,i  #aae? ,,congress  #a/ ,session  ,h4 
,r4 #bdhc  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,may #ag1 #bjag,mr4   
,hudson 7= himself & ,mr4 ,buc%on7      
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,en]gy & ,comm]ce  ,a  
,,bill  ,to am5d ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act to provide = !         
e/abli%m5t ( a ?ird-p>ty quality sy/em  
assessm5t program = devices1 & = o!r    
purposes4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,quality ,sy/ems           
,c]tification ,act ( #bjag4  #b4        
,?ird-p>ty quality sy/em assessm5t  7a7 
,e/abli%m5t ( ?ird-,p>ty quality sy/em  
assessm5t program ,*apt] ,v ( ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act is am5d$ 
by ins]t+ aft] section #ebd;,a 7#ba     
,u4,s4,c4 #cfjn-#a7 ! foll[+ new        
section3  #ebd;,b4 ,?ird-p>ty quality   
sy/em assessm5t  7a7 ,accr$itation &    
assessm5t  7#a7 ,9 g5]al2 c]tification (
 device quality sy/em ,! ,secret>y %all1
 9 accordance ) ?is section1 e/abli% a  
?ird-p>ty quality sy/em assessm5t       

program--  7,a7 to accr$it p]sons to    
assess :e!r a reque/or's quality sy/em1 
includ+ its design controls1 c          
reasonably assure ! safety &            
effectiv5ess ( 9-scope devices subject  
to device-relat$ *anges2  7,b7 "u :i*   
accr$it$ p]sons %all 7z applicable7     
c]tify t a reque/or's quality sy/em     
meets ! crit]ia includ$ 9 ! guidance    
issu$ "u p>agraph 7#e7 ) respect to !   
9-scope devices at issue2 &  7,c7 "u :i*
 ! ,secret>y %all rely on su*           
c]tifications = purposes ( det]m9+ !    
safety & effectiv5ess 7or z applicable1 
sub/antial equival5ce7 ( 9-scope devices
 subject to ! device-relat$ *anges      
involv$1 9 lieu ( compliance ) ! foll[+ 
submission requirem5ts3  7i7 ,a prem>ket
 notification4  7ii7 ,a #cj-;day notice4
  7iii7 ,a ,special ,,pma supplem5t4    
7#b7 ,def9itions ,= purposes ( ?is      
section  7,a7 ! t]m device-relat$ *anges
 means *anges made by a reque/or )      
respect to 9-scope devices1 :i* are--   
7i7 *anges to a device f\nd to be       

sub/antially equival5t "u sections      
#eac7;i7 & #eaj7k7 to a pr$icate device1
 t--  7,i7 w\ld o!rwise be subject to a 
prem>ket notification2 &  7,,ii7 d n    
alt]--  7aa7 ! int5d$ use ( ! *ang$     
device2 or  7bb7 ! fundam5tal sci5tific 
te*nology ( su* device2  7ii7           
manufactur+ *anges subject to a #cj-;day
 notice2  7iii7 *anges t qualify = a    
,special ,,pma ,supplem5t2 &  7iv7 su*  
o!r *anges relat+ to ! devices or !     
device manufactur+ process z ! ,secret>y
 det]m9es appropriate2  7,b7 ! t]m      
9-scope device means a device )9 ! scope
 ( devices agre$ to by ! reque/or & !   
accr$it$ p]son = purposes ( a reque/ =  
c]tification "u ?is section2  7,c7 ! t]m
 prem>ket notification means a prem>ket 
notification "u section #eaj7k72  7,d7 !
 t]m quality sy/em means ! me?ods us$ 91
 & ! facilities & controls us$ =1 !     
design1 manufacture1 packag+1 label+1   
/orage1 in/allation1 & s]vic+ ( devices1
 z describ$ 9 section #ebj7;f72  7,e7 ! 
t]m reque/or means a device manufactur] 

