ins]t+ except = *anges requir$ or       
appropriate1 z det]m9$ by ! ,secret>y1  
because ( diff]5ces2 &  7ii7 by ins]t+ 1
 includ+ *anges z a result ( diff]5ces t
 are o!rwise p]mitt$ "u ?is subsection1 

su* z *anges z a result ( appropriate   
diff]5ces 9 ! device = use ) ! new drug 
be=e ! semicolon2  7,b7 by r$esignat+   
subp>agraphs 7,j7 ?r\gh 7,k7 z          
subp>agraphs 7,k7 ?r\gh 7,l72 &  7,c7 by
 ins]t+ aft] subp>agraph 7,i7 ! foll[+3 
7,j7 if ! li/$ drug is int5d$ = use ) a 
device1 in=mation submitt$ 9 !          
application is insuffici5t to %[ t ! new
 drug = use ) ! device c be expect$ to h
 ! same cl9ical effect & safety pr(ile z
 ! li/$ drug = use ) ! device :5        
adm9i/]$ to pati5ts "u ! conditions     
specifi$ 9 ! label+ ( ! drug2  4