Contains Nonbinding Recommendations 
 
 
Guidance for Industry  
and FDA Staff  
 
 
The Review and Inspection of 
Premarket Approval Application 
Manufacturing Information and 
Operations 
 
 
Document issued on: January 8, 2008 
 
The draft of this document was issued on June 19, 2006. 
 
For questions regarding this document contact Timothy A. Ulatowski at 240-276-0100 
(timothy.ulatowski@fda.hhs.gov) or James L. Woods at 240-276-0443 
(james.woods@fda.hhs.gov).  
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
Office of Compliance 
Office of In Vitro Diagnostic Device Evaluation and Safety 
 
 
 
Preface 
  Contains Nonbinding Recommendations 
 
Public Comment 
 
Written comments and suggestions may be submitted at any time for Agency consideration to 
the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, 
Room 1061, (HFA-305), Rockville, MD, 20852.     
 
Alternatively, electronic comments may be submitted to 
http://www.fda.gov/dockets/ecomments.  When submitting comments, please refer to Docket 
No. 2006D-0063.  Comments may not be acted upon by the Agency until the document is next 
revised or updated. 
 
Additional Copies 
 
Additional copies are available from the Internet at: 
http://www.fda.gov/cdrh/comp/guidance/1566.pdf,  You may also send an e-mail request to 
dsmica@fda.hhs.gov to receive an electronic copy of the guidance or send a fax request to 
240-276-3151 to receive a hard copy.  Please use the document number 1566 to identify the 
guidance you are requesting. 
ii   Contains Nonbinding Recommendations 
 
 
 
Guidance for Industry 
and FDA Staff  
 
 
The Review and Inspection of 
Premarket Approval Application 
Manufacturing Information and 
Operations 
 
  
 
This guidance represents the Food and Drug Administration's (FDA's) current thinking 
on this topic.  It does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public.  You can use an alternative approach if the approach 
satisfies the requirements of the applicable statutes and regulations.  If you want to discuss 
an alternative approach, contact the FDA staff responsible for implementing this 
guidance.  If you cannot identify the appropriate FDA staff, call the appropriate number 
listed on the title page of this guidance.  
 
Introduction  
 
The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) amended the 
Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 321 et seq.) to allow for the 
collection of user fees for the review of certain marketing applications.  A portion of the fee 
collected for premarket approval applications (PMAs) will help cover the costs associated 
with the review of the PMA manufacturing section information and the inspection of the 
manufacturing facilities.  In a letter to Congress that accompanied the user fee legislation, the 
Secretary of Health and Human Services committed to improve the scheduling and 
timeliness of preapproval inspections.1   
This guidance explains for applicants the process involved with the review of a PMA 
manufacturing section and inspection of the manufacturing operations described in the 
manufacturing section.  This guidance is also generally applicable to the process involved 
                                                           
1 This letter can be found at: www.fda.gov/cdrh/mdufma/pgoals.html Contains Nonbinding Recommendations 
 
with the review of manufacturing information in certain PMA supplements.  This guidance 
does not address premarket notification (510(k)) submissions because a premarket inspection 
is not ordinarily conducted for this type of premarket submission.  FDA believes that the 
procedural information outlined in this document should help applicants and FDA schedule 
and complete their work in a timely manner.   
 
The following will be addressed in this guidance: 
   
  The sequence of events as the Office of Compliance (OC) or the Office of In Vitro 
Diagnostic Device Evaluation and Safety (OIVD) reviews the manufacturing section 
of a PMA; 
  The administrative process and projected timeframes involved with each step; and 
  How the inspection of a manufacturing facility fits into the approval process. 
 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agency's current thinking on a topic and 
should be viewed only as recommendations, unless specific regulatory or statutory 
requirements are cited.  The use of the word should in Agency guidances means that 
something is suggested or recommended, but not required.  
 