t is seek+ c]tification "u ?is section (
 a quality sy/em us$ by su* manufactur]2
  7,f7 ! t]m ,special ,,pma means a     
,special ,,pma supplem5t "u section     
#had4ci7;d7 ( title #ba1 ,code ( ,f$]al 
,regulations 7or any successor          
regulations72 &  7,g7 ! t]m #cj-;day    
notice means a notice describ$ 9 section
 #eae7;d77#e74  7#c7 ,accr$itation      
process2 accr$itation r5ewal ,except z  
inconsi/5t ) ?is section1 ! process &   
qualifications = accr$itation ( p]sons &
 r5ewal ( su* accr$itation "u section   
#gjd7;g7 %all apply ) respect to        
accr$itation ( p]sons & r5ewal ( su*    
accr$itation "u ?is section4  7#d7 ,use 
( accr$it$ p>ties to conduct assessm5ts 
7,a7 ,initiation ( assessm5t s]vices    
7i7 ,date assessm5ts au?oriz$ ,beg9n+   
aft] ! date on :i* ! f9al guidance is   
issu$ "u p>agraph 7#e71 an accr$it$     
p]son may conduct an assessm5t "u ?is   
section4  7ii7 ,initiation ( assessm5ts 
,use ( "o or m accr$it$ p]sons to assess
 a reque/or's quality sy/em "u ?is      

section ) respect to 9-scope devices    
%all be at ! initiation ( ! p]son :o    
regi/]s & li/s ! devices at issue "u    
section #eaj4  7,b7 ,comp5sation        
,comp5sation = su* accr$it$ p]sons      
%all-- 7i7 be det]m9$ by agreem5t betwe5
 ! accr$it$ p]son & ! p]son :o engages !
 s]vices ( ! accr$it$ p]son2 &  7ii7 be 
paid by ! p]son :o engages su* s]vices4 
7,c7 ,accr$it$ p]son selection ,ea*     
p]son :o *ooses to use an accr$it$ p]son
 to assess a reque/or's quality sy/em1 z
 describ$ 9 ?is section1 %all select !  
accr$it$ p]son f a li/ ( su* p]sons     
publi%$ by ! ,secret>y 9 accordance )   
section #gjd7;g77#d74  7#e7 ,guidance2  
crit]ia = c]tification  7,a7 ,9 g5]al ,!
 crit]ia = c]tification ( a quality     
sy/em "u ?is section %all be z specifi$ 
by ! ,secret>y 9 guidance issu$ "u ?is  
p>agraph4  7,b7 ,cont5ts2 crit]ia ,!    
guidance "u ?is p>agraph %all include   
specification (-- 7i7 evaluative crit]ia
 to be us$ by an accr$it$ p]son to      
assess &1 z applicable1 c]tify a        

reque/or's quality sy/em "u ?is section 
) respect to 9-scope devices2 &  7ii7   
crit]ia = accr$it$ p]sons to apply = a  
waiv] (1 & exemptions f1 ! crit]ia "u   
clause 7i74  7,c7 ,timeframe = issu+    
guidance ,! ,secret>y %all issue "u ?is 
p>agraph-- 7i7 draft guidance n lat] ?an
 #ab mon?s aft] ! enactm5t ( ! #ba/     
,c5tury ,cures ,act2 &  7ii7 f9al       
guidance n lat] ?an #ab mon?s aft]      
issuance ( ! draft guidance "u clause   
7i74  7b7 ,use ( ?ird-,p>ty assessm5t   
7#a7 ,assessm5t summ>y2 c]tification    
7,a7 ,submission ( assessm5t to secret>y
 ,an accr$it$ p]son :o assesses a       
reque/or's quality sy/em "u subsection  
7a7 %all submit to ! ,secret>y a summ>y 
( ! assessm5t--  7i7 )9 #cj days ( !    
assessm5t2 &  7ii7 :i* %all include 7z  
applicable7--  7,i7 ! accr$it$ p]son's  
c]tification t ! reque/or has satisfi$ !
 crit]ia specifi$ 9 ! guidance issu$ "u 
subsection 7a77#e7 = quality sy/em      
c]tification ) respect to ! 9-scope     
devices at issue2 &  7,,ii7 any waiv]s  

or exemptions f su* crit]ia appli$ by ! 
accr$it$ p]son4  7,b7 ,treatm5t (       
assessm5ts ,subject to action by !      
,secret>y "u subp>agraph 7,c71 ) respect
 to assessm5ts :i* include a            
c]tification "u ?is section--  7i7 !    
,secret>y's review ( ! assessm5t summ>y 
%all be deem$ complete on ! day t is #cj
 days aft] ! date on :i* ! ,secret>y    
receives ! summ>y "u subp>agraph 7,a72 &
  7ii7 ! assessm5t summ>y & c]tification
 ( ! quality sy/em ( a reque/or %all be 
deem$ accept$ by ! ,secret>y on su* #cj?
 day4  7,c7 ,actions by secret>y  7i7 ,9
 g5]al ,)9 #cj days ( receiv+ an        
assessm5t summ>y & c]tification "u      
subp>agraph 7,a71 ! ,secret>y may1 by   
writt5 notice to ! accr$it$ p]son       
submitt+ su* assessm5t c]tification1    
deem any su* c]tification to be         
provisional beyond su* #cj-;day p]iod1  
susp5d$ p5d+ fur!r review by !          
,secret>y1 or o!rwise qualifi$ or       
cancell$1 bas$ on ! ,secret>y's         
det]m9ation t 7z applicable7--  7,i7    

