,,ii  #aae? ,,congress  #a/ ,session    
,s4 #djd  ,,9 ,,! ,,s5ate ,,( ,,!       
,,unit$ ,,/ates  ,febru>y #ae1 #bjag,mr4
 ,isakson 7= himself & ,mr4 ,b5net7     
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to am5d ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act to improve !    
process = inspections ( device          
e/abli%m5ts & = grant+ export           
c]tifications4  #a4 ,f9d+s ,congress    
f9ds z foll[s3 7#a7 ,!re is a lack (    
transp>5cy & consi/5cy conc]n+          
inspections by ! ,food & ,drug          
,adm9i/ration ( m$ical device           
e/abli%m5ts ar\nd ! _w1 :i* leads to    
ineffici5cies & inconsi/5cies & und]m9es
 confid5ce 9 ,unit$ ,/ates /&>ds4  7#b7 
,inspections by ! ,food & ,drug         
,adm9i/ration ( =eign device e/abli%m5ts
 are (t5 conduct$ m effici5tly ?an      
inspections ( dome/ic device            
e/abli%m5ts4  7#c7 ,! frequ5cy & nature 
( inspections ( device e/abli%m5ts are n

 consi/5tly risk-bas$1 & a compreh5sive1
 transp>5t1 risk-bas$ approa* to        
inspections w\ld result 9 great] focus  
on ! m significant risks to public heal?
 :ile r$uc+ ! burd5s on e/abli%m5ts ) a 
/rong track record ( compliance4  7#d7  
,!re is a lack ( transp>5cy & consi/5cy 
among ,unit$ ,/ates-bas$ regional       
inspection (fices ) respect to !        
frequ5cy ( inspections ( device         
e/abli%m5ts & ! activities & conc]ns t  
trigg] =-cause inspections ( su*        
e/abli%m5ts4  7#e7 ,great] transp>5cy   
conc]n+ ! tim+ & nature ( r\t9e         
inspections ( device e/abli%m5ts w\ld   
improve ! quality & effici5cy ( !       
inspection process4  7#f7 ,enhanc+      
communications be=e1 dur+1 & aft]       
inspections 9 :i* defici5cies are       
id5tifi$1 w\ld assi/ ! ,secret>y (      
,heal? & ,human ,s]vices & ! device     
indu/ry 9 ma9ta9+ ! safety &            
effectiv5ess ( devices4  7#g7 ,guidance 
= device e/abli%m5ts is necess>y to     
provide transp>5cy & consi/5cy conc]n+  

inspection-relat$ communications4  7#h7 
,enhanc$ tra9+ opportunities = device   
e/abli%m5t inve/igators w\ld improve !  
consi/5cy & effici5cy ( ! device        
inspection process4  7#i7 ,!re is a lack
 ( transp>5cy 9 ! export c]tification   
process ) respect to device e/abli%m5ts 
= :i* ,,fda ,=m #dhc has be5 us$ to     
docum5t issues notic$ dur+ an inspection
 conduct$ pursuant to section #gjd ( !  
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cgd7 or e/abli%m5ts t h 
receiv$ ,w>n+ ,lett]s 9 connection ) su*
 an inspection1 & betwe5 dome/ic & =eign
 e/abli%m5ts1 result+ 9 devices t are   
lawfully m>ket$ = ,unit$ ,/ates pati5ts 
be+ d5i$ c]tification = m>ket+ 9 o!r    
c\ntries4  7#aj7 ,device e/abli%m5ts t h
 attempt$ to address defici5cies        
id5tifi$ by inspections c>ri$ out by !  
,food & ,drug ,adm9i/ration lack        
suffici5t opportunities to confirm t su*
 corrective actions are appropriate4    
#b4 ,risk-bas$ inspections = devices    
,p>agraph 7#b7 ( section #eaj7;h7 ( !   