The Least Burdensome Approach 
 
We believe we should consider the least burdensome approach in all areas of medical device 
regulation. This guidance reflects our careful review of the relevant scientific and legal 
requirements and what we believe is the least burdensome way for you to comply with those 
requirements. However, if you believe that an alternative approach would be less 
burdensome, please contact us so we can consider your point of view. You may send your 
written comments to the contact person listed in the preface to this guidance or to the CDRH 
Ombudsman. Comprehensive information on CDRH's Ombudsman, including ways to 
contact him, can be found on the Internet at  
http://www.fda.gov/cdrh/ombudsman/
 
Scope 
 
This guidance explains the administrative process used by OC or OIVD to review a PMAs 
Quality System (QS) regulation (21 CFR 820) information.  OC has already published 
guidance, entitled Quality System Information for Certain Premarket Application Reviews, 
which identifies the QS regulation information an applicant should include in the PMA 
manufacturing section.2  In addition, two corollary documents discuss generally the FDA 
review procedures and clock for PMAs, including the review of QS regulation information 
and the inspection process.  One document is entitled, FDA and Industry Actions on 
Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Performance 
                                                           
2 This guidance is available at: http://www.fda.gov/cdrh/comp/guidance/1140.html
 
2   Contains Nonbinding Recommendations 
 
Assessment.3   The other guidance is entitled, Premarket Approval Application Modular 
Review.4
 
Premarket Approval Applications 
 
The usual path to approval of a device is submission of a PMA, which may be traditional or 
modular, and expedited or non-expedited.5  When seeking premarket approval for your 
device, you should select the appropriate type of PMA submission based on the following: 
 
1.  Traditional PMA 
 
In this PMA format, you would submit all the elements required for a PMA, e.g., complete 
scientific and technical information about the device, manufacturing information, non-
clinical study information, and statistically valid and reliable data from clinical studies, at the 
same time in a single application, so we can determine whether there is a reasonable 
assurance that the device is safe and effective for its intended use.  For guidance on the type 
of information needed for FDA to file your PMA, see Premarket Approval Application 
Filing Review.6
 
2.  Modular PMA 
 
This PMA format consists of sections or modules submitted separately that together become 
a complete application.  Each module includes elements, tests, or other information that 
constitute a component of a complete PMA, such as manufacturing information or clinical 
data.  For more information on the Modular PMA Program, see the guidance entitled 
Premarket Approval Application Modular Review.4
 
3.  Expedited PMA (Traditional and Modular) 
 
We give priority to PMAs for devices under certain circumstances.  The Office of Device 
Evaluation (ODE) and OIVD determine, using criteria defined in section 515(d)(5) of the 
Act, whether a PMA qualifies for expedited status.  For more information on expedited 
PMAs, see the guidance entitled, Expedited Review of Premarket Submissions for 
Devices.7
 
B. Types of PMA Supplements 
 
                                                           
3  This guidance can be found at: www.fda.gov/cdrh/mdufma/guidance/1218.html
4 This guidance can be found at: www.fda.gov/cdrh/mdufma/guidance/835.html
5 The Product Development Protocol and, for devices that meet narrow criteria, the 
Humanitarian Device Exemption provide alternate approval mechanisms.  This guidance 
does not apply to these application types. 
6 This guidance can be found at: www.fda.gov/cdrh/ode/guidance/297.html
 
7 This guidance can be found at: http://www.fda.gov/cdrh/mdufma/guidance/108.html
 
3   Contains Nonbinding Recommendations 
 
You must submit a PMA supplement for review and approval if you make a change affecting 
the safety or effectiveness of a device for which you have an approved PMA.  (21 CFR 
814.39(a).)  Some changes do not require a supplement and some changes may be made 
using alternative forms of submission, as specified in FDA regulations.  MDUFMA added 
definitions to the FDC Act of several types of PMA supplements, including: panel-track 
supplements, 180-day supplements, and real-time supplements.  See FDC Act  737, 21 
U.S.C.  379. 
 
Panel-track and 180-day supplements may include manufacturing information.  If so, OC or 
OIVD will review the information and an inspection may be required, depending on the 
proposed change. When both a review of manufacturing information and an inspection are 
needed, the review process and timelines described in this guidance generally apply. 
Typically, there are no inspections associated with the following types of PMA submissions 
so they will not be addressed in this guidance:  
  Real-time supplements; 
  30-day notices;  
  135-day supplements;  
  Special PMA Supplements-Changes Being Affected; 
  Express PMA supplements; and  
  PMA annual reports. 
 
1.  Panel-track Supplements  
 
Section 737(4)(B) of the Act, which was added by section 102 of MDUFMA, defines a 
"panel-track supplement" as "a supplement to an approved premarket application or 
premarket report under section 515 that requests a significant change in design or 
performance of the device, or a new indication for use of the device, and for which 
substantial clinical data are necessary to provide a reasonable assurance of safety and 
effectiveness." (21 U.S.C. 379i (4)(B)). 
 
