,,ii  #aaeth ,,congress  #ast ,session  
,s4 #djd  ,,in ,,the ,,senate ,,of ,,the
 ,,united ,,states  ,february #ae1      
#bjag,mr4 ,isakson 7for himself and ,mr4
 ,bennet7 introduced the following bill2
 which was read twice and referred to   
the ,committee on ,health1 ,education1  
,labor1 and ,pensions  ,a ,,bill  ,to   
amend the ,federal ,food1 ,drug1 and    
,cosmetic ,act to improve the process   
for inspections of device establishments
 and for granting export certifications4
  #a4 ,findings ,congress finds as      
follows3 7#a7 ,there is a lack of       
transparency and consistency concerning 
inspections by the ,food and ,drug      
,administration of medical device       
establishments around the world1 which  
leads to inefficiencies and             
inconsistencies and undermines          
confidence in ,united ,states standards4
  7#b7 ,inspections by the ,food and    
,drug ,administration of foreign device 
establishments are often conducted more 
efficiently than inspections of domestic

 device establishments4  7#c7 ,the      
frequency and nature of inspections of  
device establishments are not           
consistently risk-based1 and a          
comprehensive1 transparent1 risk-based  
approach to inspections would result in 
greater focus on the more significant   
risks to public health while reducing   
the burdens on establishments with a    
strong track record of compliance4  7#d7
 ,there is a lack of transparency and   
consistency among ,united ,states-based 
regional inspection offices with respect
 to the frequency of inspections of     
device establishments and the activities
 and concerns that trigger for-cause    
inspections of such establishments4     
7#e7 ,greater transparency concerning   
the timing and nature of routine        
inspections of device establishments    
would improve the quality and efficiency
 of the inspection process4  7#f7       
,enhancing communications before1       
during1 and after inspections in which  
deficiencies are identified1 would      

assist the ,secretary of ,health and    
,human ,services and the device industry
 in maintaining the safety and          
effectiveness of devices4  7#g7         
,guidance for device establishments is  
necessary to provide transparency and   
consistency concerning                  
inspection-related communications4  7#h7
 ,enhanced training opportunities for   
device establishment investigators would
 improve the consistency and efficiency 
of the device inspection process4  7#i7 
,there is a lack of transparency in the 
export certification process with       
respect to device establishments for    
which ,,fda ,form #dhc has been used to 
document issues noticed during an       
inspection conducted pursuant to section
 #gjd of the ,federal ,food1 ,drug1 and 
,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7 or  
establishments that have received       
,warning ,letters in connection with    
such an inspection1 and between domestic
 and foreign establishments1 resulting  
in devices that are lawfully marketed   

for ,united ,states patients being      
denied certification for marketing in   
other countries4  7#aj7 ,device         
establishments that have attempted to   
address deficiencies identified by      
inspections carried out by the ,food and
 ,drug ,administration lack sufficient  
opportunities to confirm that such      
corrective actions are appropriate4  #b4
 ,risk-based inspections for devices    
,paragraph 7#b7 of section #eaj7;h7 of  
the ,federal ,food1 ,drug1 and ,cosmetic
 ,act 7#ba ,u4,s4,c4 #cfj7;h77 is       
amended to read as follows3  7#b7       
,risk-based schedule for devices  7,a7  
,in general ,the ,secretary1 acting     
through one or more officers or         
employees duly designated by the        
,secretary1 shall inspect establishments
 described in paragraph 7#a7 that are   
engaged in the manufacture1 propagation1
 compounding1 or processing of a device 
or devices 7referred to in this         
subsection as device establishments7 in 
accordance with one risk-based          

inspection schedule established by the  
,secretary1 applied consistently across 
regional offices4  7,b7 ,factors and    
considerations ,in establishing the     
risk-based schedule under subparagraph  
7,a71 the ,secretary shall-- 7i7 apply1 
to the extent applicable for device     
establishments1 the factors identified  
in paragraph 7#d72 and  7ii7 consider   
the participation of the device         
establishment1 as applicable1 in        
international device audit programs in  
which the ,united ,states participates  
or the ,united ,states recognizes for   
purposes of inspecting4  4  #c4         
,improvements to inspections process for
 device establishments ,section #gjd of 
the ,federal ,food1 ,drug1 and ,cosmetic
 ,act 7#ba ,u4,s4,c4 #cgd7 is amended by
 adding at the end the following3  7h7  
7#a7 ,the ,secretary shall adopt a      
uniform process and uniform standards   
applicable to inspections of domestic   
and foreign device establishments4 ,such
 process shall include--  7,a7 notifying