,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cfj7;h77 is am5d$ to    
read z foll[s3  7#b7 ,risk-bas$ s*$ule =
 devices  7,a7 ,9 g5]al ,! ,secret>y1   
act+ ?r\gh "o or m (fic]s or employees  
duly designat$ by ! ,secret>y1 %all     
inspect e/abli%m5ts describ$ 9 p>agraph 
7#a7 t are engag$ 9 ! manufacture1      
propagation1 comp\nd+1 or process+ ( a  
device or devices 7ref]r$ to 9 ?is      
subsection z device e/abli%m5ts7 9      
accordance ) "o risk-bas$ inspection    
s*$ule e/abli%$ by ! ,secret>y1 appli$  
consi/5tly across regional (fices4  7,b7
 ,factors & consid]ations ,9 e/abli%+ ! 
risk-bas$ s*$ule "u subp>agraph 7,a71 ! 
,secret>y %all-- 7i7 apply1 to ! ext5t  
applicable = device e/abli%m5ts1 !      
factors id5tifi$ 9 p>agraph 7#d72 &     
7ii7 consid] ! p>ticipation ( ! device  
e/abli%m5t1 z applicable1 9 int]national
 device audit programs 9 :i* ! ,unit$   
,/ates p>ticipates or ! ,unit$ ,/ates   
recognizes = purposes ( inspect+4  4    
#c4 ,improvem5ts to inspections process 

= device e/abli%m5ts ,section #gjd ( !  
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cgd7 is am5d$ by add+ at
 ! end ! foll[+3  7h7 7#a7 ,! ,secret>y 
%all adopt a uni=m process & uni=m /&>ds
 applicable to inspections ( dome/ic &  
=eign device e/abli%m5ts4 ,su* process  
%all include--  7,a7 notify+ ! own]1    
op]ator1 or ag5t 9 *>ge ( ! e/abli%m5t (
 ! type & nature ( ! inspection2  7,b7  
ann\nc+ ! inspection ! e/abli%m5t )9 a  
reasonable "t be=e su* inspection2  7,c7
 9 ! case ( inspections o!r ?an =-cause 
inspections1 provid+ a reasonable       
e/imate ( ! timeframe = ! inspection1 an
 opportunity = advance communications   
betwe5 ! (fic]s or employees c>ry+ out !
 inspection "u subsection 7a77#a7 & !   
own]1 op]ator1 or ag5t 9 *>ge ( !       
e/abli%m5t conc]n+ appropriate work+    
h\rs dur+ ! inspection1 &1 to ! ext5t   
feasible1 advance notice ( records t w  
be reque/$ 9 ord] to exp$ite !          
inspection2 &  7,d7 daily communications
 ) ! own]1 op]ator1 or ag5t 9 *>ge ( !  

e/abli%m5t reg>d+ inspection /atus1 :i* 
may be record$ by ei!r p>ty ) advance   
notice4  7#b7 ,9 ! case ( device        
e/abli%m5ts t h receiv$ a report        
pursuant to subsection 7b71 & = :i* !   
own]1 op]ator1 or ag5t 9 *>ge ( su*     
e/abli%m5t submits a timely response to 
su* report t includes a reque/ = fe$back
 to ! actions propos$ 9 su* response1 ! 
,secret>y %all provide nonb9d+ fe$back  
reg>d+ su* propos$ actions )9 #de days (
 receipt ( su* reque/4  7#c7 ,no?+ 9 ?is
 subsection limits ! au?ority ( !       
,secret>y to conduct inspections o!rwise
 p]mitt$ "u ?is ,act 9 ord] to ensure   
compliance ) ?is ,act4  7#d7 7,a7 ,n    
lat] ?an #a ye> aft] ! date ( enactm5t (
 ?is subsection1 ! ,secret>y %all issue 
draft guidance t--  7i7 specifies h[ !  
,food & ,drug ,adm9i/ration w implem5t !
 process describ$ 9 p>agraph 7#a7 & !   
requirem5ts describ$ 9 p>agraph 7#b72   
7ii7 provides = /&>diz$ templates =     
communications describ$ 9 su* p>agraphs2
  7iii7 e/abli%es a /&>d timeframe ov]  

