,,ii  #aai? ,,congress  #b;d ,session   
,s4 #deai  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,may #ac1 #bjbf,mr4    
,banks 7= himself & ,mr4 ,hick5loop]7   
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to am5d ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act to exp& ! types 
( devices = :i* requir$ label+ may be   
made available solely by electronic     
means1 & = o!r purposes4  #a4 ,%ort     
title ,?is ,act may be cit$ z ! ,m$ical 
,device ,electronic ,label+ ,act4  #b4  
,all[+ requir$ label+ ( devices to be   
made available solely by electronic     
means ,section #ejb7;f7 ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #ceb7;f77 is am5d$ to read z  
foll[s3  7f7 7#a7 ,unless its label+    
be>s 7,a7 adequate directions = use2 &  
7,b7 su* adequate w>n+s aga9/ use 9 ^?  
pa?ological conditions or by *ildr5 :]e 
its use may be dang]\s to heal?1 or     
aga9/ unsafe dosage or me?ods or        

duration ( adm9i/ration or application1 
9 su* mann] & =m1 z are necess>y = !    
protection ( us]s1 except t :]e any     
requirem5t ( clause 7,a7 ( ?is          
subp>agraph1 z appli$ to any drug or    
device1 is n necess>y = ! protection ( !
 public heal?1 ! ,secret>y %all         
promulgate regulations exempt+ su* drug 
or device f su* requirem5t4  7#b7       
,subject to subp>agraph 7#c71 requir$   
label+ = devices 7includ+ 9 vitro       
diagno/ic devices7 may be made available
 solely by electronic means1 provid$ t--
 7,a7 su* requir$ label+ complies ) all 
applicable requirem5ts ( law & !        
manufactur] provides int5d$ us]s ( su*  
devices ) easy & us]-fri5dly access to  
su* label+2  7,b7 ! manufactur] af=ds   
int5d$ us]s ( su* devices ! opportunity 
to reque/1 ?r\gh easily accessible      
me*anisms = mak+ su* reque/1 ! requir$  
label+ 9 pap] =m1 & ^u su* reque/1      
promptly provides ! reque/$ in=mation 9 
pap] =m )\t additional co/2 &  7,c7 !   
label affix$ to ! device or its imm$iate

 conta9] includes all in=mation 9       
compliance ) ?is ,act & ! regulations   
!reund] or any applicable ord] ( !      
,secret>y "u subp>agraph 7#c77;,a74     
7#c7 7,a7 ,! ,secret>y may issue an ord]
 e/abli%+ requirem5ts 9 addition to1 or 
exceptions f1 ! requirem5ts "u          
subp>agraph 7#b7 = ! label affix$ to a  
device4  7,b7 ,an ord] "u clause 7,a7   
e/abli%+ a requirem5t 9 addition to !   
requirem5ts "u subp>agraph 7#b7 may be  
issu$ if ! ,secret>y det]m9es t-- 7i7   
su* additional requirem5t is necess>y to
 ensure t ! label ( a device int5d$ =   
use by pati5ts )\t provid] sup]vision   
conta9s c]ta9 in=mation or complies )   
c]ta9 conditions2 or  7ii7 mak+ label+  
available solely by electronic means    
w\ld n be suffici5t to provide a        
reasonable assurance ( ! safety &       
effectiv5ess ( ! device4  7,c7 ,an ord] 
"u clause 7,a7 e/abli%+ an exception f !
 requirem5ts "u subp>agraph 7#b7 %all   
conta9 a detail$ description ( :i*      
requirem5t ! exception applies to & !   

ju/ification = ! exception4  7,d7       
,not)/&+ sub*apt] ,,ii ( *apt] #e (     
title #e1 ,unit$ ,/ates ,code1 an ord]  
"u ?is subp>agraph %all be publi%$ 9 !  
,f$]al ,regi/]1 foll[+ publication ( a  
propos$ ord] 9 ! ,f$]al ,regi/] &       
consid]ation ( comm5ts to a public      
docket4  4  #c4 ,reque/ = in=mation &   
public comm5t ,n lat] ?an #b ye>s aft] !
 date ( enactm5t ( ?is ,act1 ! ,secret>y
 ( ,heal? & ,human ,s]vices1 act+ ?r\gh 
! ,commission] ( ,food & ,drugs1 %all   
po/ a reque/ = in=mation includ+ a      
public docket 9 ! ,f$]al ,regi/] & on a 
publicly accessible website ( !         
,dep>tm5t ( ,heal? & ,human ,s]vices    
enabl+ /akehold]s to submit comm5ts on  
h[ to cont9ue to optimize ! =mat1       
accessibility1 & usability ( electronic 
label+ ( devices o!r ?an prescription   
devices int5d$ = use 9 heal? c>e        
facilities or by a heal? c>e pr(essional
 & 9 vitro diagno/ic devices int5d$ =   
use by heal? c>e pr(essionals or 9 blood
 e/abli%m5ts4