Panel-track supplements for changes in device design or performance that may significantly 
affect clinical outcome may require the submission of manufacturing information and an 
inspection. 
We give priority review to panel-track supplements meeting the criteria defined in section 
515(d)(5) of the Act.  Therefore, in the discussion below, references to expedited and non-
expedited PMAs include expedited and non-expedited panel-track supplements. 
 
2.  180-Day Supplements  
 
4   Contains Nonbinding Recommendations 
 
Under section 737(4)(C) of the Act, which was added by section 102 of MDUFMA, a "180-
day supplement" is defined as:  
 
"a supplement to an approved premarket application or premarket report under section 515 
that is not a panel-track supplement and requests a significant change in components, 
materials, design, specification, software, color additives, or labeling."  (21 U.S.C. 
379i(4)(C)) 
 
Read in conjunction with section 515(d)(6) of the Act, this language means that submission 
of a 180-Day Supplement is required for certain types of significant changes to the approved 
device that affect safety and effectiveness of the device.  In general, in order for a change to 
be submitted as a 180-Day Supplement, the clinical data provided in support of the original 
device approval should still be applicable in supporting the approval of the modified device.  
In most cases, for such modifications, only new pre-clinical testing is needed to demonstrate 
reasonable assurance of safety and effectiveness of the modified device.  In some instances, 
however, additional limited confirmatory clinical data may be necessary to provide a bridge 
between the clinical data set for the original device and the expected clinical performance of 
the modified device.  Although additional clinical data may be necessary, the data collected 
are usually from a limited number of patients.   Changes to devices that may require a 180-
Day Supplement include: 
  the principle of operation  
  the control mechanism  
  the device design or performance  
  the labeling  
  new testing requirements or acceptance criteria.  
 
A 180-day supplement involving changes to the design or manufacturing may require 
submission of manufacturing information and an inspection.  
 
C. The Review Process in Brief 
 
The premarket review process begins when the applicant submits six copies of a fileable 
PMA8 or three copies of a fileable PMA supplement9 to the CDRH Document Mail Center 
(DMC) in ODE.  Upon receipt, OC or OIVD will review the PMAs manufacturing section.  
OC or OIVD will request an inspection of the facility if one is needed.  There may be more 
than one manufacturing facility for an original PMA and a facility may be a domestic or 
foreign site.   
 
                                                           
8 See 21 CFR 814.20(b)(2). 
9 See 21 CFR 814.39(c). 
5   Contains Nonbinding Recommendations 
 
Following an inspection, OC or OIVD will receive and analyze the establishment inspection 
report for the manufacturing facility.  OC or OIVD will then make a recommendation to 
ODE on the status of the quality system for the facility.   
 
This guidance describes the timeframes within which FDAs review of the submission 
should be completed based on the goals set forth in the Congressional Record.  Significant 
deficiencies in the manufacturing information and/or manufacturing operations may result in 
more than one cycle of review.  Flow charts depicting the PMA manufacturing section 
review and inspection timelines are provided in Attachment A. 
 
FDA Review of the PMA Manufacturing Section, and the 
Inspection Process   
 
A. What procedure does FDA use to review a PMA manufacturing section?    
 
When a fileable PMA arrives at the ODE/DMC, the DMC processes the application as 
follows: 
 
1.  Logs in and tracks the submission.   
2.  Assigns due dates for the CDRH offices based on the date of receipt, e.g., 180 days 
after receipt. 
3.  Alerts the ODE Program Operations Staff (POS) of the incoming PMA.  
4.  Sends one complete copy of the PMA to OC Field Operations Branch (OC/FOB) 
within 7 calendar days of receipt. 
5.  Files one copy in the DMC. 
6.  Further processes the application administratively, prepares a transmittal coversheet, 
and forwards the document to the appropriate ODE review division or OIVD. 
 
When OC/FOB receives its copy of the PMA, it processes the document as follows:    
 
1.  OC/FOB assigns an internal tracking number for the PMA, establishes a due date (see 
Table 1) for the OC or OIVD review of the manufacturing information, and generates 
a transmittal coversheet.   
 
