,,ii  #aad? ,,congress  #b;d ,session   
,s4 #bgcg  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,m>* #ag1 #bjaf ,ms4   
,klobu*> 7= h]self & ,mr4 ,rob]ts7      
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to improve m$ical device    
innovation4  #a4 ,%ort title  ,?is ,act 
may be cit$ z ! ,improv+ ,m$ical ,device
 ,innovation ,act4  #b4 ,recognition (  
/&>ds  7a7 ,9 g5]al ,section #ead7;c7 ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
7#ba ,u4,s4,c4 #cfj;d7c77 is am5d$--    
7#a7 9 p>agraph 7#a71 by ins]t+ aft]    
subp>agraph 7,b7 ! foll[+ new           
subp>agraphs3  7,c7 7i7 ,any p]son may  
submit a reque/ = recognition "u        
subp>agraph 7,a7 ( all or "p ( an       
appropriate /&>d e/abli%$ by a          
nationally or int]nationally recogniz$  
/&>d organization4  7ii7 ,n lat] ?an #fj
 cal5d> days aft] ! ,secret>y receives  
su* a reque/1 ! ,secret>y %all-- 7,i7   
make a det]m9ation to recognize all1 "p1

 or none ( ! /&>d t is ! subject ( !    
reque/2 &  7,,ii7 issue to ! p]son :o   
submitt$ su* reque/ a response 9 writ+ t
 /ates ! ,secret>y's rationale = t      
det]m9ation1 includ+ ! sci5tific1       
te*nical1 regulatory1 or o!r basis = su*
 det]m9ation4  7iii7 ,! ,secret>y %all  
take su* actions z may be necess>y to   
implem5t all or "p ( a /&>d recogniz$ "u
 subclause 7,i7 ( clause 7ii71 9        
accordance ) subp>agraph 7,a74  7,d7 ,! 
,secret>y %all make publicly available1 
9 su* mann] z ! ,secret>y det]m9es      
appropriate1 ! rationale = recognition (
 all1 "p1 or none ( a /&>d1 includ+ !   
sci5tific1 te*nical1 regulatory1 or o!r 
basis = ! decision reg>d+ su*           
recognition4  2 &  7#b7 by add+ at ! end
 ! foll[+3  7#d7 ,tra9+ on use ( /&>ds  
,! ,secret>y %all provide to all        
employees ( ! ,food & ,drug             
,adm9i/ration :o review prem>ket        
submissions = devices p]iodic tra9+ on !
 concept & use ( recogniz$ /&>ds =      
purposes ( meet+ a prem>ket submission  

requirem5t or o!r applicable requirem5t 
"u ?is ,act1 includ+ /&>ds relevant to  
an employee's area ( device review4  4  
7b7 ,guidance ,! ,secret>y ( ,heal? &   
,human ,s]vices1 act+ ?r\gh !           
,commission] ( ,food & ,drugs1 %all     
review & update1 if necess>y1 previ\sly 
publi%$ guidance & /&>d op]at+ proc$ures
 id5tify+ ! pr9ciples = recogniz+ /&>ds1
 & = )draw+ ! recognition ( /&>ds1 "u   
section #ead7;c7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cfj;d7c771 tak+ into acc\nt ! exp]i5ce 
) & reliance on a /&>d by =eign         
regulatory au?orities & ! device        
indu/ry1 & :e!r recognition ( a /&>d w  
promote h>monization among regulatory   
au?orities 9 ! regulation ( devices4    
#c4 ,c]ta9 class ,i & class ,,ii devices
  7a7 ,class i devices ,section #eaj7l7 
( ! ,f$]al ,food1 ,drug1 & ,cosmetic    
,act 7#ba ,u4,s4,c4 #cfj7l77 is am5d$-- 
7#a7 by /rik+ ,a report "u subsection   
7k7 & ins]t+ 7#a7 ,a report "u          
subsection 7k72 &  7#b7 by add+ at ! end

 ! foll[+ new p>agraph3  7#b7 ,n lat]   
?an #abj cal5d> days aft] ! date (      
enactm5t ( ! ,improv+ ,m$ical ,device   
,innovation ,act & at lea/ once e #e    
ye>s !reaft]1 z ! ,secret>y det]m9es    
appropriate1 ! ,secret>y %all id5tify1  
?r\gh publication 9 ! ,f$]al ,regi/]1   
any type ( class ,i device t ! ,secret>y
 det]m9es no long] requires a report "u 
subsection 7k7 to provide reasonable    
assurance ( safety & effectiv5ess4 ,^u  
su* publication--  7,a7 ea* type ( class
 ,i device s id5tifi$ %all be exempt f !
 requirem5t = a report "u subsection    
7k72 &  7,b7 ! classification regulation
 applicable to ea* su* type ( device    
%all be deem$ am5d$ to incorporate su*  
exemption4  4  7b7 ,class ,,ii devices  
,section #eaj7m7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cfj7m77 is am5d$-- 7#a7 by /rik+       
p>agraph 7#a7 & ins]t+ ! foll[+ new     
p>agraph3  7#a7 ,! ,secret>y %all-- 7,a7
 n lat] ?an #ij days aft] ! date (      
enactm5t ( ! ,improv+ ,m$ical ,device   

