,i  #aae? ,,congress  #a/ ,session  ,h4 
,r4 #bjji  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,april #f1 #bjag,mr4  
,co/ello ( ,p5nsylvania 7= himself &    
,mr4 ,pet]s7 introduc$ ! foll[+ bill2   
:i* 0 ref]r$ to ! ,committee on ,en]gy &
 ,comm]ce  ,a ,,bill  ,to am5d ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act to       
provide cl>ity ) respect to ! regulation
 ( diagno/ic imag+ devices int5d$ = use 
) contra/ ag5ts4  #a4 ,%ort title ,?is  
,act may be cit$ z ! ,fo/]+ ,innovation 
9 ,m$ical ,imag+ ,act ( #bjag4  #b4     
,approval ( applications = c]ta9        
diagno/ic m$ical imag+ devices ,section 
#ebj ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act 7#db ,u4,s4,c4 #cfj;j7 is
 am5d$ by add+ at ! end ! foll[+3  7p7  
,diagno/ic imag+ devices int5d$ = use ) 
contra/ ag5ts  7#a7 ,! ,secret>y may1   
subject to ! succe$+ provisions ( ?is   
subsection1 approve an application 7or  
supplem5t to su* an application7        
submitt$ "u section #eae ) respect to an
 applicable m$ical imag+ device1 or1 9 !

 case ( an applicable m$ical imag+      
device = :i* a notification 0 submitt$  
"u section #eaj7k7 7or a supplem5t to   
su* a notification71 may make a         
sub/antial equival5ce det]m9ation )     
respect to su* applicable m$ical imag+  
device1 if ! indications & conditions ( 
use propos$ 9 su* application or        
notification d n involve ! use ( a      
contra/ ag5t--  7,a7 9 a conc5tration1  
rate ( adm9i/ration1 or r\te (          
adm9i/ration t is diff]5t f ^? describ$ 
9 ! approv$ label+ ( ! contra/ ag5t2    
7,b7 9 a region1 organ1 or sy/em ( !    
body t is diff]5t f ^? describ$ 9 !     
approv$ label+ ( ! contra/ ag5t1 unless 
! ,secret>y det]m9es1 bas$ on in=mation 
conta9$ 9 ! application or notification 
involv$1 t ! diff]5ce does n r$uce !    
safety ( ! contra/ ag5t :5 us$ ) !      
device2  7,c7 9 a new pati5t population 
= :i* ! contra/ ag5t is det]m9$ by !    
,secret>y to pose an increas$ risk2 or  
7,d7 9 an imag+ modality 7su* z an      
ultrasonic1 ioniz+ radiation1 or        

magnetic resonance imag9e modality7 t is
 diff]5t f ^? describ$ 9 ! approv$      
label+ ( ! contra/ ag5t4  7#b7 ,! ag5cy 
c5t] *>g$ ) prem>ket review ( devices   
%all h prim>y jurisdiction ) respect to 
! review ( an application or            
notification describ$ 9 p>agraph 7#a74  
,9 conduct+ su* review1 su* ag5cy c5t]  
may--  7,a7 consult ) ! ag5cy c5t] *>g$ 
) ! prem>ket review ( drugs & biological
 products2 &  7,b7 review in=mation &   
data provid$ to ! ,secret>y by ! sponsor
 ( a contra/ ag5t 9 an application      
submitt$ "u section #eje1 s long z !    
sponsor ( su* contra/ ag5t has provid$  
to ! sponsor ( ! applicable m$ical imag+
 device t is ! subject ( su* review a "r
 ( ref]5ce or use4  7#c7 ,an application
 submitt$ "u section #eae or a          
notification submitt$ "u section #eaj7k7
 ) respect to an applicable m$ical imag+
 device %all be subject to ! requirem5ts
 ( su* respective section1 & %all n be  
subject to subsection 7d7 or 7e7 (      
section #eje 7includ+ ! sub/antial      

evid5ce /&>d specifi$ 9 su*             
subsections74  7#d7 ,an application     
submitt$ "u section #eae or a           
notification submitt$ "u section #eaj7k7
 ) respect to an applicable m$ical imag+
 device int5d$ = use 9 conjunction ) a  
contra/ ag5t to :i* clause 7ii7 or 7iii7
 ( section #eje7;c77#c77;,e7 applies    
%all ref] to su* contra/ ag5t by trade  
or br& "n1 r ?an to a class ( drugs4    
7#e7 ,= purposes ( ?is subsection &     
section #eje7y7-- 7,a7 ! t]m applicable 
m$ical imag+ device means a device      
int5d$ to be us$ 9 conjunction ) a      
contra/ ag5t 7or class ( contra/ ag5ts7 
= a use t is n describ$ 9 ! indications 
& usage section ( ! approv$ label+ ( su*
 contra/ ag5t 7or ! approv$ label+ ( any
 contra/ ag5t 9 ! same class z su*      
contra/ ag5t72 &  7,b7 ! t]m contra/    
ag5t means a drug t-- 7i7 is a          
radioactive drug 7z def9$ 9 section     
#caj4c7n7 ( title #ba1 ,code ( ,f$]al   
,regulations72 or  7ii7  7,i7 is approv$
 "u section #eje2  7,,ii7 is int5d$ =   

use 9 conjunction ) a diagno/ic imag+   
device2 &  7,,iii7 a*ieves its int5d$   
use by enhanc+ ! contra/ betwe5 a t>get 
tissue1 /ructure1 or fluid & ! surr\nd+ 
tissues or /ructures )9 ! body4  4  #c4 
,applications = approval ( contra/ ag5ts
 int5d$ = use ) c]ta9 diagno/ic m$ical  
imag+ devices ,section #eje ( ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act 7#db     
,u4,s4,c4 #cee7 is am5d$ by add+ at !   
end ! foll[+3  7y7 ,contra/ ag5ts int5d$
 = use ) applicable m$ical imag+ devices
  7#a7 ,! sponsor ( a contra/ ag5t = :i*
 an application has be5 approv$ "u ?is  
section may submit a supplem5t to !     
application seek+ approval = ! use ( !  
contra/ ag5t = a new contra/ indication4
  7#b7 ,9 review+ a supplem5t submitt$  
"u ?is subsection1 ! ag5cy c5t] *>g$ ) !
 prem>ket review ( drugs may--  7,a7    
consult ) ! c5t] *>g$ ) ! prem>ket      
review ( devices2 &  7,b7 review        
in=mation & data submitt$ to ! ,secret>y
 by ! sponsor ( an applicable m$ical    
imag+ device pursuant to section #eae or

 #eaj7k71 s long z ! sponsor ( su*      
applicable m$ical imag+ device has      
provid$ to ! sponsor ( ! contra/ ag5t a 
"r ( ref]5ce or use4  7#c7 ,= purposes (
 ?is subsection-- 7,a7 ! t]m new contra/
 indication means a use ( a contra/ ag5t
 t is describ$ 9 ! approv$ label+ ( an  
applicable m$ical imag+ device describ$ 
9 section #ebj7p71 b t is n describ$ 9 !
 indications & usage section ( ! approv$
 label+ ( ! contra/ ag5t2 &  7,b7 ! t]m 
applicable m$ical imag+ device & contra/
 ag5t h ! mean+s giv5 su* t]ms 9 section
 #ebj7p74  4