2.  The PMA with its transmittal coversheet are delivered to the appropriate enforcement 
division in OC, or to OIVD.  If clinical data are submitted in the PMA, OC/FOB 
forwards the clinical section to the OC Division of Bioresearch Monitoring (DBM) 
for review.   
 
Note: DBMs review and processing of the clinical and preclinical sections are 
addressed in a separate MDUFMA guidance, Guidance for Industry and Food and 
Drug Administration Staff: the Review and Inspection of Premarket Approval 
Applications Under the Bioresearch Monitoring Program. 
 
3.  OC/FOB alerts the district office associated with a domestic manufacturing site 
identified in the PMA as to the receipt of the application.  OC/FOB requests a 
6   Contains Nonbinding Recommendations 
 
response from the appropriate FDA district office within 7 calendar days regarding 
the inspection history of the manufacturing site.  If there are multiple facilities 
involved in the manufacturing process, OC/FOB will notify all relevant districts.   
 
The district will determine the following information concerning the manufacturing 
site from its records: 
   
a.  the date of last inspection; 
b.  classification of the last inspection report; and 
c.  the similarity of the products inspected to the PMA device and similarity of 
the manufacturing operations inspected by FDA to those used for the PMA 
device under review. 
 
Once the information is received from the district office, OC/FOB forwards the 
information to the assigned OC enforcement division, or to OIVD. 
 
4.  OC serves as the district office for any foreign facility.  OC, with input from OIVD 
when necessary, determines whether a foreign manufacturing facility requires an 
inspection based on the same information noted in item 3 above.   
 
For foreign sites, OC/FOB notifies the Office of Regional Operations (ORO), 
Division of Field Investigations (DFI), International Operations Branch (IOB) of a 
pending assignment.  ORO/DFI/IOG coordinates the foreign site inspections for the 
FDA field staff.  A provisional inspection assignment for a foreign facility is 
transmitted from OC/FOB to ORO/DFI/IOG early in the review process (see 
Attachment A).  This early assignment is done before completion of the 
manufacturing section review because foreign inspections take longer than domestic 
inspections to organize and complete due to scheduling, travel logistics, and 
coordinating with foreign governments and the U.S. State Department. The longer 
organizational time for a foreign inspection enables the assigned OC enforcement 
division or OIVD to substantially review the PMA manufacturing section and to 
cancel the inspection if there are major deficiencies.   
 
5.  The time frames indicated below in Table 1 are the performance goals for OC or 
OIVD to complete review of the PMA manufacturing section.10   
 
Table 1 
 
TYPE OF PMA  MANUFACTURING SECTION 
APPLICATION  REVIEW TIMEFRAME 
Non-Expedited Traditional   30 calendar days 
Expedited Traditional   20 calendar days 
Non-Expedited Modular  30 calendar days when submitted 
                                                           
10 Time frames for the QS/GMP review begin one day after FOB receives the PMA 
document from the DMC. 
 
7   Contains Nonbinding Recommendations 
 
with final module; up to 90 days if 
submitted prior to final module 
Expedited Modular  20 calendar days when submitted 
with final module; up to 90 days if 
submitted prior to final module 
180-Day Supplement  30 calendar days 
Amendment  20 or 30 calendar days depending 
on type of PMA amended 
               
B.  What happens when OC or OIVD completes its review of the PMA manufacturing 
section? 
   
The OC or OIVD reviewer (with supervisory concurrence) may:  (1) recommend that the 
manufacturing section is acceptable or (2) prepare a deficiency letter identifying significant 
deficiencies and requesting additional information from the applicant.  The OC or OIVD 
reviewer will also determine, with supervisory concurrence, whether an inspection is 
required.  
 
1.  If OC or OIVD determines that the PMAs manufacturing section is significantly 
deficient due to numerous omissions of information needed to assess the 
manufacturing operations, the applicant should expect to receive a deficiency letter 
identifying the specific information to submit to allow FDA to complete the review of 
the manufacturing section.  The OC or OIVD reviewer should communicate in real-
time with the applicant to clarify the number and type of deficiencies in a deficiency 
letter.  If there are only a few minor deficiencies, these will likely be handled by real 
time communication (e.g., phone, email and fax).  An extended response time by the 
applicant to a deficiency letter or to a real time communication for more information, 
or a delay in the submission of substantial additional manufacturing data, may 
significantly delay the completion of the initial review.  Submission of a response to a 
deficiency letter will begin a new 20, 30, or up to 90 day manufacturing section 
review timeframe depending on the type of application. (See Table 1.)     
 
