,,ii  #aagth ,,congress  #ast ,session  
,s4 #aejh  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,april #bi1    
#bjba,mr4 ,marshall 7for himself1 ,ms4  
,smith1 and ,mr4 ,cassidy7 introduced   
the following bill2 which was read twice
 and referred to the ,committee on      
,health1 ,education1 ,labor1 and        
,pensions  ,a ,,bill  ,to provide for   
the use of emergency use authorization  
data and real world evidence gathered   
during an emergency to support premarket
 applications for drugs1 biological     
products1 and devices1 and for other    
purposes4  #a4 ,using emergency use     
authorization data and real world       
evidence gathered during an emergency to
 support premarket applications for     
drugs1 biological products1 and devices 
7a7 ,in general ,data generated to      
support an authorization under section  
#efd of the ,federal ,food1 ,drug1 and  
,cosmetic ,act 7#ba ,u4,s4,c4           
#cfj;bbb-#c7 with respect to a drug1    
biological product1 or device1 and real 

world evidence relating to such drug1   
biological product1 or device used      
pursuant to such authorization1 may     
constitute valid scientific evidence1   
and shall be considered for purposes    
of-- 7#a7 reviewing submissions pursuant
 to section #eje of the ,federal ,food1 
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cee7 and section #cea of the ,public  
,health ,service ,act 7#db ,u4,s4,c4    
#bfb72  7#b7 reviewing submissions      
pursuant to sections #eaj7k71 #eac7;f71 
and #eae of the ,federal ,food1 ,drug1  
and ,cosmetic ,act 7#ba ,u4,s4,c4 #ba   
,u4,s4,c4 #cfj7k71 #cfj;c7f71 or        
#cfj;e72 and  7#c7 otherwise meeting the
 requirements of such ,act and such     
section #cea of the ,public ,health     
,service ,act4  7b7 ,applicability of   
certain categorizations for premarket   
device review ,in the case of a device  
receiving an authorization under section
 #efd of the ,federal ,food1 ,drug1 and 
,cosmetic ,act 7#ba ,u4,s4,c4           
#cfj;bbb-#c7 for which the ,secretary   

has determined1 in accordance with      
subsection 7m7 of such section1 that a  
laboratory examination or procedure     
associated with such device is deemed to
 be in the category of examinations and 
procedures described in section         
#cec7;d77#c7 of the ,public ,health     
,service ,act 7#db ,u4,s4,c4 #bfb71 such
 determination shall apply with regard  
to a submission pursuant to section     
#eaj7k71 #eac7;f71 or #eae of the       
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #ba ,u4,s4,c4       
#cfj7k71 #cfj;c7f71 or #cfj;e7 for such 
device1 unless the ,secretary 7taking   
into account any applicable conditions  
specified pursuant to subsection 7m77#b7
 of section #efd of the ,federal ,food1 
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cfj;bbb-#c77 identifies new           
information not included in the request 
for authorization that indicates that   
the criteria under section #cec7;d77#c7 
of the ,public ,health ,service ,act    
7#db ,u4,s4,c4 #bfb7 are not met4  7c7  

,rule of construction ,nothing in this  
section shall be construed as altering  
the review standards or otherwise       
affecting the requirements under section
 #eje1 #eaj7k71 #eac7;f71 or #eae of the
 ,federal ,food1 ,drug1 and ,cosmetic   
,act 7#ba ,u4,s4,c4 #ba ,u4,s4,c4 #cee1 
#cfj7k71 #cfj;c7f71 or #cfj;e7 or under 
section #cea of the ,public ,health     
,service ,act 7#db ,u4,s4,c4 #bfb7 for  
the clearance or approval of a device1  
approval of a drug1 or licensure of a   
biological product4