,i  #aai? ,,congress  #a/ ,session  ,h4 
,r4 #aeci  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,febru>y #bd1         
#bjbe,mr4 ,ob]nolte 7= himself1 ,mr4    
,mull91 ,mr4 ,cr5%aw1 & ,ms4 ,craig7    
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,en]gy & ,comm]ce  ,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+ is readily    
accessible to int5d$ us]s ( su* devices2
  7,b7 ! manufactur] af=ds int5d$ us]s (
 su* devices ! opportunity to reque/ !  
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 ,) respect to     
devices = :i* label+ is made available  
solely by electronic means1 ! ,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 device type4  7,b7    
,not)/&+ sub*apt] ,,ii ( *apt] #e (     
title #e1 ,unit$ ,/ates ,code1 su* ord] 
%all be publi%$ 9 ! ,f$]al ,regi/]1     
foll[+ publication ( a propos$ ord] 9 ! 
,f$]al ,regi/] & consid]ation ( comm5ts 
to a public docket4  7,c7 ,su* ord] may 
require ! label ( a device to conta9    
c]ta9 in=mation or comply ) c]ta9       
conditions only if ! ,secret>y det]m9es 
su* requirem5t is necess>y to provide a 
reasonable assurance ( ! safety &       
effectiv5ess ( ! device4  4