,i  #aae? ,,congress  #a/ ,session  ,h4 
,r4 #badd  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,april #be1 #bjag,mrs4
 ,mimi ,walt]s ( ,cali=nia 7= h]self &  
,ms4 ,ku/] ( ,new ,hamp%ire7 introduc$ !
 foll[+ bill2 :i* 0 ref]r$ to !         
,committee on ,en]gy & ,comm]ce  ,a     
,,bill  ,to am5d ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act to provide = !         
appropriate1 risk-bas$ classification ( 
device accessories bas$ on _! int5d$    
uses4  #a4 ,%ort title  7a7 ,%ort title 
,?is ,act may be cit$ z ! ,risk-,bas$   
,classification ( ,accessories ,act (   
#bjag4  7b7 ,f9d+s ,! ,congress f9ds t  
!re is a ne$ = an appropriate process = 
! timely classification ( device        
accessories1 9 accordance ) ! #ba/      
,c5tury ,cures ,act 7,public ,law       
#aad-bee71 su* t accessories are        
classifi$ 9 accordance ) _! int5d$ uses4
  #b4 ,risk-bas$ classification (       
accessories ,section #eac7;b77#i7 ( !   
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cfj;c7b77#i77 is am5d$  

to read z foll[s3  7#i7  7,a7 ,subject  
to ! succe$+ subp>agraphs ( ?is         
p>agraph1 ! ,secret>y %all classify an  
accessory "u ?is section bas$ on !      
int5d$ use ( ! accessory1 not)/&+ !     
classification ( any o!r device ) :i*   
su* accessory is int5d$ to be us$4  7,b7
 ,9 ! case ( an accessory t1 z (        
,decemb] #ac1 #bjaf1 has be5 classifi$ 9
 accordance ) subp>agraph 7,a71 su*     
classification %all cont9ue to apply to 
su* accessory4  7,c7  7i7 ,9 ! case ( an
 accessory t has be5 cle>$ "u section   
#eaj7k7 or approv$ "u section #eae bas$ 
on ! classification ( ano!r device ) :i*
 su* accessory is int5d$ to be us$1 & ! 
,secret>y has e/abli%$ a classification 
= su* accessory 9 accordance )          
subp>agraph 7,a71 ! manufactur] ( su*   
accessory may1 9 lieu ( submitt+ a      
reque/ = classification ( su* accessory1
 submit a writt5 notification to !      
,secret>y id5tify+ su* classification4  
7ii7 ,unless ! ,secret>y1 n lat] ?an #cj
 days aft] receiv+ a notification "u    

clause 7i71 in=ms ! manufactur] involv$ 
t ! ,secret>y does n agree t !          
classification id5tifi$ 9 su*           
notification is appropriate = !         
accessory1 ! accessory %all be          
automatically reclassifi$ 9 !           
classification s id5tifi$4  7,d7  7i7 ,9
 ! case ( a device int5d$ to be us$ ) an
 accessory t has n be5 classifi$ by !   
,secret>y 9 accordance ) subp>agraph    
7,a71 ! p]son fil+ an application =     
prem>ket approval ( su* device "u       
section #eae or a report "u section     
#eaj7k7 = cle>ance ( su* device1 may1 at
 ! "t su* application or report 7z      
applicable7 is fil$1 include ) su*      
application--  7,i7 a recomm5dation = ! 
prop] classification ( ! accessory      
pursuant to su* subp>agraph2 &  7,,ii7  
su* appropriate in=mation to support !  
recomm5dation z may be specifi$ by !    
,secret>y4  7ii7 ,! ,secret>y's response
 "u section #eae7;d7 or section #eaj7n7 
7z applicable7 to an application or     
report describ$ 9 clause 7i7 %all also  

conta9 ! ,secret>y's approval or d5ial (
 ! propos$ classification ( ! accessory 
involv$4  7iii7 ,! ,secret>y's          
evaluation ( an accessory "u clause 7i7 
%all con/itute an ord] e/abli%+ a new   
classification = su* accessory = !      
specifi$ int5d$ use or uses ( su*       
accessory & = any accessory ) ! same    
int5d$ use or uses z su* accessory4     
7,e7  7i7 ,a manufactur] ( an accessory 
t has be5 previ\sly classifi$ by !      
,secret>y bas$ on ! int5d$ use ( ano!r  
device ) :i* su* accessory is int5d$ to 
be us$1 ?r\gh ! approval ( su* o!r      
device "u section #eae7;c71 ! cle>ance (
 su* device "u section #eaj7k71 or !    
submission ( a petition = classification
 "u section #eac7;f77#b71 & t has n be5 
classifi$ by ! ,secret>y 9 accordance ) 
subp>agraph 7,a71 may make a writt5     
submission to ! ,secret>y conta9+ a     
recomm5dation = ! appropriate           
classification ( ! accessory bas$ on !  
int5d$ use or uses ( ! accessory4 ,su*  
submission may include appropriate      

in=mation to support ! recomm5dation z  
may be specifi$ by ! ,secret>y4  7ii7 ,!
 ,secret>y %all respond to a submission 
made "u clause 7i7 n lat] ?an #fj days  
aft] receiv+ su* submission by approv+  
or d5y+ ! recomm5d$ classification ( !  
accessory4 ,! ,secret>y %all provide an 
opportunity = a manufactur] to meet )   
appropriate p]sonnel ( ! ,food & ,drug  
,adm9i/ration to discuss ! appropriate  
classification ( su* accessory prior to 
mak+ a writt5 submission4  7,f7 ,no?+ 9 
?is p>agraph may be con/ru$ z preclud+ a
 manufactur] ( an accessory f us+ !     
classification process describ$ 9       
section subsection 7f77#b7 to obta9     
classification ( su* accessory4  4  #c4 
,effective date ,! am5dm5t made by      
section #b %all take effect on ! date t 
is #fj days aft] ! date ( ! enactm5t (  
?is ,act4