additional in=mation is ne$$ to support 
su* c]tification2  7,,ii7 su* assessm5t 
or c]tification is unw>rant$2 or        
7,,iii7 su* action ) reg>d to !         
c]tification is o!rwise ju/ifi$ accord+ 
to su* factors & crit]ia z ! ,secret>y  
f9ds appropriate4  7ii7 ,acceptance (   
c]tification ,if foll[+ action by !     
,secret>y "u clause 7i7 ) respect to a  
c]tification1 ! ,secret>y det]m9es t su*
 c]tification is acceptable1 ! ,secret>y
 %all issue writt5 notice to !          
applicable accr$it$ p]son indicat+ su*  
acceptance4  7#b7 ,notifications to     
,secret>y by c]tifi$ reque/ors or       
accr$it$ p]sons = program evaluation    
purposes  7,a7 ,annual summ>y report =  
device-relat$ *anges o!rwise subject to 
prem>ket notification ,a reque/or ^:    
quality sy/em is c]tifi$ "u ?is section 
t effectuates device-relat$ *anges )    
respect to 9-scope devices1 )\t prior   
submission ( a prem>ket notification1   
%all ensure t an annual summ>y report is
 submitt$ to ! ,secret>y by ! accr$it$  

p]son :i*--  7i7 describes ! *anges made
 to ! 9-scope device2 &  7ii7 indicates 
! effective dates ( su* *anges4  7,b7   
,p]iodic notification = manufactur+     
*anges o!rwise subject to #cj-;day      
notice ,a reque/or ^: quality sy/em is  
c]tifi$ "u ?is section t effectuates    
device-relat$ *anges ) respect to       
9-scope devices1 )\t prior submission ( 
a #cj-;day notice1 %all provide         
notification to ! ,secret>y ( su* *anges
 9 ! reque/or's next p]iodic report "u  
section #had4hd7;b7 ( title #ba1 ,code (
 ,f$]al ,regulations 7or any successor  
regulation74 ,su* notification %all--   
7i7 describe ! *anges made2 &  7ii7     
indicate ! effective dates ( su* *anges4
  7,c7 ,p]iodic notification =          
device-relat$ *anges o!rwise subject to 
special pma supplem5t ,a reque/or ^:    
quality sy/em is c]tifi$ "u ?is section 
t effectuates device-relat$ *anges )    
respect to 9-scope devices1 )\t prior   
submission ( a ,special ,,pma           
,supplem5t1 %all provide notification to

 ! ,secret>y ( su* *anges 9 ! reque/or's
 next p]iodic report "u section         
#had4hd7;b7 ( title #ba1 ,code ( ,f$]al 
,regulations 7or any successor          
regulation74 ,su* notification %all--   
7i7 describe ! *anges made1 includ+ a   
full explanation ( ! basis = ! *anges2 &
  7ii7 indicate ! effective dates ( su* 
*anges4  7,d7 ,use ( notifications =    
program evaluation purposes ,in=mation  
submitt$ to ! ,secret>y "u subp>agraphs 
7,a7 ?r\gh 7,c7 %all be us$ by !        
,secret>y = purposes ( ! program        
evaluation "u subsection 7d74  7c7      
,duration & effect ( c]tification ,a    
c]tification "u ?is section-- 7#a7 %all 
rema9 9 effect = a p]iod ( #b ye>s f !  
date su* c]tification is accept$ by !   
,secret>y1 subject to p>agraph 7#f72    
7#b7 may be r5ew$ ?r\gh ! process       
describ$ 9 subsection 7a77#c72  7#c7    
%all cont9ue to apply ) respect to      
device-relat$ *anges made dur+ su*      
#b-ye> p]iod1 provid$ ! c]tification    
rema9s 9 effect1 irrespective ( :e!r su*

