,,ii  #aaeth ,,congress  #ast ,session  
,s4 #ajic  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,may #aj1 #bjag
 ,mr4 ,franken 7for himself and ,mr4    
,enzi7 introduced the following bill2   
which was read twice and referred to the
 ,committee on ,health1 ,education1     
,labor1 and ,pensions  ,a ,,bill  ,to   
amend the ,federal ,food1 ,drug1 and    
,cosmetic ,act to improve pediatric     
medical device application procedures4  
#a4 ,short title  ,this ,act may be     
cited as the ,pediatric ,device         
,development ,act4  #b4 ,pediatric uses 
of devices ,section #eae;,a of the      
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cfj;e-#a7 is       
amended-- 7#a7 in subsection 7a77#c7--  
7,a7 by redesignating subparagraphs 7,b7
 through 7,d7 as subparagraphs 7,d7     
through 7,f71 respectively2  7,b7 by    
inserting after subparagraph 7,a7 the   
following3  7,b7 an assessment of       
pediatric device labeling needs1 based  
on a review of real world evidence on   

the off-label use of medical devices in 
children1 drawn from data available to  
the ,food and ,drug ,administration2    
7,c7 the number of devices that receive 
a humanitarian use exemption under      
section #ebj7m72  2  7,c7 in            
subparagraph 7,e7 7as so redesignated71 
by striking 2 and and inserting 22  7,d7
 in subparagraph 7,f7 7as so            
redesignated71 by striking 7,b71 and    
7,c74 and inserting 7,c71 7,d71 and     
7,e72 and2 and  7,e7 by adding at the   
end the following3  7,g7 the number of  
devices for which extrapolation was used
 to support the approval of pediatric   
labeling of such devices4  ,for the     
items described in this paragraph1 such 
report shall disaggregate the number of 
devices by pediatric subpopulation4 2   
7#b7 by redesignating subsection 7c7 as 
subsection 7d72 and  7#c7 by inserting  
after subsection 7b71 the following3    
7c7 ,pediatric device innovation  7#a7  
,in general ,the ,secretary shall1 not  
later than #a year after the date of    

enactment of the ,pediatric ,device     
,development ,act1 establish within the 
,center for ,devices and ,radiological  
,health a structure to--  7,a7 provide  
assistance to device manufacturers1 in  
coordination with the relevant review   
committees1 as appropriate1 that would  
result in the development1 approval1 and
 labeling of medical devices for        
children2  7,b7 oversee an internal     
pediatrics team that-- 7i7 is comprised 
of--  7,i7 employees of the ,food and   
,drug ,administration with expertise in 
pediatrics and appropriate expertise    
pertaining to the relevant devices under
 review2 and  7,,ii7 other individuals  
designated by the ,secretary2 and  7ii7 
provides expertise and consultation on--
  7,i7 the application of subsection    
7b71 section #ebj7m71 section #eaj7k71  
and section #ebb of this ,act and       
section #djb of the ,public ,health     
,service ,act to pediatric devices2 and 
7,,ii7 pediatrics1 as it pertains to    
reviewing devices1 to all applicable    

divisions within the ,center for        
,devices and ,radiological ,health2     
7,c7 coordinate pediatric activities    
within the ,center for ,devices and     
,radiological ,health2 and  7,d7        
collaborate with other programs1        
offices1 and centers of the ,food and   
,drug ,administration1 including the    
consortia program authorized under      
section #cje of the ,pediatric ,medical 
,device ,safety and ,improvement ,act of
 #bjjg4  7#b7 ,staff ,such structure    
shall include a chief pediatric medical 
officer and other appropriate           
individuals as the ,secretary determines
 necessary4  4  #c4 ,humanitarian device
 exemption ,section #ebj7m7 of the      
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cfj;j7m77 is       
amended-- 7#a7 in paragraph 7#d7--  7,a7
 by striking an institutional review    
committee each place such term appears  
and inserting an institutional review   
board or an appropriate local committee2
 and  7,b7 by striking the institutional

 review committee and inserting the     
institutional review board or the       
appropriate local committee2 and  7#b7  
in paragraph 7#f77;,a77iv71 by striking 
#bjag and inserting #bjbb4  #d4         
,demonstration grants for improving     
pediatric availability ,section #cje of 
the ,pediatric ,medical ,device ,safety 
and ,improvement ,act of #bjjg 7,public 
,law #aaj-he2 #db ,u4,s4,c4 #bhb note7  
is amended--  7#a7 in subsection 7c7--  
7,a7 in paragraph 7#d71 by striking and 
at the end2  7,b7 in paragraph 7#e71 by 
striking the period and inserting 2 and2
 and  7,c7 by adding at the end the     
following3  7#f7 providing regulatory   
consultation to device sponsors in      
support of the submission of an         
application for a pediatric device1     
where appropriate4  2 and  7#b7 in      
subsection 7e71 by striking #bjag and   
inserting #bjbb4  #e4 ,meeting on       
pediatric device development  7a7 ,in   
general ,not later than #a year after   
the date of enactment of this ,act1 the 

,secretary of ,health and ,human        
,services shall convene a public meeting
 regarding opportunities and barriers to
 the development1 approval1 and labeling
 of pediatric medical devices4 ,such    
meeting shall include representatives   
from the medical device industry1       
academia1 recipients of funding under   
section #cje of the ,pediatric ,medical 
,device ,safety and ,improvement ,act of
 #bjjg 7,public ,law #aaj-he2 #db       
,u4,s4,c4 #bhb note71 medical provider  
organizations1 and organizations        
representing patients and consumers4    
7b7 ,topics ,the meeting described in   
subsection 7a7 shall include            
consideration of ways to-- 7#a7 improve 
research infrastructure and research    
networks to facilitate the conduct of   
clinical studies of devices for children
 that would result in the approval and  
labeling of medical devices for         
children2  7#b7 appropriately use       
extrapolation under section #eae;,a7b7  
of the ,federal ,food1 ,drug1 and       

,cosmetic ,act 7#ba ,u4,s4,c4           
#cfj;e-#a7;b772  7#c7 enhance the       
appropriate use of postmarket registries
 and data to increase pediatric medical 
device labeling2  7#d7 increase ,food   
and ,drug ,administration assistance to 
medical device manufacturers in         
developing devices for children that are
 approved and labeled for their use2 and
  7#e7 identify current barriers to     
pediatric device development and        
incentives to address such barriers4    
7c7 ,report ,not later than #f months   
after the meeting described in          
subsection 7a71 the ,secretary of       
,health and ,human ,services shall      
submit to the ,committee on ,energy and 
,commerce of the ,house of              
,representatives and the ,committee on  
,health1 ,education1 ,labor1 and        
,pensions of the ,senate1 and publish1  
including on the ,internet website of   
the ,food and ,drug ,administration1 a  
report that summarizes and responds to  
the recommendations raised in such      

meeting4