,i  #aaeth ,,congress  #ast ,session    
,h4 ,r4 #badd  ,,in ,,the ,,house ,,of  
,,representatives  ,april #be1          
#bjag,mrs4 ,mimi ,walters of ,california
 7for herself and ,ms4 ,kuster of ,new  
,hampshire7 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 provide for
 the appropriate1 risk-based            
classification of device accessories    
based on their intended uses4  #a4      
,short title  7a7 ,short title ,this    
,act may be cited as the ,risk-,based   
,classification of ,accessories ,act of 
#bjag4  7b7 ,findings ,the ,congress    
finds that there is a need for an       
appropriate process for the timely      
classification of device accessories1 in
 accordance with the #bast ,century     
,cures ,act 7,public ,law #aad-bee71    
such that accessories are classified in 
accordance with their intended uses4    
#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 to read as follows3  7#i7  7,a7 
,subject to the succeeding subparagraphs
 of this paragraph1 the ,secretary shall
 classify an accessory under this       
section based on the intended use of the
 accessory1 notwithstanding the         
classification of any other device with 
which such accessory is intended to be  
used4  7,b7 ,in the case of an accessory
 that1 as of ,december #ac1 #bjaf1 has  
been classified in accordance with      
subparagraph 7,a71 such classification  
shall continue to apply to such         
accessory4  7,c7  7i7 ,in the case of an
 accessory that has been cleared under  
section #eaj7k7 or approved under       
section #eae based on the classification
 of another device with which such      
accessory is intended to be used1 and   
the ,secretary has established a        
classification for such accessory in    
accordance with subparagraph 7,a71 the  

manufacturer of such accessory may1 in  
lieu of submitting a request for        
classification of such accessory1 submit
 a written notification to the          
,secretary identifying such             
classification4  7ii7 ,unless the       
,secretary1 not later than #cj days     
after receiving a notification under    
clause 7i71 informs the manufacturer    
involved that the ,secretary does not   
agree that the classification identified
 in such notification is appropriate for
 the accessory1 the accessory shall be  
automatically reclassified in the       
classification so identified4  7,d7  7i7
 ,in the case of a device intended to be
 used with an accessory that has not    
been classified by the ,secretary in    
accordance with subparagraph 7,a71 the  
person filing an application for        
premarket approval of such device under 
section #eae or a report under section  
#eaj7k7 for clearance of such device1   
may1 at the time such application or    
report 7as applicable7 is filed1 include

 with such application--  7,i7 a        
recommendation for the proper           
classification of the accessory pursuant
 to such subparagraph2 and  7,,ii7 such 
appropriate information to support the  
recommendation as may be specified by   
the ,secretary4  7ii7 ,the ,secretary's 
response under section #eae7;d7 or      
section #eaj7n7 7as applicable7 to an   
application or report described in      
clause 7i7 shall also contain the       
,secretary's approval or denial of the  
proposed classification of the accessory
 involved4  7iii7 ,the ,secretary's     
evaluation of an accessory under clause 
7i7 shall constitute an order           
establishing a new classification for   
such accessory for the specified        
intended use or uses of such accessory  
and for any accessory with the same     
intended use or uses as such accessory4 
7,e7  7i7 ,a manufacturer of an         
accessory that has been previously      
classified by the ,secretary based on   
the intended use of another device with 

which such accessory is intended to be  
used1 through the approval of such other
 device under section #eae7;c71 the     
clearance of such device under section  
#eaj7k71 or the submission of a petition
 for classification under section       
#eac7;f77#b71 and that has not been     
classified by the ,secretary in         
accordance with subparagraph 7,a71 may  
make a written submission to the        
,secretary containing a recommendation  
for the appropriate classification of   
the accessory based on the intended use 
or uses of the accessory4 ,such         
submission may include appropriate      
information to support the              
recommendation as may be specified by   
the ,secretary4  7ii7 ,the ,secretary   
shall respond to a submission made under
 clause 7i7 not later than #fj days     
after receiving such submission by      
approving or denying the recommended    
classification of the accessory4 ,the   
,secretary shall provide an opportunity 
for a manufacturer to meet with         

appropriate personnel of the ,food and  
,drug ,administration to discuss the    
appropriate classification of such      
accessory prior to making a written     
submission4  7,f7 ,nothing in this      
paragraph may be construed as precluding
 a manufacturer of an accessory from    
using the classification process        
described in section subsection 7f77#b7 
to obtain classification of such        
accessory4  4  #c4 ,effective date ,the 
amendment made by section #b shall take 
effect on the date that is #fj days     
after the date of the enactment of this 
,act4