,i  #aagth ,,congress  #b;d ,session    
,h4 ,r4 #gaib  ,,in ,,the ,,house ,,of  
,,representatives  ,march #ba1 #bjbb,ms4
 ,schrier introduced the following bill2
 which was referred to the ,committee on
 ,energy and ,commerce  ,a ,,bill  ,to  
provide for the establishment of a panel
 on the real world impact of diagnostic 
medical devices1 and for other purposes4
  #a4 ,short title ,this ,act may be    
cited as the ,diagnostic ,device        
,advisory ,committee ,act4  #b4 ,real   
,world ,impact of ,medical ,devices     
,panel  7a7 ,in general ,the ,secretary 
of ,health and ,human ,services 7in this
 section referred to as the ,secretary7 
shall1 without regard to the provisions 
of title #e1 ,united ,states ,code1     
governing appointments in the           
competitive service1 and without regard 
to the provisions of chapter #ea and    
subchapter ,,iii of chapter #ec of such 
title relating to classification and    
,general ,schedule pay rates1 amend the 
charter of the ,medical ,devices        

,advisory ,committee 7or successor      
advisory committee7 to establish a panel
 of experts on diagnostic medical device
 products for the purpose of providing  
advice to the ,secretary in connection  
with the real world impact of the       
clearance1 classification1 approval1 and
 authorization of devices1 including    
diagnostic devices1 under sections      
#eaj7k71 #eac7;f71 #eae1 and #efd of the
 ,federal ,food1 ,drug1 and ,cosmetic   
,act 7#ba ,u4,s4,c4 #cfj7k71 #cfj;c7f71 
#cfj;e1 and #cfj;bbb-#c7 to be known as 
the ,real ,world ,impact of ,medical    
,devices ,panel 7referred to in this    
section as the ,panel74  7b7            
,application of ,,faca ,the ,federal    
,advisory ,committee ,act shall apply to
 the ,panel4  7c7 ,membership  7#a7 ,in 
general ,the ,panel shall consist of #ae
 members1 including the ,chair4  7#b7   
,representation #aa members of the      
,panel shall be voting members4 ,of the 
remaining #d members of the ,panel--    
7,a7 #a shall be a representative of    

consumer interests2  7,b7 #a shall be a 
representative of the interests of the  
device manufacturing industry2 and  7,c7
 #b shall be public health or population
 health-specific representatives4  7#c7 
,term ,the members of the ,panel        
specified in subparagraphs 7,a7 through 
7,c7 of paragraph 7#b7 shall be selected
 by the ,secretary and shall be invited 
to serve for rotating terms of such     
duration as specified by the ,secretary1
 except that any member appointed to    
fill a vacancy for an unexpired term    
shall be appointed for the remainder of 
that term4  7d7 ,duties ,the ,panel     
shall provide to the ,secretary-- 7#a7  
advice and recommendations on the real  
world impact of the clearance1          
classification1 approval1 and           
authorization of devices1 including     
diagnostic devices1 under sections      
#eaj7k71 #eac7;f71 #eae1 and #efd of the
 ,federal ,food1 ,drug1 and ,cosmetic   
,act 7#ba ,u4,s4,c4 #cfj7k71 #cfj;c7f71 
#cfj;e1 and #cfj;bbb-#c71 including the 

impact of such devices on rural1        
underserved1 or minority populations2   
and  7#b7 register comments about the   
negative and positive impacts of such   
devices on the ,united ,states          
population1 the risk assessment posed by
 the use of such devices1 and the need  
such devices would fill4  7e7           
,consideration of recommendations ,the  
,secretary1 acting through the          
,commissioner of ,food and ,drugs1 and  
any other applicable official shall1 in 
making any final decisions1 or amending 
existing decisions with respect to the  
clearance1 classification1 approval1 and
 authorization of devices1 including    
diagnostic devices1 under sections      
#eaj7k71 #eac7;f71 #eae1 and #efd of the
 ,federal ,food1 ,drug1 and ,cosmetic   
,act 7#ba ,u4,s4,c4 #cfj7k71 #cfj;c7f71 
#cfj;e1 and #cfj;bbb-#c71 take comments 
received from the ,panel under          
advisement4  7f7 ,meetings  7#a7        
,frequency ,the ,panel shall hold at    
least #a meeting each year1 at the call 

of the ,chair4  7#b7 ,recordings        
available ,recordings of the meetings of
 the ,panel shall be available on the   
public website of the ,food and ,drug   
,administration4