,i  #aaith ,,congress  #ast ,session    
,h4 ,r4 #aeci  ,,in ,,the ,,house ,,of  
,,representatives  ,february #bd1       
#bjbe,mr4 ,obernolte 7for himself1 ,mr4 
,mullin1 ,mr4 ,crenshaw1 and ,ms4       
,craig7 introduced the following bill2  
which was referred to the ,committee on 
,energy and ,commerce  ,a ,,bill  ,to   
amend the ,federal ,food1 ,drug1 and    
,cosmetic ,act to expand the types of   
devices for which required labeling may 
be made available solely by electronic  
means1 and for other purposes4  #a4     
,short title ,this ,act may be cited as 
the ,medical ,device ,electronic        
,labeling ,act4  #b4 ,allowing required 
labeling of devices to be made available
 solely by electronic means ,section    
#ejb7;f7 of the ,federal ,food1 ,drug1  
and ,cosmetic ,act 7#ba ,u4,s4,c4       
#ceb7;f77 is amended to read as follows3
  7f7  7#a7 ,unless its labeling bears  
7,a7 adequate directions for use2 and   
7,b7 such adequate warnings against use 
in those pathological conditions or by  

children where its use may be dangerous 
to health1 or against unsafe dosage or  
methods or duration of administration or
 application1 in such manner and form1  
as are necessary for the protection of  
users1 except that where any requirement
 of clause 7,a7 of this subparagraph1 as
 applied to any drug or device1 is not  
necessary for the protection of the     
public health1 the ,secretary shall     
promulgate regulations exempting such   
drug or device from such requirement4   
7#b7 ,subject to subparagraph 7#c71     
required labeling for devices 7including
 in vitro diagnostic devices7 may be    
made available solely by electronic     
means1 provided that--  7,a7 such       
required labeling is readily accessible 
to intended users of such devices2  7,b7
 the manufacturer affords intended users
 of such devices the opportunity to     
request the required labeling in paper  
form1 and upon such request1 promptly   
provides the requested information in   
paper form without additional cost2 and 

7,c7 the label affixed to the device or 
its immediate container includes all    
information in compliance with this ,act
 and the regulations thereunder or any  
applicable order of the ,secretary under
 subparagraph 7#c77;,a74  7#c7 7,a7     
,with respect to devices for which      
labeling is made available solely by    
electronic means1 the ,secretary may    
issue an order establishing requirements
 in addition to1 or exceptions from1 the
 requirements under subparagraph 7#b7   
for the label affixed to a device type4 
7,b7 ,notwithstanding subchapter ,,ii of
 chapter #e of title #e1 ,united ,states
 ,code1 such order shall be published in
 the ,federal ,register1 following      
publication of a proposed order in the  
,federal ,register and consideration of 
comments to a public docket4  7,c7 ,such
 order may require the label of a device
 to contain certain information or      
comply with certain conditions only if  
the ,secretary determines such          
requirement is necessary to provide a   

reasonable assurance of the safety and  
effectiveness of the device4  4