,,ii  #aag? ,,congress  #b;d ,session   
,s4 #cdgg  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,janu>y #aa            
7legislative day1 ,janu>y #aj71         
#bjbb,mr4 ,casey 7= himself & ,ms4      
,coll9s7 introduc$ ! foll[+ bill2 :i* 0 
read twice & ref]r$ to ! ,committee on  
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to improve ! program =      
report+ on device %ortages4  #a4 ,%ort  
title ,?is ,act may be cit$ z ! ,plann+1
 ,report+1 & ,enabl+ ,volunt>y          
,expansion ( ,notifications ,t>get+     
,m$ical ,device ,%ortages ,act ( #bjbb  
or ! ,,prev5t ,m$ical ,device ,%ortages 
,act ( #bjbb4  #b4 ,prev5t+ m$ical      
device %ortages  7a7 ,notifications     
7#a7 ,9 g5]al ,section #ejf;,j ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cef;j7 is am5d$-- 7,a7 9
 ! flu% text at ! end ( subsection 7a71 
by ins]t+ or ( any o!r circum/ance t is 
likely to lead to a mean+ful disruption 
9 ! supply ( ! device or a %ortage ( !  
device & o!r devices t c\ld reasonably  

be sub/itut$ = t device 9 ! ,unit$      
,/ates be=e ! p]iod2  7,b7 9 subsection 
7f71 by ins]t+ or 7h7 aft] subsection   
7a72  7,c7 by r$esignat+ subsections 7h7
 & 7i7 z subsections 7j7 & 7k71         
respectively2 &  7,d7 by ins]t+ aft]    
subsection 7g7 ! foll[+3  7h7           
,additional notifications ,! ,secret>y  
may receive notifications f a           
manufactur] ( a device t is             
life-support+1 life-su/a9+1 or int5d$ = 
use 9 em]g5cy m$ical c>e or dur+ surg]y1
 or any o!r device ! ,secret>y det]m9es 
to be critical to ! public heal?1 p]ta9+
 to a p]man5t discont9uance 9 !         
manufacture ( ! device 7except = any    
discont9uance z a result ( an approv$   
modification ( ! device7 or an          
int]ruption ( ! manufacture ( ! device t
 is likely to lead to a mean+ful        
disruption 9 ! supply ( t device 9 !    
,unit$ ,/ates1 & ! reasons = su*        
discont9uance or int]ruption4  7i7 ,risk
 managem5t plans ,ea* manufactur] ( a   
device t is critical to ! public heal?1 

includ+ devices t are life-support+1    
life-su/a9+1 or int5d$ = use 9 em]g5cy  
m$ical c>e or dur+ surg]y1 %all develop1
 ma9ta91 &1 z appropriate1 implem5t a   
r$undancy risk managem5t plan t         
id5tifies & evaluates risks to ! supply 
( ! device1 z applicable1 = ea*         
e/abli%m5t 9 :i* su* device is          
manufactur$4 ,a risk managem5t plan "u  
?is subsection-- 7#a7 may id5tify &     
evaluate risks to ! supply ( m ?an #a   
device manufactur$ at ! same e/abli%m5t2
 &  7#b7 %all be subject to inspection &
 copy+1 bo? remotely & physically1 by ! 
,secret>y pursuant to section #gjd or at
 ! reque/ ( ! ,secret>y4  4  7#b7       
,report ,n lat] ?an #a ye> aft] ! date (
 enactm5t ( ?is ,act1 & annually = #d   
ye>s !reaft]1 ! ,secret>y ( ,heal? &    
,human ,s]vices 7ref]r$ to 9 ?is section
 z ! ,secret>y7 %all prep>e & submit to 
! ,committee on ,heal?1 ,education1     
,labor1 & ,p5sions ( ! ,s5ate & !       
,committee on ,en]gy & ,comm]ce ( !     
,h\se ( ,repres5tatives a report on !   

use ( in=mation manufactur]s submit     
pursuant to section #ejf;,j ( ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cef;j7 or applicable         
guidance4  7#c7 ,guidance on volunt>y   
notifications ( discont9uance or        
int]ruption ( device manufacture ,n lat]
 ?an #a ye> aft] ! date ( enactm5t ( ?is
 ,act1 ! ,secret>y %all issue draft     
guidance to facilitate volunt>y         
notifications "u subsection 7h7 (       
section #ejf;,j ( ! ,f$]al ,food1 ,drug1
 & ,cosmetic ,act 7#ba ,u4,s4,c4        
#cef;j71 z add$ by p>agraph 7#a74 ,su*  
guidance %all include a description (   
circum/ances 9 :i* a volunt>y           
notification "u su* subsection 7h7 may  
be appropriate1 recomm5d$ timeframes )9 
:i* sponsors %\ld submit su* a          
notification1 ! process = receiv+ su*   
notifications1 & actions ! ,secret>y may
 take to mitigate or prev5t a %ortage   
result+ f a discont9uance or int]ruption
 9 ! manufacture ( a device = :i* su*   
notification is receiv$4 ,! ,secret>y   

%all issue f9al guidance n lat] ?an #a  
ye> aft] ! close ( ! comm5t p]iod = !   
draft guidance4