,,ii  #aagth ,,congress  #b;d ,session  
,s4 #cdgg  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,january #aa   
7legislative day1 ,january #aj71        
#bjbb,mr4 ,casey 7for himself and ,ms4  
,collins7 introduced the following bill2
 which was read twice and referred to   
the ,committee on ,health1 ,education1  
,labor1 and ,pensions  ,a ,,bill  ,to   
improve the program for reporting on    
device shortages4  #a4 ,short title     
,this ,act may be cited as the          
,planning1 ,reporting1 and ,enabling    
,voluntary ,expansion of ,notifications 
,targeting ,medical ,device ,shortages  
,act of #bjbb or the ,,prevent ,medical 
,device ,shortages ,act of #bjbb4  #b4  
,preventing medical device shortages    
7a7 ,notifications  7#a7 ,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 7a71 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 device and other   
devices that could reasonably be        
substituted for that device in the      
,united ,states before the period2  7,b7
 in subsection 7f71 by inserting or 7h7 
after subsection 7a72  7,c7 by          
redesignating subsections 7h7 and 7i7 as
 subsections 7j7 and 7k71 respectively2 
and  7,d7 by inserting after subsection 
7g7 the following3  7h7 ,additional     
notifications ,the ,secretary may       
receive 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  7i7    
,risk management plans ,each            
manufacturer of a device that is        
critical to the public health1 including
 devices that are life-supporting1      
life-sustaining1 or intended for use in 
emergency medical care or during        
surgery1 shall develop1 maintain1 and1  
as appropriate1 implement a redundancy  
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 #a device           
manufactured at the same establishment2 
and  7#b7 shall be subject to inspection
 and copying1 both remotely and         
physically1 by the ,secretary pursuant  
to section #gjd or at the request of the

 ,secretary4  4  7#b7 ,report ,not later
 than #a year after the date of         
enactment of this ,act1 and annually for
 #d years thereafter1 the ,secretary of 
,health and ,human ,services 7referred  
to in this section as the ,secretary7   
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 or applicable guidance4  7#c7   
,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 7h7 of   
section #ejf;,j of the ,federal ,food1  
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4

 #cef;j71 as added by paragraph 7#a74   
,such guidance shall include a          
description of circumstances in which a 
voluntary notification under such       
subsection 7h7 may be appropriate1      
recommended timeframes within which     
sponsors should 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