,,ii  #aad? ,,congress  #a/ ,session    
,s4 #afbb  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,june #ah1 #bjae ,mr4  
,burr 7= himself & ,mr4 ,frank57        
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to am5d ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act ) respect to    
devices4  #a4 ,%ort title ,?is ,act may 
be cit$ z ! ,,fda ,device ,acc\ntability
 ,act ( #bjae4  #b4 ,ensur+ lea/        
burd5some means ( evaluat+ devices  7a7 
,tra9+ & ov]sight ( lea/ burd5some      
requirem5ts ,section #eac ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfj;c7 is am5d$ by add+ at ! 
end ! foll[+3  7j7 ,tra9+ & ov]sight (  
lea/ burd5some requirem5ts  7#a7 ,tra9+ 
& assessm5t ,! ,secret>y %all-- 7,a7    
ensure t ea* employee ( ! ,food & ,drug 
,adm9i/ration :o is involv$ 9 ! review (
 prem>ket submissions1 includ+          
sup]visors1 receives tra9+ reg>d+ !     
mean+ & implem5tation ( ! lea/ burd5some

 requirem5ts "u subsections 7a77#c77;,d7
 & 7i77#a77;,d7 & section #eae7;c77#e72 
&  7,b7 p]iodically assess !            
implem5tation ( ! lea/ burd5some        
requirem5ts1 includ+ ! employee tra9+ "u
 subp>agraph 7,a7 to ensure t ! lea/    
burd5some requirem5ts are fully &       
consi/5tly appli$4  7#b7 ,ombudsman     
audit ,n lat] ?an #ahj cal5d> days aft] 
! date ( enactm5t ( ! ,,fda ,device     
,acc\ntability ,act ( #bjae1 ! ombudsman
 = any organizational unit ( ! ,food &  
,drug ,adm9i/ration responsible = !     
prem>ket review ( devices %all--  7,a7  
conduct an audit ( ! tra9+ describ$ 9   
p>agraph 7#a77;,a72  7,b7 include 9 su* 
audit int]views ( p]sons :o are         
repres5tatives ( ! device indu/ry reg>d+
 _! exp]i5ce 9 ! device prem>ket review 
process1 includ+ ) respect to !         
application ( lea/ burd5some concepts to
 prem>ket review & ! application (      
po/m>ket requirem5ts to facilitate      
prem>ket decisionmak+2  7,c7 include 9  
su* audit an assessm5t ( ! measurem5t   

tools ! ,secret>y uses to assess !      
implem5tation ( ! lea/ burd5some        
requirem5ts1 includ+ ! effectiv5ess (   
su* tools & ! effectiv5ess ( !          
implem5tation ( ! lea/ burd5some        
requirem5ts2 &  7,d7 )9 #cj cal5d> days 
( completion ( ! audit1 make su* audit  
available-- 7i7 to ! ,committee on      
,heal?1 ,education1 ,labor1 & ,p5sions (
 ! ,s5ate & ! ,committee on ,en]gy &    
,comm]ce ( ! ,h\se ( ,repres5tatives2 & 
7ii7 on ! ,int]net website ( ! ,food &  
,drug ,adm9i/ration4  4  7b7 ,prem>ket  
applications ,section #eae7;c7 ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cfj;e7c77 is am5d$ by   
add+ at ! end ! foll[+3  7#e7 7,a7 ,9   
reque/+ additional in=mation ) respect  
to an application "u ?is section1 !     
,secret>y %all consid] ! lea/ burd5some 
appropriate means necess>y to demon/rate
 a reasonable assurance ( device safety 
& effectiv5ess4  7,b7 ,= purposes (     
subp>agraph 7,a7 ! t]m necess>y means ! 
m9imum requir$ in=mation t w\ld support 

a det]m9ation by ! ,secret>y t an       
application provides a reasonable       
assurance ( ! safety & effectiv5ess ( ! 
device4  7,c7 ,no?+ 9 ?is p>agraph alt]s
 ! /&>ds = prem>ket approval ( a device4
  7,d7 ,= purposes ( ?is p>agraph1 !    
,secret>y %all consid] :e!r ! lea/      
burd5some means ( demon/rat+ a          
reasonable assurance ( device safety &  
effectiv5ess w\ld be a*iev$ ?r\gh       
reliance on po/m>ket in=mation4  4  7c7 
,rationale = significant decisions      
reg>d+ devices ,section #eag;,a7a7 ( !  
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cfj;g-#a7;a77 is am5d$  
by add+ at ! end ! foll[+3  7#c7        
,application ( lea/ burd5some           
requirem5ts ,! sub/antive summ>y requir$
 "u ?is subsection %all include an      
explanation ( h[ ! lea/ burd5some       
requirem5ts 7 consid]$ & appli$ consi/5t
 ) section #eac7;i77#a77;,d7 & section  
#eac7;a77#c77;,d7 & section             
#eae7;c77#e71 z applicable4  4  #c4     
,p]mitt+ non-local in/itutional review  

bo>ds  7a7 ,9 g5]al ,section #ebj ( !   
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cfj7;j77 is am5d$-- 7#a7
 9 subsection 7g77#c7--  7,a7 by /rik+  
local ea* place x appe>s2 &  7,b7 9     
subp>agraph 7,a77i71 by /rik+ :i* has   
be52 &  7#b7 9 subsection 7m77#d7-- 7,a7
 by /rik+ local ea* place x appe>s2 &   
7,b7 by am5d+ subp>agraph 7,a7 to read z
 foll[s3  7,a7 9 facilities 9 :i*       
cl9ical te/+ ( devices is sup]vis$ by an
 in/itutional review committee e/abli%$ 
9 accordance ) ! regulations ( !        
,secret>y2 &  4  7b7 ,regulations ,n    
lat] ?an #a ye> aft] ! date ( ! enactm5t
 ( ?is ,act1 ! ,secret>y ( ,heal? &     
,human ,s]vices %all revise or issue su*
 regulations or guidance z may be       
necess>y to c>ry out ! am5dm5ts made by 
subsection 7a74  #d4 ,cl>ify+ ,,clia    
waiv] /udy design guidance = 9 vitro    
diagno/ics  7a7 ,draft revis$ guidance  
,n lat] ?an #a ye> aft] ! date ( !      
enactm5t ( ?is ,act1 ! ,secret>y (      
,heal? & ,human ,s]vices %all publi% a  

draft guidance t--  7#a7 revises section
 ,v4 ,demon/rat+ ,insignificant ,risk ( 
an ,errone\s ,result - ,accuracy ( !    
guidance entitl$ ,recomm5dations =      
,cl9ical ,laboratory ,improvem5t        
,am5dm5ts ( #aihh 7,,clia7 ,waiv]       
,applications = ,manufactur]s ( ,9      
,vitro ,diagno/ic ,devices & dat$       
,janu>y #cj1 #bjjh2 &  7#b7 includes    
guidance on ! appropriate use (         
comp>able p]=mance betwe5 a waiv$ us] & 
a mod]ately complex laboratory us] to   
demon/rate accuracy4  7b7 ,f9al revis$  
guidance ,! ,secret>y ( ,heal? & ,human 
,s]vices %all f9alize ! draft guidance  
publi%$ "u subsection 7a7 n lat] ?an #a 
ye> aft] ! comm5t p]iod = su* draft     
guidance closes4