,,ii  #aag? ,,congress  #b;d ,session   
,s4 #dccc  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,may #bf1 #bjbb,ms4    
,smi? 7= h]self & ,mr4 ,m>%all7         
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to deem c]ta9 products      
regulat$ by ! ,food & ,drug             
,adm9i/ration z drugs4  #a4 ,%ort title 
,?is ,act may be cit$ z ! ,consi/5t     
,legal ,evaluation ,& ,regulation (     
,m$ical ,products ,act or ! ,,cle> ,act4
  #b4 ,regulation ( c]ta9 products z    
drugs  7a7 ,9 g5]al ,section #ejc ( !   
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cec7 is am5d$ by add+ at
 ! end ! foll[+3  7h7 ,deem+ c]ta9      
products z drugs  7#a7 ,9 g5]al ,any    
contra/ ag5t1 radioactive drug1 ,,otc   
monograph drug1 or oph?almic drug       
article %all be deem$ to be a drug "u   
section #bja7;g7 & n a device "u section
 #bja7;h74  7#b7 ,def9itions ,= purposes
 ( ?is subsection-- 7,a7 ! t]m contra/  

ag5t means an article t is int5d$ = use 
9 conjunction ) an applicable m$ical    
imag+ device1 &-- 7i7 is a diagno/ic    
radioph>maceutical1 z def9$ 9 section   
#cae4b & #fja4ca ( title #ba1 ,code (   
,f$]al ,regulations 7or any successor   
regulations72 or  7ii7 is a diagno/ic   
ag5t t improves ! visualization (       
/ructure or function )9 ! body by       
increas+ ! relative diff]5ce 9 signal   
int5sity )9 ! t>get tissue1 /ructure1 or
 fluid2  7,b7 ! t]m oph?almic drug      
article means any eye cup1 eye dropp]1  
or o!r non-invasive & non-implant$      
disp5s] int5d$ = oph?almic use if       
packag$ ) ! drug ) :i* su* article is   
int5d$ to be us$2  7,c7 ! t]m ,,otc     
monograph drug has ! mean+ giv5 su* t]m 
9 section #gdd,l2 &  7,d7 ! t]m         
radioactive drug has ! mean+ giv5 su*   
t]m 9 section #caj4c7n7 ( title #ba1    
,code ( ,f$]al ,regulations 7or any     
successor regulations71 except t su* t]m
 does n include-- 7i7 implants or       
articles simil> to an implant2  7ii7    

articles t apply radiation f outside ( !
 body2 or  7iii7 ! radiation s\rce ( an 
article describ$ 9 clause 7i7 or 7ii74  
7#c7 ,no effect on det]m9ations reg>d+  
o!r drugs or devices ,p>agraph 7#a7 %all
 n be con/ru$ z be>+ on1 or be+ relevant
 to1 ! "q ( :e!r any product o!r ?an a  
drug describ$ 9 su* p>agraph is a device
 z def9$ by section #bja7;h7 or a drug z
 def9$ by section #bja7;g74  4  7b7     
,application ,! am5dm5t made by         
subsection 7a7 %all apply to any        
application submitt$ "u subsection 7b7  
or 7j7 ( section #eje ( ! ,f$]al ,food1 
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7 & to any application submitt$ "u  
subsection 7a7 or 7k7 ( section #cea ( !
 ,public ,heal? ,s]vice ,act 7#db       
,u4,s4,c4 #bfb71 :e!r su* submission 0  
prior to1 on1 or aft] ! date ( enactm5t 
( ?is ,act1 & %all apply to all actions 
p5d+ on ! day ( enactm5t ( ?is ,act4