,i  #aac? ,,congress  #a/ ,session  ,h4 
,r4 #ccjc  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,octob] #bb1          
#bjac,mrs4 ,blackburn 7= h]self1 ,mr4   
,g5e ,gre5 ( ,texas1 ,mr4 ,wald51 ,ms4  
,de,gette1 ,mr4 ,butt]field1 & ,mr4     
,g+rey ( ,georgia7 introduc$ ! foll[+   
bill2 :i* 0 ref]r$ to ! ,committee on   
,en]gy & ,comm]ce  ,a ,,bill  ,to am5d !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
to provide = regulat+ m$ical s(tw>e1 & =
 o!r purposes4  #a4 ,%ort title ,?is    
,act may be cit$ z ! ,s5sible ,ov]sight 
= ,te*nology :i* ,advances ,regulatory  
,effici5cy ,act ( #bjac or ! ,,s(tw>e   
,act ( #bjac4  #b4 ,m$ical s(tw>e  7a7  
,def9ition ( m$ical s(tw>e ,section #bja
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4 #cba7 is am5d$ by   
add+ at ! end ! foll[+3  7ss7 ,! t]m    
m$ical s(tw>e means s(tw>e t is int5d$ =
 human or animal use &-- 7#a7 7,a7 is   
int5d$ to be m>ket$ to directly *ange ! 
/ructure or any function ( ! body ( man 
or o!r animals2 or  7,b7 is int5d$ to be

 m>ket$ = use by consum]s & makes       
recomm5dations = cl9ical action t-- 7i7 
includes ! use ( a drug1 device1 or     
proc$ure to cure or treat a disease or  
o!r condition )\t requir+ ! involvem5t (
 a heal? c>e provid]2 &  7ii7 if foll[$1
 w\ld *ange ! /ructure or any function (
 ! body ( man or o!r animals2  7#b7 is n
 s(tw>e ^: prim>y purpose is integral to
 ! function+ ( a drug or device2 &  7#c7
 is n a compon5t ( a device4  4  7b7    
,regulation ,sub*apt] ,a ( *apt] ,v ( ! 
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cea et seq47 is am5d$ by
 add+ at ! end ! foll[+3  #ebd;,b4      
,m$ical s(tw>e  7a7 ,9 g5]al ,!         
provisions ( ?is ,act %all apply )      
respect to m$ical s(tw>e to ! same ext5t
 & 9 ! same mann] z su* provisions apply
 ) respect to devices4  7b7 ,delegation 
,! ,secret>y %all delegate prim>y       
jurisdiction = regulat+ m$ical s(tw>e to
 ! c5t] at ! ,food & ,drug ,adm9i/ration
 *>g$ ) regulat+ devices4  4  #c4       
,cl9ical s(tw>e & heal? s(tw>e  7a7     

,def9itions ,section #bja ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cba71 z am5d$ by section     
#b7;a71 is fur!r am5d$ by add+ at ! end 
! foll[+3  7tt7 7#a7 ,! t]m cl9ical     
s(tw>e means cl9ical decision support   
s(tw>e or o!r s(tw>e 7includ+ any       
associat$ h>dw>e & process dep5d5cies7  
int5d$ = human or animal use t-- 7,a7   
captures1 analyzes1 *anges1 or pres5ts  
pati5t or population cl9ical data or    
in=mation & may recomm5d c\rses (       
cl9ical action1 b does n directly *ange 
! /ructure or any function ( ! body (   
man or o!r animals2 &  7,b7 is int5d$ to
 be m>ket$ = use only by a heal? c>e    
provid] 9 a heal? c>e sett+4  7#b7 ,!   
t]m heal? s(tw>e means s(tw>e 7includ+  
any associat$ h>dw>e & process          
dep5d5cies7 t is n m$ical s(tw>e or     
cl9ical s(tw>e &-- 7,a7 t captures1     
analyzes1 *anges1 or pres5ts pati5t or  
population cl9ical data or in=mation2   
7,b7 t supports adm9i/rative or         
op]ational aspects ( heal? c>e & is n   

us$ 9 ! direct deliv]y ( pati5t c>e2 or 
7,c7 ^: prim>y purpose is to act z a    
plat=m = a second>y s(tw>e1 to run or   
act z a me*anism = connectivity1 or to  
/ore data4  4  7b7 ,prohibition         
,sub*apt] ,a ( *apt] ,v ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cea et seq471 z am5d$ by     
section #b7;b71 is fur!r am5d$ by add+  
at ! end ! foll[+3  #ebd;,c4 ,cl9ical   
s(tw>e & heal? s(tw>e ,cl9ical s(tw>e & 
heal? s(tw>e %all n be subject to       
regulation "u ?is ,act4  4  7c7 ,s5se ( 
,congress ,x is ! s5se ( ! ,congress t--
 7#a7 cl9ical s(tw>e & heal? s(tw>e 7z  
def9$ 9 section #bja7tt7 ( ! ,f$]al     
,food1 ,drug1 & ,cosmetic ,act1 z add$  
by subsection 7a77-- 7,a7 advance !     
goals ( enhanc$ pati5t safety & cont9u$ 
innovation2  7,b7 hold mu* promise to   
l[] co/s & improve ! heal? ( pati5ts2 & 
7,c7 c improve ! quality & efficacy (   
heal? c>e provid] s]vices2 &  7#b7 !    
,presid5t & ! ,congress %\ld "w toge!r  
to develop & enact legislation t        

e/abli%es a risk-bas$ regulatory        
framework = su* cl9ical s(tw>e & heal?  
s(tw>e t r$uces regulatory burd5s1      
promotes pati5t safety1 & fo/]s         
innovation4  #d4 ,exclusion f def9ition 
( device ,section #bja7;h7 ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cba7 is am5d$-- 7#a7 9       
p>agraph 7#b71 by /rik+ or o!r animals1 
or & ins]t+ or o!r animals12  7#b7 9    
p>agraph 7#c71 by /rik+ &2 &  7#c7 by   
ins]t+ aft] p>agraph 7#c7 ! foll[+ new  
p>agraphs3  7#d7 is n m$ical s(tw>e1 or 
7#e7 is n cl9ical s(tw>e or heal?       
s(tw>e1 &  4