2.  If the review of the manufacturing section is substantially complete and there are no 
deficiencies in the manufacturing section, or if the deficiencies have been adequately 
addressed through phone calls or additional submissions, OC or OIVD will evaluate 
the district offices inspection history of the domestic facility.  If OC or OIVD 
determines that FDA should conduct a QS/GMP inspection, OC/FOB will initiate an 
assignment with ORO for a domestic inspection.  OC/FOB will also confirm that the 
already initiated foreign inspection assignment should proceed. 
 
3.  The PMA applicant should be ready for inspection at the time of the filing of the 
PMA application unless the applicant states in the PMA that it is not ready.  The 
District (or OC for a foreign facility) should contact the facilitys management to 
alert them to the pending inspection.  At that time, the applicant should confirm that 
the facility is ready for inspection.  The manufacturing process should preferably be 
in operation by the time the inspection is conducted.  In any case, all process 
8   Contains Nonbinding Recommendations 
 
validations should be completed and the design successfully transferred into 
production.   
 
4.  OC/FOB plans to cancel the assigned or scheduled inspection under the following 
circumstances:  if the PMA is determined to be not fileable; ODE or OIVD issues a 
major deficiency letter, denial letter, withdrawal letter, or not approvable letter; or the 
applicant communicates to the FDA that the manufacturing site is not ready for 
inspection.   
 
If the facility is not ready for inspection, the District (or OC for a foreign facility) will 
ask the applicant to send a letter to the District or OC, signed by the most responsible 
person at the firm, indicating that they are not ready for inspection, the reason for not 
being ready, and when they expect to be ready.  This letter will be made part of the 
PMA record. 
 
The applicant should alert CDRH in writing or by real time communication in 
advance of when the facility will be ready for inspection.  OC/FOB will then reissue 
an inspection assignment and the inspection will be completed as stated in Section C.    
 
C.  How much time does the FDA allow for a PMA QS/GMP inspection? 
 
Domestic Inspections:   
FDA field staff should complete the inspection within 45 calendar days after receipt of the 
inspection assignment from OC or OIVD.   
 
Foreign Inspections:   
FDA field staff should complete the inspection within 60 calendar days after receipt of the 
inspection assignment.  Please note, foreign travel requires additional time for scheduling, 
travel logistics, and for coordinating with foreign governments and the U.S. State 
Department.   
 
An additional 30 calendar days are allotted for the field staff to write and forward a PMA 
application establishment inspection report to FOB for both domestic and foreign 
inspections.   
 
D. What happens after the establishment inspection report (EIR) is completed by the 
field staff? 
 
There are several potential outcomes from an inspection: 
 
  If FDA concludes that there are no objectionable conditions or practices with the 
manufacturing operations, or any that do not justify further regulatory action, i.e., 
a No Action Indicated (NAI) result, then OC/FOB will notify ODE POS that the 
PMA approval can proceed from a manufacturing operations perspective. 
 
  If FDA concludes that there are objectionable conditions or practices, but these do 
not warrant administrative or regulatory action, i.e., a Voluntary Action Indicated 
9   Contains Nonbinding Recommendations 
 
(VAI) result, then FDA may communicate the objectionable conditions or 
practices to the applicant and recommend that the applicant voluntarily correct the 
deficiencies. FDA may evaluate the corrections during a subsequent inspection.  
As above, OC/FOB will notify ODE POS that the PMA approval can proceed 
from a manufacturing operations perspective. 
 
  If FDA concludes that there are objectionable conditions or practices that warrant 
regulatory or administrative sanctions, i.e., an Official Action Indicated (OAI) 
result, then there are two possible outcomes: 
 
  1. If the conditions or practices pertain only to the pending PMA device, then 
OC or OIVD will issue a deficiency letter within 30 calendar days for a non-
expedited PMA and within 20 days for an expedited PMA. 
 
  2. If the conditions or practices pertain not only to the pending PMA device 
but also to marketed products, then FDA may issue a Warning Letter or Untitled 
Letter.   
 
In either case, the letter will inform the addressee that no approval for a pending PMA will 
issue until the objectionable conditions or practices are corrected.   
 