,innovation ,act & at lea/ once e #e    
ye>s !reaft]1 z ! ,secret>y det]m9es    
appropriate--  7i7 publi% 9 ! ,f$]al    
,regi/] a notice t conta9s a li/ ( ea*  
type ( class ,,ii device t ! ,secret>y  
det]m9es no long] requires a report "u  
subsection 7k7 to provide reasonable    
assurance ( safety & effectiv5ess2 &    
7ii7 provide = a p]iod ( n less ?an #fj 
cal5d> days = public comm5t beg9n+ on ! 
date ( ! publication ( su* notice2 &    
7,b7 n lat] ?an #baj cal5d> days aft] ! 
date ( enactm5t ( ! ,improv+ ,m$ical    
,device ,innovation ,act1 publi% 9 !    
,f$]al ,regi/] a li/ repres5t+ !        
,secret>y's f9al det]m9ation ) respect  
to ! devices conta9$ 9 ! li/ publi%$ "u 
subp>agraph 7,a74  2 &  7#b7 9 p>agraph 
7#b7-- 7,a7 by /rik+ #a day aft] ! date 
( publication ( a li/ "u ?is subsection1
 & ins]t+ #a cal5d> day aft] ! date (   
publication ( ! f9al li/ "u p>agraph    
7#a77;,b712 &  7,b7 by /rik+ #cj-;day   
p]iod & ins]t+ #fj-;cal5d>-day p]iod2 & 
7,c7 by add+ at ! end ! foll[+ new      

p>agraph3  7#c7 ,^u ! publication ( !   
f9al li/ "u p>agraph 7#a77;,b7-- 7,a7   
ea* type ( class ,,ii device s li/$ %all
 be exempt f ! requirem5t = a report "u 
subsection 7k72 &  7,b7 ! classification
 regulation applicable to ea* su* type (
 device %all be deem$ am5d$ to          
incorporate su* exemption4  4  #d4      
,classification panels  7a7             
,classification panels ,p>agraph 7#e7 ( 
section #eac7;b7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cfj;c7b77 is am5d$--  7#a7 by /rik+    
7#e7 & ins]t+ 7#e77;,a72 &  7#b7 by add+
 at ! end ! foll[+3  7,b7 ,:5 a device  
is specifically ! subject ( review by a 
classification panel1 ! ,secret>y %all--
 7i7 ensure t adequate exp]tise is      
repres5t$ on ! classification panel to  
assess--  7,i7 ! disease or condition   
:i* ! device is int5d$ to cure1 treat1  
mitigate1 prev5t1 or diagnose2 &  7,,ii7
 ! te*nology ( ! device2 &  7ii7 provide
 an opportunity = ! p]son ^: device is  
specifically ! subject ( panel review to

 provide recomm5dations on ! exp]tise   
ne$$ among ! vot+ memb]s ( ! panel4     
7,c7 ,= purposes ( subp>agraph 7,b77i71 
! t]m adequate exp]tise means t !       
memb]%ip ( ! classification panel       
includes-- 7i7 two or m vot+ memb]s1 ) a
 specialty or o!r exp]tise cl9ically    
relevant to ! device "u review2 &  7ii7 
at lea/ "o vot+ memb] :o is kn[l$geable 
ab\t ! te*nology ( ! device4  7,d7 ,!   
,secret>y %all provide an annual        
opportunity = pati5ts1 repres5tatives ( 
pati5ts1 & sponsors ( m$ical device     
submissions to provide recomm5dations = 
individuals ) appropriate exp]tise to   
fill vot+ memb] positions on            
classification panels4  4  7b7 ,panel   
review process ,section #eac7;b77#f7 ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cfj;c7b77#f77 is am5d$--
 7#a7 9 subp>agraph 7,a77iii71 by ins]t+
 be=e ! p]iod at ! end 1 includ+ by     
designat+ a repres5tative :o w be       
provid$ a "t dur+ ! panel meet+ to      
address ! panel individually 7or        

accompani$ by exp]ts select$ by su*     
repres5tative7 = ! purpose ( correct+   
mis/atem5ts ( fact or provid+ cl>ify+   
in=mation1 subject to ! discretion ( !  
panel *airp]son2 &  7#b7 by /rik+       
subp>agraph 7,b7 & ins]t+ ! foll[+ new  
subp>agraph3  7,b7 7i7 ,any meet+ ( a   
classification panel ) respect to !     
review ( a device %all--  7,i7 provide  
adequate "t = initial pres5tations by ! 
p]son ^: device is specifically !       
subject ( su* review & by ! ,secret>y2 &
  7,,ii7 provide adequate "t = &        
enc\rage free & op5 p>ticipation by all 
int]e/$ p]sons4  7ii7 ,foll[+ ! initial 
pres5tations describ$ 9 clause 7i71 !   
panel may--  7,i7 pose que/ions to !    
designat$ repres5tative describ$ 9      
subp>agraph 7,a77iii72 &  7,,ii7 consid]
 ! responses to su* que/ions 9 ! panel's
 review ( ! device4  4  #e4 ,po/m>ket   
pilot to improve m$ical device report+  
7a7 ,pilot projects  7#a7 ,9 g5]al ,9   
ord] to improve ! value & effici5cy (   
report+ s z to advance ! objectives (   

