,i  #aad? ,,congress  #a/ ,session  ,h4 
,r4 #bdbd  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,may #ai1 #bjae ,mr4  
,%imkus introduc$ ! foll[+ bill2 :i* 0  
ref]r$ to ! ,committee on ,en]gy &      
,comm]ce  ,a ,,bill  ,to am5d ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act ) respect
 to tra9+ & ov]sight 9 lea/ burd5some   
appropriate means concept4  #a4 ,tra9+ &
 ov]sight 9 lea/ burd5some appropriate  
means concept  7a7 ,9 g5]al ,section    
#eac ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;c7 is
 am5d$ by ins]t+ aft] subsection 7i7 !  
foll[+3  7j7 ,tra9+ & ov]sight 9 lea/   
burd5some appropriate means concept     
7#a7 ,tra9+ ,ea* employee ( ! ,food &   
,drug ,adm9i/ration :o is involv$ 9 !   
review ( prem>ket submissions "u section
 #eae or section #eaj7k71 includ+       
sup]visors1 %all receive tra9+ reg>d+ ! 
mean+ & implem5tation ( ! lea/ burd5some
 appropriate means concept 9 ! context (
 ! use ( t t]m 9 subsections            
7a77#c77;,d7 & 7i77#a77;,d7 ( ?is       

section & 9 section #eae7;c77#e74  7#b7 
,guidance docum5ts  7,a7 ,draft updat$  
guidance ,n lat] ?an #ab mon?s aft] !   
date ( enactm5t ( ! #ba/ ,c5tury ,cures 
,act1 ! ,secret>y %all issue a draft    
guidance docum5t updat+ ! ,octob] #d1   
#bjjb1 guidance docum5t entitl$ ,! ,lea/
 ,burd5some ,provision ( ! ,,fda        
,mod]nization ,act ( #aiig3 ,concept &  
,pr9ciples2 ,f9al ,guidance = ,,fda &   
,indu/ry4  7,b7 ,meet+ ( /akehold]s ,9  
develop+ su* draft guidance docum5t1 !  
,secret>y %all conv5e a meet+ (         
/akehold]s to ensure a full record to   
support ! publication ( su* docum5t4    
7#c7 ,ombudsman audit ,n lat] ?an #ah   
mon?s aft] ! date ( issuance ( f9al     
v]sion ( ! draft guidance "u p>agraph   
7#b71 ! ombudsman = ! organizational    
unit ( ! ,food & ,drug ,adm9i/ration    
responsible = ! prem>ket review (       
devices %all--  7,a7 conduct1 or h      
conduct$1 an audit ( ! tra9+ describ$ 9 
p>agraph 7#a72 &  7,b7 include 9 su*    
audit int]views ) a repres5tative sample

 ( p]sons f indu/ry reg>d+ _! exp]i5ce 9
 ! device prem>ket review process4  4   
7b7 ,additional in=mation reg>d+        
prem>ket applications ,subsection 7c7 ( 
section #eae ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e7 is
 am5d$ by add+ at ! end ! foll[s3  7#e7 
7,a7 ,:5ev] ! ,secret>y reque/s         
additional in=mation f an applicant     
reg>d+ an application "u p>agraph 7#a71 
! ,secret>y %all consid] ! lea/         
burd5some appropriate means necess>y to 
demon/rate device safety & effectiv5ess1
 & reque/ in=mation accord+ly4  7,b7 ,= 
purposes ( subp>agraph 7,a71 ! 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  4