OC/FOB is informed of the issuance of a Warning or Untitled Letter by the 
issuing office.  Based upon the deficiencies noted in the Warning or Untitled 
Letter, OC/FOB will notify ODE POS when the manufacturing operation is not 
satisfactory and recommend that the PMA approval be withheld. ODE POS may 
then make the appropriate entry into the CDRH document tracking database.  If 
ODE or OIVD has completed its review of the PMA and concludes the PMA 
warrants an approval or approvable action, except for the unsatisfactory 
manufacturing aspects, ODE or OIVD will issue an approvable letter notifying 
the manufacturer of the pending GMP issues.  This letter stops the review clock 
for the PMA.   
 
The applicant should provide a complete response to the FDA office that issued 
the letter within the timeframe noted. A complete response to a deficiency, 
Warning or Untitled Letter begins a new 20 or 30 day FDA manufacturing section 
review period (See Table 1.)  More than one cycle of correspondence may be 
needed to resolve deficiencies.  Once deficiencies or violations appear to have 
been corrected, OC/FOB may issue a new inspection assignment, if needed, 
beginning a new cycle of review including the 45 or 60 day inspection as well as 
EIR completion and review by the District and OC or OIVD.  
   
E.  In summary, what is the general review cycle time for the manufacturing section and 
operations? 
 
Attachment A lists the internal FDA process phases and times involved with domestic and 
foreign inspections.  The inspection assignment phase and manufacturing review phase are 
 
concurrent.  In order to help meet the MDUFMA PMA performance goals, FDA plans to 
10   Contains Nonbinding Recommendations 
 
complete its review of the manufacturing information and the inspection within a total cycle time 
of approximately 140 days for a nonexpedited PMA and 120 days for an expedited PMA.   
 
F.  What are the most common factors that delay the review of a PMA manufacturing 
section or delay the inspection process? 
 
  When OC or OIVD issues a manufacturing section deficiency letter to a PMA applicant, 
a timely and thorough response facilitates the review process.  Until OC or OIVD 
receives the requested information, the review of the manufacturing section remains on 
hold and no inspection will be scheduled. 
 
  When a timely response is not received to real-time questions during the manufacturing 
section review and the milestone is exceeded (see Attachment A), FDA may issue a 
manufacturing section deficiency letter and/or an approvable pending GMP letter.   
 
  The manufacturing process should be in operation as soon as possible after PMA 
submission.  As noted, all process validations should be completed and the design 
successfully transferred into production.  Rescheduling a PMA inspection may result in 
further delays of the FDA review of the PMAs manufacturing section and operations and 
result in an approvable pending GMP letter. 
 
 
Attachment A    
Process Flow Charts 
11   Contains Nonbinding Recommendations 
 
 
OC MDUFMA  PMA Review Milestones in Total
FDA Calendar Days - Domestic Inspections
Day 0 CDRH Receives PMA
Day 7 FOB receives PMA
Day 22 (expedited)
Issue PMA Domestic QS/GMP
Day 32 (regular) Inspection Assignment w/out major
deficiencies (PMA filed)
Day 27(expedited) Manufacturing Section review
Day 37 (regular) completed (issue deficiency letter
where appropriate)
Day 67 (expedited Domestic QS/GMP
Day 77 (regular) Inspection  completed
Domestic Establishment
Day 97 (expedited) Inspection Report (EIR)
Day 107 (regular) completed
OC Domestic EIR Review
Day 117 (expedited)
completed
Day 137 (regular)
Recommendation
 
Attachment A 
Process Flow Charts 
12   Contains Nonbinding Recommendations 
 
 
OC MDUFMA  PMA Review  Milestones in Total
FDA Calendar Days - Foreign Inspections
Total Calendar Days
CDRH Receives
Day 0
PMA
Day 7
FOB receives PMA
Day 17 Provisional Foreign QS/
GMP Inspection Assignment
Notification
Manufacturing Section review
Day 27(expedited)
completed (issue deficiency letter
Day 37 (regular)
where appropriate)
Day 77 Foreign QS/GMP
Inspection  completed
Foreign
Day 107 Establishment
Inspection Report
(EIR) completed
Day 127 (expedited) OC  Foreign EIR Review
Day 137 (regular) completed
Recommendation
13