,i  #aag? ,,congress  #b;d ,session  ,h4
 ,r4 #hbii  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,july #g1 #bjbb,mr4   
,bilirakis 7= himself & ,mr4            
,o',hall]an7 introduc$ ! foll[+ bill2   
:i* 0 ref]r$ to ! ,committee on ,en]gy &
 ,comm]ce  ,a ,,bill  ,to all[ = devices
 ) a pr$et]m9$ *ange control plan to be 
m>ket$ )\t submitt+ a supplem5tal       
application or prem>ket notification if 
! *anges to su* devices are consi/5t )  
su* plan4  #a4 ,pr$et]m9$ *ange control 
plans = devices  7a7 ,9 g5]al ,*apt] ,v 
( ! ,f$]al ,food1 ,drug1 & ,cosmetic    
,act 7#ba ,u4,s4,c4 #cea et seq47 is    
am5d$ by ins]t+ aft] section #eae;,b    
7#ba ,u4,s4,c4 #cfj;e-#c7 ! foll[+3     
#eae;,c4 ,pr$et]m9$ *ange control plans 
= devices  7a7 ,approv$ devices  7#a7 ,9
 g5]al ,not)/&+ section                 
#eae7;d77#e77;,a71 a supplem5tal        
application %all n be requir$ = a *ange 
to a device approv$ "u section #eae1 if 
su* *ange is consi/5t ) a pr$et]m9$     
*ange control plan t is approv$ pursuant

 to p>agraph 7#b74  7#b7 ,pr$et]m9$     
*ange control plan ,! ,secret>y may     
approve a pr$et]m9$ *ange control plan  
submitt$ 9 an application1 includ+ a    
supplem5tal application1 "u section #eae
 t describes plann$ *anges t may be made
 to ! device 7& t w\ld o!rwise require a
 supplem5tal application "u section     
#eae71 if ! device rema9s safe &        
effective )\t any *ange4  7#c7 ,scope ,!
 ,secret>y may require t a *ange control
 plan include label+ requir$ = safe &   
effective use ( ! device z su* device   
*anges pursuant to su* plan1            
notification requirem5ts if ! device    
does n function z int5d$ pursuant to su*
 plan1 & p]=mance requirem5ts = *anges  
made "u ! plan4  7b7 ,cle>$ devices     
7#a7 ,9 g5]al ,not)/&+ section #eaj7k71 
a prem>ket notification %all n be       
requir$ = a *ange to a device cle>$ "u  
section #eaj7k71 if su* *ange is        
consi/5t ) an e/abli%$ pr$et]m9$ *ange  
control plan grant$ pursuant to p>agraph
 7#b74  7#b7 ,pr$et]m9$ *ange control   

plan ,! ,secret>y may cle> a pr$et]m9$  
*ange control plan submitt$ 9 a         
notification submitt$ "u section #eaj7k7
 t describes plann$ *anges t may be made
 to ! device 7& t w\ld o!rwise require a
 new notification71 if--  7,a7 ! device 
rema9s safe & effective )\t any su*     
*ange2 &  7,b7 ! device w\ld rema9      
sub/antially equival5t to ! pr$icate4   
7#c7 ,scope ,! ,secret>y may require t a
 *ange control plan include label+      
requir$ = safe & effective use ( !      
device z su* device *anges pursuant to  
su* plan1 notification requirem5ts if ! 
device does n function z int5d$ pursuant
 to su* plan1 & p]=mance requirem5ts =  
*anges made "u ! plan4  7c7 ,pr$icate   
devices ,9 mak+ a det]m9ation (         
sub/antial equival5ce pursuant to       
section #eac7;i71 ! ,secret>y %all n    
comp>e a device to *ang$ v]sions ( a    
device implem5t$ 9 accordance ) an      
e/abli%$ pr$et]m9$ *ange control plan z 
a pr$icate device4 ,only ! v]sion ( !   
device cle>$ or approv$1 prior to *anges

 made "u ! pr$et]m9$ *ange control plan1
 may be us$ by a sponsor z a pr$icate   
device4  4  7b7 ,con=m+ am5dm5ts  7#a7  
,cle>$ devices ,section #eaj7l77#a7 ( ! 
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cfj7l77#a77 is am5d$1 9 
! fir/ s5t5ce1 by ins]t+ 1 or ) respect 
to a *ange t is consi/5t ) a pr$et]m9$  
*ange control plan cle>$ "u section     
#eae;,c be=e ! p]iod at ! end4  7#b7    
,approv$ devices ,section               
#eae7;d77#e77;,a77i7 ( ! ,f$]al ,food1  
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cfj;e7d77#e77;,a77i77 is am5d$ by /rik+
 ,a supplem5tal & ins]t+ ,unless ! *ange
 is consi/5t ) a pr$et]m9$ *ange control
 plan approv$ "u section #eae;,c1 a     
supplem5tal4  7#c7 ,docum5tation (      
rationale = significant decisions       
,section #eag;,a7a77#a7 ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfj;g-#a7;a77#a77 is am5d$ to
 read z foll[s3  7#a7 ,9 g5]al ,!       
,secret>y %all provide a sub/antive     
summ>y ( ! sci5tific & regulatory       

rationale = any significant decision ( !
 ,c5t] = ,devices & ,radiological ,heal?
 reg>d+ submission or review ( a report 
"u section #eaj7k71 a petition =        
classification "u section #eac7;f71 an  
application "u section #eae1 or an      
application = an exemption "u section   
#ebj7;g71 includ+ docum5tation (        
significant controv]sies or diff]5ces ( 
op9ion & ! resolution ( su* controv]sies
 or diff]5ces ( op9ion4  4