,,ii  #aagth ,,congress  #b;d ,session  
,s4 #dccc  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,may #bf1      
#bjbb,ms4 ,smith 7for herself and ,mr4  
,marshall7 introduced the following     
bill2 which was read twice and referred 
to the ,committee on ,health1           
,education1 ,labor1 and ,pensions  ,a   
,,bill  ,to deem certain products       
regulated by the ,food and ,drug        
,administration as drugs4  #a4 ,short   
title ,this ,act may be cited as the    
,consistent ,legal ,evaluation ,and     
,regulation of ,medical ,products ,act  
or the ,,clear ,act4  #b4 ,regulation of
 certain products as drugs  7a7 ,in     
general ,section #ejc of the ,federal   
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cec7 is amended by adding at 
the end the following3  7h7 ,deeming    
certain products as drugs  7#a7 ,in     
general ,any contrast agent1 radioactive
 drug1 ,,otc monograph drug1 or         
ophthalmic drug article shall be deemed 
to be a drug under section #bja7;g7 and 

not a device under section #bja7;h74    
7#b7 ,definitions ,for purposes of this 
subsection-- 7,a7 the term contrast     
agent means an article that is intended 
for use in conjunction with an          
applicable medical imaging device1 and--
 7i7 is a diagnostic                    
radiopharmaceutical1 as defined in      
section #cae4b and #fja4ca of title #ba1
 ,code of ,federal ,regulations 7or any 
successor regulations72 or  7ii7 is a   
diagnostic agent that improves the      
visualization of structure or function  
within the body by increasing the       
relative difference in signal intensity 
within the target tissue1 structure1 or 
fluid2  7,b7 the term ophthalmic drug   
article means any eye cup1 eye dropper1 
or other non-invasive and non-implanted 
dispenser intended for ophthalmic use if
 packaged with the drug with which such 
article is intended to be used2  7,c7   
the term ,,otc monograph drug has the   
meaning given such term in section      
#gdd,l2 and  7,d7 the term radioactive  

drug has the meaning given such term in 
section #caj4c7n7 of title #ba1 ,code of
 ,federal ,regulations 7or any successor
 regulations71 except that such term    
does not include-- 7i7 implants or      
articles similar to an implant2  7ii7   
articles that apply radiation from      
outside of the body2 or  7iii7 the      
radiation source of an article described
 in clause 7i7 or 7ii74  7#c7 ,no effect
 on determinations regarding other drugs
 or devices ,paragraph 7#a7 shall not be
 construed as bearing on1 or being      
relevant to1 the question of whether any
 product other than a drug described in 
such paragraph is a device as defined by
 section #bja7;h7 or a drug as defined  
by section #bja7;g74  4  7b7            
,application ,the amendment made by     
subsection 7a7 shall apply to any       
application submitted under subsection  
7b7 or 7j7 of section #eje of the       
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cee7 and to any    
application submitted under subsection  

7a7 or 7k7 of section #cea of the       
,public ,health ,service ,act 7#db      
,u4,s4,c4 #bfb71 whether such submission
 was prior to1 on1 or after the date of 
enactment of this ,act1 and shall apply 
to all actions pending on the day of    
enactment of this ,act4