,,ii  #aaeth ,,congress  #ast ,session  
,s4 #ajgj  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,may #h1 #bjag 
,mr4 ,roberts 7for himself1 ,mr4        
,donnelly1 and ,mr4 ,burr7 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 provide for the appropriate1    
risk-based classification of device     
accessories based on intended use4  #a4 
,short title  ,this ,act may be cited as
 the ,realizing ,intended ,safety for   
,certain ,accessories ,act of #bjag4    
#b4 ,risk-based classification of       
accessories ,section #eac7;b77#i7 of the
 ,federal ,food1 ,drug1 and ,cosmetic   
,act 7#ba ,u4,s4,c4 #cfj;c7b77#i77 is   
amended-- 7#a7 by striking 7#i7 ,the    
,secretary and inserting 7#i77;,a7 ,the 
,secretary2 and  7#b7 by adding at the  
end the following3  7,b7 ,the           
classification of any accessory         

classified prior to ,december #ac1      
#bjaf1 based on the intended use or uses
 of such accessory1 shall continue to   
apply1 notwithstanding the              
classification of any other device with 
which such accessory is intended to be  
used4  7,c7 7i7 ,if-- 7,i7 an accessory 
has been cleared or approved based on   
the classification of another device    
with which such accessory is intended to
 be used2 and  7,,ii7 the ,secretary has
 established a classification for such  
accessory based on the intended use or  
uses of the accessory1 in accordance    
with subparagraph 7,a71  the            
manufacturer of such accessory may      
identify the classification described in
 subclause 7,,ii7 in a written          
notification to the ,secretary4  7ii7   
,unless the ,secretary notifies a       
manufacturer within #cj calendar days of
 receipt of a written notification      
described in clause 7i7 that the        
,secretary does not agree that the      
classification identified in such       

written notification is appropriate for 
the accessory1 the accessory shall be   
automatically reclassified in accordance
 with the classification identified in  
such written notification4  7iii7 ,a    
written notification that the ,secretary
 disagrees with the classification      
identified in a written notification    
described in clause 7ii7 shall include a
 detailed description and justification 
for the determination to disagree4  7,d7
 7i7 ,a manufacturer of an accessory    
that has been previously classified by  
the ,secretary based on the intended use
 of another device with which the       
accessory is intended to be used1       
through an application for such other   
device under section #eae7;c71 a report 
under section #eaj7k71 or a petition for
 classification under section           
#eac7;f77#b71 and that has not been     
classified by the ,secretary based on   
the intended use or uses of the         
accessory as described in subparagraph  
7,a7 or 7,c71 may submit to the         

,secretary a written recommendation for 
the appropriate classification of such  
accessory based on its intended use or  
uses4 ,such submission shall include    
such information to support the         
recommendation as the ,secretary may    
require4  7ii7 ,the ,secretary shall    
respond to a submission under clause 7i7
 within #fj calendar days by approving  
or denying the recommended              
classification of the accessory4 ,if the
 ,secretary does not agree with the     
recommendation for classification       
submitted by the sponsor1 the response  
shall include a detailed description and
 justification for such determination to
 disagree4 ,the ,secretary shall provide
 an opportunity for a manufacturer to   
meet with appropriate personnel to      
discuss appropriate classification of   
such accessory prior to submitting a    
written recommendation4  7,e7 ,at the   
time a sponsor submits an application   
for premarket approval for a class ,,iii
 device pursuant to section #eae7;c71   

the sponsor of such application may     
include a recommendation and supporting 
information for the proper              
classification of such accessory        
pursuant to subparagraph 7,a74 ,if such 
device is intended to be used with an   
accessory that has not been classified  
by the ,secretary based on its intended 
use or uses as described in subparagraph
 7,a7 or 7,c71 the ,secretary shall--   
7i7 approve or deny the application     
pursuant to section #eae7;d72 and  7ii7 
approve or deny the classification of   
the accessory proposed in the           
application submitted under this clause4
  7,f7 ,a manufacturer may at any time  
use the classification process described
 in section #eac7;f77#b7 to obtain      
classification of an accessory4  4