,,ii  #aag? ,,congress  #b;d ,session   
,s4 #cihc  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,m>* #ca1 #bjbb,mr4    
,cassidy 7= himself & ,ms4 ,baldw97     
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to am5d ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act to require1 =   
purposes ( ensur+ cyb]security1 !       
inclusion 9 any prem>ket submission = a 
cyb] device ( in=mation to demon/rate a 
reasonable assurance ( safety &         
effectiv5ess ?r\gh\t ! lifecycle ( !    
cyb] device1 & = o!r purposes4  #a4     
,%ort title ,?is ,act may be cit$ z !   
,,pat* ,act4  #b4 ,ensur+ cyb]security (
 m$ical devices  7a7 ,9 g5]al ,sub*apt] 
,a ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 &
 ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et  
seq47 is am5d$ by add+ at ! end !       
foll[+3  #ebd;,b4 ,ensur+ cyb]security (
 devices  7a7 ,9 g5]al ,= purposes (    
ensur+ cyb]security ?r\gh\t ! lifecycle 
( a cyb] device1 any p]son :o submits a 

prem>ket submission = ! cyb] device %all
 include su* in=mation z ! ,secret>y may
 require to ensure t ! cyb] device meets
 su* cyb]security requirem5ts z !       
,secret>y det]m9es to be appropriate to 
demon/rate a reasonable assurance (     
safety & effectiv5ess1 includ+ at a     
m9imum ! cyb]security requirem5ts "u    
subsection 7b74 ,! ,secret>y may e/abli%
 exemptions to ! requirem5ts "u ?is     
subsection4  7b7 ,cyb]security          
requirem5ts ,at a m9imum1 ! manufactur] 
( a cyb] device %all meet ! foll[+      
cyb]security requirem5ts3 7#a7 ,!       
manufactur] %all h a plan to            
appropriately monitor1 id5tify1 &       
address 9 a reasonable "t po/m>ket      
cyb]security vuln]abilities & exploits4 
7#b7 ,! manufactur] %all-- 7,a7 h a plan
 & proc$ures = a ,coord9at$             
,vuln]ability ,disclosure to be "p (    
submissions to ! ,food & ,drug          
,adm9i/ration2 &  7,b7 collect & ma9ta9 
su* o!r in=mation z ! ,secret>y may 7by 
ord] publi%$ 9 ! ,f$]al ,regi/] or by   

o!r process7 require to demon/rate a    
reasonable assurance ( ! safety &       
effectiv5ess ( ! cyb] device4  7#c7 ,!  
manufactur] %all design1 develop1 &     
ma9ta9 processes & proc$ures to make    
available updates & pat*es to ! cyb]    
device & relat$ sy/ems ?r\gh\t !        
lifecycle ( ! cyb] device to address--  
7,a7 on a reasonably ju/ifi$ regul>     
cycle1 kn[n unacceptable vuln]abilities2
 &  7,b7 z soon z possible out ( cycle1 
critical vuln]abilities t c\ld cause    
uncontroll$ risks4  7#d7 ,! manufactur] 
%all furni% to ! ,secret>y a s(tw>e bill
 ( mat]ials1 includ+ comm]cial1         
op5-s\rc$1 & (f-!-%elf s(tw>e compon5ts 
t w be provid$ to us]s4  7c7 ,sub/antial
 equival5ce ,9 mak+ a det]m9ation (     
sub/antial equival5ce "u section        
#eac7;i7 = a cyb] device1 ! ,secret>y   
may-- 7#a7 f9d t cyb]security in=mation 
= ! cyb] device describ$ 9 ! relevant   
prem>ket submission 9 ! cyb] device's   
use environm5t is inadequate2 &  7#b7   
issue a nonsub/antial equival5ce        

det]m9ation bas$ on ?is f9d+4  7d7      
,def9ition ,9 ?is section3 7#a7 ,! t]m  
cyb] device means a device t-- 7,a7     
includes s(tw>e2 or  7,b7 is int5d$ to  
connect to ! int]net4  7#b7 ,! t]m      
lifecycle ( ! cyb] device includes !    
po/m>ket lifecycle ( ! cyb] device4     
7#c7 ,! t]m prem>ket submission means   
any submission "u section #eaj7k71 #eac1
 #eae7;c71 #eae7;f71 or #ebj7m74  4  7b7
 ,prohibit$ act ,section #cja7q7 ( !    
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cca7q77 is am5d$ by add+
 at ! end ! foll[+3  7#c7 ,! failure to 
comply ) any requirem5t "u section      
#ebd;,b 7relat+ to ensur+ !             
cyb]security74  4  7c7 ,adult]ation     
,section #eja ( ! ,f$]al ,food1 ,drug1 &
 ,cosmetic ,act 7#ba ,u4,s4,c4 #cea7 is 
am5d$ by add+ at ! end ! foll[+3  7k7   
,if x is a device ) respect to :i* !    
sponsor is 9 violation ( section #ebd;,b
 7relat+ to ensur+ cyb]security74  4    
7d7 ,misbr&+ ,section #ejb7t7 ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    

,u4,s4,c4 #ceb7t77 is am5d$-- 7#a7 by   
/rik+ or 7#c7 & ins]t+ 7#c72 &  7#b7 by 
ins]t+ be=e ! p]iod at ! end ! foll[+3 1
 or 7#d7 to furni% a s(tw>e bill (      
mat]ials z requir$ "u section #ebd;,b   
7relat+ to ensur+ ! cyb]security74