 c]tification is r5ew$ aft] su* #b-ye>  
p]iod2  7#d7 %all h no effect on ! ne$  
to comply ) applicable submission       
requirem5ts specifi$ 9 subsection       
7a77#a77;,c7 ) respect to any *ange     
p]ta9+ to 9-scope devices :i* is n a    
device-relat$ *ange "u subsection       
7a77#b72  7#e7 %all h no effect on !    
au?ority ( ! ,secret>y to conduct an    
inspection or o!rwise det]m9e :e!r !    
reque/or has compli$ ) ! applicable     
requirem5ts ( ?is ,act2 &  7#f7 may be  
revok$ by ! ,secret>y ^u a det]m9ation t
 ! reque/or's quality sy/em no long]    
meets ! crit]ia specifi$ 9 ! guidance   
issu$ "u subsection 7a77#e7 ) respect to
 ! 9-scope devices at issue4  7d7       
,notice ( revocation ,! ,secret>y %all  
provide writt5 notification to !        
reque/or ( a revocation pursuant to     
subsection 7c77#f7 n lat] ?an #aj       
bus9ess days aft] ! det]m9ation describ$
 9 su* subsection4 ,^u receipt ( !      
writt5 notification1 ! reque/or %all    
satisfy ! applicable submission         

requirem5ts specifi$ 9 subsection       
7a77#a77;,c7 = any device-relat$ *anges 
effectuat$ aft] ! date ( su*            
det]m9ation4 ,aft] su* revocation1 su*  
reque/or is eligible to seek            
re-c]tification "u ?is section ( its    
quality sy/em4  7e7 ,program evaluation2
 sunset  7#a7 ,program evaluation &     
report  7,a7 ,evaluation ,! ,secret>y   
%all complete an evaluation ( !         
?ird-p>ty quality sy/em assessm5t       
program "u ?is section no lat] ?an      
,janu>y #ca1 #bjba1 bas$ on--  7i7      
analysis ( in=mation f a repres5tative  
gr\p ( device manufactur]s obta9$ f     
notifications provid$ by c]tifi$        
reque/ors or accr$it$ p]sons "u         
subsection 7b77#b72 &  7ii7 su* o!r     
available in=mation & data z ! ,secret>y
 det]m9es appropriate4  7,b7 ,report ,no
 lat] ?an #a ye> aft] complet+ !        
evaluation "u subp>agraph 7,a71 !       
,secret>y %all issue a report ( !       
evaluation's f9d+s on ! website ( !     
,food & ,drug ,adm9i/ration1 :i* %all   

include ! ,secret>y's recomm5dations )  
respect to cont9uation & z applicable   
expansion ( ! program "u ?is section to 
encompass--  7i7 device submissions     
beyond ^? id5tifi$ 9 subsection         
7a77#a77;,c72 &  7ii7 device *anges     
beyond ^? describ$ 9 subsection         
7a77#b77;,a74  7#b7 ,sunset ,?is section
 %all cease to be effective ,octob] #a1 
#bjbb4  7f7 ,rule ( con/ruction ,no?+ 9 
?is section %all be con/ru$ to limit !  
au?ority ( ! ,secret>y to reque/ &      
review ! complete assessm5t ( a c]tifi$ 
reque/or "u ?is section on a =-cause    
basis4  4  7b7 ,con=m+ am5dm5ts  7#a7   
,requirem5ts = prem>ket approval        
supplem5ts ,section #eae7;d77#e77;,a77i7
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4                     
#cfj;e7d77#e77;,a77i77 is am5d$ by      
ins]t+ 1 subject to section #ebd;,b aft]
 t affects safety or effectiv5ess4  7#b7
 ,requirem5ts = #cj-;day notice ,section
 #eae7;d77#e77;,a77ii7 ( ! ,f$]al ,food1
 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 

#cfj;e7d77#e77;,a77ii77 is am5d$ by     
ins]t+ 1 subject to section #ebd;,b aft]
 ! date on :i* ! ,secret>y receives !   
notice4  7#c7 ,requirem5ts = prem>ket   
notification2 te*nical correction to    
ref]5ce to section #eaj7k7 ,section     
#eaj7l7 ( ! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7l77  
is am5d$ by /rik+ ( ?is subsection "u   
subsection 7m7 & ins]t+ ( subsection 7k7
 "u subsection 7m7 or section #ebd;,b4  
7#d7 ,misbr&$ devices ,section #ejb7t7 (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 7#ba ,u4,s4,c4 #ceb7t77 is am5d$ by    
ins]t+ or #ebd;,b aft] section #eai4