consecutive days t is applicable to bo? 
dome/ic & =eign inspections1 to :i* ea* 
inspector %all adh]e unless an          
inve/igator c id5tify to ! e/abli%m5t a 
reason t m "t is ne$$2 &  7iv7 id5tifies
 practices = inve/igators & device      
e/abli%m5ts to facilitate ! cont9uity ( 
inspections4  7,b7 ,n lat] ?an #ah mon?s
 aft] ! date ( enactm5t ( ?is           
subsection1 aft] notice & opportunity = 
public comm5t on ! draft guidance       
describ$ 9 subp>agraph 7,a71 ! ,secret>y
 %all issue f9al guidance consi/5t ) ?is
 subsection4  4  #d4 ,c]tificates to    
=eign gov]nm5ts = devices ,subsection   
7e77#d7 ( section #hja ( ! ,f$]al ,food1
 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 
#cha7;e77#d77 is am5d$--  7#a7 by add+  
at ! end ! foll[+3  7,e7 7i7 ,if !      
,secret>y d5ies a reque/ = c]tification 
) respect to a device pursuant to       
subp>agraph 7,a77ii71 ! ,secret>y %all  
provide 9 writ+ to ! p]son seek+ su*    
c]tification ! basis = su* d5ial1 &     
specifically id5tify ! f9d+ ^u :i* su*  

d5ial is bas$4  7ii7 ,if ! d5ial ( a    
reque/ z describ$ 9 clause 7i7 is bas$  
on gr\nds o!r ?an an injunction proce$+ 
pursuant to section #cjb1 seizure action
 pursuant to section #cjd1 or a recall  
designat$ ,class ,i or ,class ,,ii      
pursuant to "p #g1 title #ba1 ,code (   
,f$]al ,regulations1 ! ,secret>y %all   
provide a sub/antive summ>y ( ! specific
 defici5cies id5tifi$4  7iii7 ,) respect
 to a device manufactur$ 9 an e/abli%m5t
 t has receiv$ a report "u section      
#gjd7;b71 ! ,secret>y %all n d5y a      
reque/ = c]tification ) respect to a    
device pursuant to subp>agraph 7,a77ii7 
if ! ,secret>y & ! own]1 op]ator1 or    
ag5t 9 *>ge ( su* e/abli%m5t h agre$ to 
a plan ( correction 9 response to su*   
report4  7,f7 7i7 ,! ,secret>y %all     
provide a process = a p]son :o is d5i$ a
 c]tification z describ$ 9 subp>agraph  
7,e77i7 to reque/ a review t con=ms to !
 /&>ds ( section #eag;,a7b74  7ii7      
,not)/&+ any previ\s review conduct$    
pursuant to clause 7i71 a p]son :o has  

be5 d5i$ a c]tification z describ$ 9    
subp>agraph 7,e77i7 may at any "t reque/
 a review 9 ord] to pres5t new in=mation
 relat+ to actions tak5 by su* p]son to 
address ! reasons id5tifi$ by !         
,secret>y = ! d5ial ( c]tification1     
includ+ corrective actions to address   
defici5cies id5tifi$ by ! ,secret>y4    
7iii7 ,n lat] ?an #a ye> aft] date (    
enactm5t ( ?is subp>agraph1 ! ,secret>y 
%all issue guidance provid+ = a process 
to c>ry out ?is subp>agraph4  7,g7 7i7  
,subp>agraphs 7,e7 & 7,f7 apply to      
reque/s = c]tification on behalf ( any  
device e/abli%m5t regi/]$ "u section    
#eaj1 :e!r ! e/abli%m5t is locat$ 9 !   
,unit$ ,/ates or ano!r c\ntry4  7ii7 ,! 
,secret>y may *>ge a fee = ! issuance ( 
a c]tification describ$ 9 clause 7i71 & 
su* fee is subject to ! conditions &    
requirem5ts ( subp>agraph 7,b74  2 &    
7#b7 by mov+ ! m>g9s ( subp>agraphs 7,c7
 & 7,d7 #d ems to ! left4