,,ii  #aae? ,,congress  #a/ ,session    
,s4 #ajgj  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,may #h1 #bjag ,mr4    
,rob]ts 7= himself1 ,mr4 ,donnelly1 &   
,mr4 ,burr7 introduc$ ! foll[+ bill2 :i*
 0 read twice & ref]r$ to ! ,committee  
on ,heal?1 ,education1 ,labor1 &        
,p5sions  ,a ,,bill  ,to am5d ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act to       
provide = ! appropriate1 risk-bas$      
classification ( device accessories bas$
 on int5d$ use4  #a4 ,%ort title  ,?is  
,act may be cit$ z ! ,realiz+ ,int5d$   
,safety = ,c]ta9 ,accessories ,act (    
#bjag4  #b4 ,risk-bas$ classification ( 
accessories ,section #eac7;b77#i7 ( !   
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cfj;c7b77#i77 is am5d$--
 7#a7 by /rik+ 7#i7 ,! ,secret>y &      
ins]t+ 7#i77;,a7 ,! ,secret>y2 &  7#b7  
by add+ at ! end ! foll[+3  7,b7 ,!     
classification ( any accessory classifi$
 prior to ,decemb] #ac1 #bjaf1 bas$ on !
 int5d$ use or uses ( su* accessory1    
%all cont9ue to apply1 not)/&+ !        

classification ( any o!r device ) :i*   
su* accessory is int5d$ to be us$4  7,c7
 7i7 ,if-- 7,i7 an accessory has be5    
cle>$ or approv$ bas$ on !              
classification ( ano!r device ) :i* su* 
accessory is int5d$ to be us$2 &  7,,ii7
 ! ,secret>y has e/abli%$ a             
classification = su* accessory bas$ on !
 int5d$ use or uses ( ! accessory1 9    
accordance ) subp>agraph 7,a71  !       
manufactur] ( su* accessory may id5tify 
! classification describ$ 9 subclause   
7,,ii7 9 a writt5 notification to !     
,secret>y4  7ii7 ,unless ! ,secret>y    
notifies a manufactur] )9 #cj cal5d>    
days ( receipt ( a writt5 notification  
describ$ 9 clause 7i7 t ! ,secret>y does
 n agree t ! classification id5tifi$ 9  
su* writt5 notification is appropriate =
 ! accessory1 ! accessory %all be       
automatically reclassifi$ 9 accordance )
 ! classification id5tifi$ 9 su* writt5 
notification4  7iii7 ,a writt5          
notification t ! ,secret>y disagrees ) !
 classification id5tifi$ 9 a writt5     

notification describ$ 9 clause 7ii7 %all
 include a detail$ description &        
ju/ification = ! det]m9ation to         
disagree4  7,d7 7i7 ,a manufactur] ( an 
accessory t has be5 previ\sly classifi$ 
by ! ,secret>y bas$ on ! int5d$ use (   
ano!r device ) :i* ! accessory is int5d$
 to be us$1 ?r\gh an application = su*  
o!r device "u section #eae7;c71 a report
 "u section #eaj7k71 or a petition =    
classification "u section #eac7;f77#b71 
& t has n be5 classifi$ by ! ,secret>y  
bas$ on ! int5d$ use or uses ( !        
accessory z describ$ 9 subp>agraph 7,a7 
or 7,c71 may submit to ! ,secret>y a    
writt5 recomm5dation = ! appropriate    
classification ( su* accessory bas$ on  
its int5d$ use or uses4 ,su* submission 
%all include su* in=mation to support ! 
recomm5dation z ! ,secret>y may require4
  7ii7 ,! ,secret>y %all respond to a   
submission "u clause 7i7 )9 #fj cal5d>  
days by approv+ or d5y+ ! recomm5d$     
classification ( ! accessory4 ,if !     
,secret>y does n agree ) ! recomm5dation

 = classification submitt$ by ! sponsor1
 ! response %all include a detail$      
description & ju/ification = su*        
det]m9ation to disagree4 ,! ,secret>y   
%all provide an opportunity = a         
manufactur] to meet ) appropriate       
p]sonnel to discuss appropriate         
classification ( su* accessory prior to 
submitt+ a writt5 recomm5dation4  7,e7  
,at ! "t a sponsor submits an           
application = prem>ket approval = a     
class ,,iii device pursuant to section  
#eae7;c71 ! sponsor ( su* application   
may include a recomm5dation & support+  
in=mation = ! prop] classification ( su*
 accessory pursuant to subp>agraph 7,a74
 ,if su* device is int5d$ to be us$ ) an
 accessory t has n be5 classifi$ by !   
,secret>y bas$ on its int5d$ use or uses
 z describ$ 9 subp>agraph 7,a7 or 7,c71 
! ,secret>y %all--  7i7 approve or d5y !
 application pursuant to section        
#eae7;d72 &  7ii7 approve or d5y !      
classification ( ! accessory propos$ 9 !
 application submitt$ "u ?is clause4    

7,f7 ,a manufactur] may at any "t use ! 
classification process describ$ 9       
section #eac7;f77#b7 to obta9           
classification ( an accessory4  4