section #eai7;a7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cfj;i7a771 )9 "o ye> ( ! date (        
enactm5t ( ?is ,act1 ! ,secret>y (      
,heal? & ,human ,s]vices %all e/abli% "o
 or m pilot projects1 9 coord9ation )   
device manufactur]s1 to explore &       
evaluate ! use ( alt]native me?ods (    
compliance ) su* subsection =           
manufactur]s ( devices describ$ 9       
section #eac7;a77#a77;,c7 ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfj;c7a77#a77;,c774  7#b7    
,volunt>y p>ticipation ,p>ticipation 9  
su* pilot projects %all be volunt>y =   
device manufactur]s4 ,! ,secret>y may   
e/abli% ! conditions = su* volunt>y     
p>ticipation & may e/abli% a process =  
au?oriz+ p>ticipation4  7#c7 ,purposes  
,! pilot projects e/abli%$ "u p>agraph  
7#a7 %all be design$ to-- 7,a7 te/      
me?ods ( report+ = "o or m device types1
 ) priority giv5 to devices = :i* device
 manufactur]s submit a relatively high  
volume ( reports "u ! regulations       

implem5t+ section #eai7;a7 ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfj;i7a772  7,b7 evaluate =ms
 ( data monitor+ & report+ t improve !  
usability ( report data by focus+ on    
ev5ts & in=mation t are mo/ relevant to 
reasonably assur+ ! safety &            
effectiv5ess ( ! device2  7,c7 id5tify  
me?ods ( report+ t w be lea/ burd5some =
 device manufactur]s2 &  7,d7 evaluate  
me?ods t are alt]native to1 & d n       
duplicate1 compliance ) requirem5ts ( "p
 #hjc ( title #ba1 ,code ( ,f$]al       
,regulations 7or successor regulations74
  7#d7 ,notification to congress ,!     
,secret>y ( ,heal? & ,human ,s]vices    
%all notify ! ,committee on ,heal?1     
,education1 ,labor1 & ,p5sions ( !      
,s5ate & ! ,committee on ,en]gy &       
,comm]ce ( ! ,h\se ( ,repres5tatives n  
lat] ?an #ah mon?s aft] ! date (        
enactm5t ( ?is ,act ( ! numb] (         
manufactur]s t h agre$ to p>ticipate 9 a
 pilot project "u ?is subsection ) !    
,secret>y ( ,heal? & ,human ,s]vices4   

7#e7 ,rule ( con/ruction ,no?+ 9 ?is    
subsection %all limit ! au?ority ( !    
,secret>y ( ,heal? & ,human ,s]vices to 
provide = alt]native me?ods ( m$ical    
device report+ "u "p #hjc ( title #ba1  
,code ( ,f$]al ,regulations 7or         
successor regulations71 includ+ su*     
me?ods describ$ 9 ?is subsection4  7#f7 
,compliance ) requirem5ts = records or  
reports on devices  7,a7 ,9 g5]al ,a    
device manufactur] t p>ticipates 9 a    
pilot project "u ?is subsection %all be 
requir$ to comply ) all applicable      
provisions ( section #eai ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfj;i71 & implem5t+          
regulations1 except z describ$ 9        
subp>agraph 7,b74  7,b7 ,conditional    
exemption ,! ,secret>y may det]m9e t1 = 
a specifi$ "t p]iod to be det]m9$ by !  
,secret>y1 a manufactur] p>ticipat+ 9 a 
pilot project "u ?is subsection is      
exempt f c]ta9 provisions ( section     
#eai7;a7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4           

#cfj;i7a771 & implem5t+ regulations1 if 
su* manufactur] complies ) ! conditions 
set =? 9 a pilot project "u ?is         
subsection4  7b7 ,,gao review  7#a7     
,review ( pilot projects ,! ,comptroll] 
,g5]al ( ! ,unit$ ,/ates %all conduct a 
review ( ! pilot projects e/abli%$ "u   
subsection 7a71 & ( ! report+ sy/em "u  
"p #hjc ( title #ba1 ,code ( ,f$]al     
,regulations 7or successor regulations74
  7#b7 ,report ,n lat] ?an ,janu>y #ca1 
#bjba1 ! ,comptroll] ,g5]al ( ! ,unit$  
,/ates %all submit to ,congress a report
 conta9+ ! results ( ! review describ$ 9
 p>agraph 7#a74 ,su* report %all analyze
 ! value1 effici5cy1 & effectiv5ess (   
report+ me?ods "u subsections 7a7 & 7b7 
( section #eai ( ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;i7 & 
id5tify any recomm5dations = /atutory   
am5dm5ts t w\ld enhance ! objectives (  
section #eai7;a7 ( su* ,act4