 the owner1 operator1 or agent in charge
 of the establishment of the type and   
nature of the inspection2  7,b7         
announcing the inspection the           
establishment within a reasonable time  
before such inspection2  7,c7 in the    
case of inspections other than for-cause
 inspections1 providing a reasonable    
estimate of the timeframe for the       
inspection1 an opportunity for advance  
communications between the officers or  
employees carrying out the inspection   
under subsection 7a77#a7 and the owner1 
operator1 or agent in charge of the     
establishment concerning appropriate    
working hours during the inspection1    
and1 to the extent feasible1 advance    
notice of records that will be requested
 in order to expedite the inspection2   
and  7,d7 daily communications with the 
owner1 operator1 or agent in charge of  
the establishment regarding inspection  
status1 which may be recorded by either 
party with advance notice4  7#b7 ,in the
 case of device establishments that have

 received a report pursuant to          
subsection 7b71 and for which the owner1
 operator1 or agent in charge of such   
establishment submits a timely response 
to such report that includes a request  
for feedback to the actions proposed in 
such response1 the ,secretary shall     
provide nonbinding feedback regarding   
such proposed actions within #de days of
 receipt of such request4  7#c7 ,nothing
 in this subsection limits the authority
 of the ,secretary to conduct           
inspections otherwise permitted under   
this ,act in order to ensure compliance 
with this ,act4  7#d7 7,a7 ,not later   
than #a year after the date of enactment
 of this subsection1 the ,secretary     
shall issue draft guidance that--  7i7  
specifies how the ,food and ,drug       
,administration will implement the      
process described in paragraph 7#a7 and 
the requirements described in paragraph 
7#b72  7ii7 provides for standardized   
templates for communications described  
in such paragraphs2  7iii7 establishes a

 standard timeframe over consecutive    
days that is applicable to both domestic
 and foreign inspections1 to which each 
inspector shall adhere unless an        
investigator can identify to the        
establishment a reason that more time is
 needed2 and  7iv7 identifies practices 
for investigators and device            
establishments to facilitate the        
continuity of inspections4  7,b7 ,not   
later than #ah months after the date of 
enactment of this subsection1 after     
notice and opportunity for public       
comment on the draft guidance described 
in subparagraph 7,a71 the ,secretary    
shall issue final guidance consistent   
with this subsection4  4  #d4           
,certificates to foreign governments for
 devices ,subsection 7e77#d7 of section 
#hja of the ,federal ,food1 ,drug1 and  
,cosmetic ,act 7#ba ,u4,s4,c4           
#cha7;e77#d77 is amended--  7#a7 by     
adding at the end the following3  7,e7  
7i7 ,if the ,secretary denies a request 
for certification with respect to a     

device pursuant to subparagraph         
7,a77ii71 the ,secretary shall provide  
in writing to the person seeking such   
certification the basis for such denial1
 and specifically identify the finding  
upon which such denial is based4  7ii7  
,if the denial of a request as described
 in clause 7i7 is based on grounds other
 than an injunction proceeding pursuant 
to section #cjb1 seizure action pursuant
 to section #cjd1 or a recall designated
 ,class ,i or ,class ,,ii pursuant to   
part #g1 title #ba1 ,code of ,federal   
,regulations1 the ,secretary shall      
provide a substantive summary of the    
specific deficiencies identified4  7iii7
 ,with respect to a device manufactured 
in an establishment that has received a 
report under section #gjd7;b71 the      
,secretary shall not deny a request for 
certification with respect to a device  
pursuant to subparagraph 7,a77ii7 if the
 ,secretary and the owner1 operator1 or 
agent in charge of such establishment   
have agreed to a plan of correction in  

response to such report4  7,f7 7i7 ,the 
,secretary shall provide a process for a
 person who is denied a certification as
 described in subparagraph 7,e77i7 to   
request a review that conforms to the   
standards of section #eag;,a7b74  7ii7  
,notwithstanding any previous review    
conducted pursuant to clause 7i71 a     
person who has been denied a            
certification as described in           
subparagraph 7,e77i7 may at any time    
request a review in order to present new
 information relating to actions taken  
by such person to address the reasons   
identified by the ,secretary for the    
denial of certification1 including      
corrective actions to address           
deficiencies identified by the          
,secretary4  7iii7 ,not later than #a   
year after date of enactment of this    
subparagraph1 the ,secretary shall issue
 guidance providing for a process to    
carry out this subparagraph4  7,g7 7i7  
,subparagraphs 7,e7 and 7,f7 apply to   
requests for certification on behalf of 

any device establishment registered     
under section #eaj1 whether the         
establishment is located in the ,united 
,states or another country4  7ii7 ,the  
,secretary may charge a fee for the     
issuance of a certification described in
 clause 7i71 and such fee is subject to 
the conditions and requirements of      
subparagraph 7,b74  2 and  7#b7 by      
moving the margins of subparagraphs 7,c7
 and 7,d7 #d ems to the left4