,,ii  #aagth ,,congress  #b;d ,session  
,s4 #chcd  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,march #ad1    
#bjbb,mr4 ,braun 7for himself 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 strengthen medical device   
supply chains4  #a4 ,strengthening      
medical device supply chains  7a7 ,in   
general ,section #ejf;,j of the ,federal
 ,food1 ,drug1 and ,cosmetic ,act 7#ba  
,u4,s4,c4 #cef;j7 is amended-- 7#a7 in  
the flush text at the end of subsection 
7a7-- 7,a7 by inserting or of any other 
circumstance that is likely to lead to a
 meaningful disruption in the supply of 
the device or a shortage of the device1 
and there is no other available device  
that could reasonably be substituted for
 that device in the ,united ,states     
before the period2 and  7,b7 by adding  
at the end the following3 ,the          
,secretary shall develop and publish a  

list of device product codes required to
 comply with this subsection1 and update
 the list every #c years1 or in response
 to a public health emergency42  7#b7 by
 redesignating subsections 7h7 and 7i7  
as subsections 7j7 and 7k71             
respectively2  7#c7 by inserting after  
subsection 7g7 the following3  7h7 ,risk
 management plans ,each manufacturer of 
a device that is included on the list   
described in subsection 7a71 shall      
develop1 maintain1 and1 as appropriate1 
implement a risk management plan that   
identifies and evaluates risks to the   
supply of the device1 as applicable1 for
 each establishment in which such device
 is manufactured4 ,a risk management    
plan under this subsection-- 7#a7 may   
identify and evaluate risks to the      
supply of more than one device1 or      
device category1 manufactured at the    
same establishment2 and  7#b7 shall be  
subject to inspection and copying by the
 ,secretary pursuant to section #gjd or 
at the request of the ,secretary4  2    

7#d7 in subsection 7f71 by inserting or 
7i7 after subsection 7a72 and  7#e7 by  
inserting after subsection 7h71 as added
 by paragraph 7#c71 the following3  7i7 
,additional notifications ,the          
,secretary may receive voluntary        
notifications from a manufacturer of a  
device that is life-supporting1         
life-sustaining1 or intended for use in 
emergency medical care or during        
surgery1 or any other device the        
,secretary determines to be critical to 
the public health1 pertaining to a      
permanent discontinuance in the         
manufacture of the device 7except for   
any discontinuance as a result of an    
approved modification of the device7 or 
an interruption of the manufacture of   
the device that is likely to lead to a  
meaningful disruption in the supply of  
that device in the ,united ,states1 and 
the reasons for such discontinuance or  
interruption4  2 and  7#f7 in subsection
 7j7 7as so redesignated by paragraph   
7#b77-- 7,a7 by striking shall be       

construed to affect and inserting the   
following3 8shall be construed--  7#a7  
to affect  2  7,b7 by striking the      
period at the end and inserting 2 or2   
and  7,c7 by adding at the end the      
following3  7#b7 to grant the ,secretary
 the authority to-- 7,a7 require        
specific design1 management1            
implementation1 or updating of risk     
management plans2  7,b7 assess          
performance or compliance with a risk   
management plan1 under subsection 7h72  
or  7,c7 require notification under     
subsection 7i74  4  7b7 ,report ,not    
later than #b years after the date of   
enactment of this ,act1 and annually    
thereafter1 the ,secretary of ,health   
and ,human ,services shall prepare and  
submit to the ,committee on ,health1    
,education1 ,labor1 and ,pensions of the
 ,senate and the ,committee on ,energy  
and ,commerce of the ,house of          
,representatives a report on the use of 
information manufacturers submit        
pursuant to section #ejf;,j of the      

,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cef;j7 and         
applicable guidance issued with respect 
to such section1 and any actions taken  
by the ,secretary to mitigate or prevent
 a device shortage4  7c7 ,guidance on   
voluntary notifications of              
discontinuance or interruption of device
 manufacture ,not later than #a year    
after the date of enactment of this     
,act1 the ,secretary shall issue draft  
guidance to facilitate voluntary        
notifications under subsection 7i7 of   
section #ejf;,j of the ,federal ,food1  
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cef;j71 as added by subsection 7a74   
,such guidance shall include a          
description of circumstances in which a 
voluntary notification under such       
subsection 7i7 may be appropriate1      
recommended timeframes within which     
sponsors may submit such a notification1
 the process for receiving such         
notifications1 and actions the          
,secretary may take to mitigate or      

prevent a shortage resulting from a     
discontinuance or interruption in the   
manufacture of a device for which such  
notification is received4 ,the          
,secretary shall issue final guidance   
not later than #a year after the close  
of the comment period for the draft     
guidance4