,,ii  #aaith ,,congress  #b;d ,session  
,s4 #deai  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,may #ac1      
#bjbf,mr4 ,banks 7for himself and ,mr4  
,hickenlooper7 introduced the following 
bill2 which was read twice and referred 
to the ,committee on ,health1           
,education1 ,labor1 and ,pensions  ,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 complies with all     
applicable requirements of law and the  
manufacturer provides intended users of 
such devices with easy and user-friendly
 access to such labeling2  7,b7 the     
manufacturer affords intended users of  
such devices the opportunity to request1

 through easily accessible mechanisms   
for making such request1 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 ,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 device4  7,b7 ,an order    
under clause 7,a7 establishing a        
requirement in addition to the          
requirements under subparagraph 7#b7 may
 be issued if the ,secretary determines 
that-- 7i7 such additional requirement  
is necessary to ensure that the label of
 a device intended for use by patients  
without provider supervision contains   

certain information or complies with    
certain conditions2 or  7ii7 making     
labeling available solely by electronic 
means would not be sufficient to provide
 a reasonable assurance of the safety   
and effectiveness of the device4  7,c7  
,an order under clause 7,a7 establishing
 an exception from the requirements     
under subparagraph 7#b7 shall contain a 
detailed description of which           
requirement the exception applies to and
 the justification for the exception4   
7,d7 ,notwithstanding subchapter ,,ii of
 chapter #e of title #e1 ,united ,states
 ,code1 an order under this subparagraph
 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  4  #c4 ,request for     
information and public comment ,not     
later than #b years after the date of   
enactment of this ,act1 the ,secretary  
of ,health and ,human ,services1 acting 
through the ,commissioner of ,food and  

,drugs1 shall post a request for        
information including a public docket in
 the ,federal ,register and on a        
publicly accessible website of the      
,department of ,health and ,human       
,services enabling stakeholders to      
submit comments on how to continue to   
optimize the format1 accessibility1 and 
usability of electronic labeling of     
devices other than prescription devices 
intended for use in health care         
facilities or by a health care          
professional and in vitro diagnostic    
devices intended for use by health care 
professionals or in blood               
establishments4