Guidance for Industry and FDA 
Staff 
 
Premarket Approval Application 
Modular Review 
 
Document issued on: November 3, 2003  
 
This document supersedes and replaces, A Modular Approach to PMA 
Review, dated January 29, 1998, and Guidance for the Medical Device 
Industry on PMA Shell Development and Modular Review, dated 
November 6, 1998. 
 
For questions regarding this document, contact Thinh Nguyen (CDRH) at 240-276-4010 or 
by e-mail at thinh.nguyen@fda.hhs.gov.  For questions regarding the application of this guidance to 
devices regulated by the Center for Biologics Evaluation and Research (CBER), contact 
Robert Yetter at (301) 827-0373 or by e-mail at Yetter@cber.fda.gov. 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
 
Center for Biologics Evaluation and Research 
 
  Contains Nonbinding Recommendations 
 
Preface 
 
Public Comment 
Written comments and suggestions may be submitted at any time for Agency consideration to 
Dockets Management Branch, Division of Management Systems and Policy, Office of Human 
Resources and Management Services, 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.  Please identify your comments with the 
docket number listed in the notice of availability that publishes in the Federal Register 
announcing the availability of this guidance document.  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/mdufma/guidance/835.pdf or 
http://www.fda.gov/cber/mdufma/mdufma.htm, or by phone at (301) 827-2000 or (800) 835-
4709, or to receive this document by fax, call the CDRH Facts-On-Demand system at 800-
899-0381 or 301-827-0111 from a touch-tone telephone.  Press 1 to enter the system.  At the 
second voice prompt, press 1 to order a document.  Enter the document number (835) 
followed by the pound sign (#).  Follow the remaining voice prompts to complete your 
request.   
  Contains Nonbinding Recommendations 
 
Table of Contents 
 
I.  Purpose.............................................................................................................................1 
 
II.  Background.................................................................................................................1 
   
The Least Burdensome Approach.........................................................................................3 
 
III.  Consultation with Stakeholders.................................................................................3 
   
IV.  Scope.............................................................................................................................4 
   
V.  Definitions........................................................................................................................4 
   
VI.  User Fee Considerations for Modular Review.........................................................4 
   
VII.  Industry Instructions for Submitting a Modular PMA...........................................5 
 
Contact Review Group..................................................................................................5 
A. PMA Shell....................................................................................................................5 
   
1.  Determination that PMA Review is Appropriate for the Device..........................5 
2.  Content of a PMA Shell........................................................................................6 
3.  Informal Review of the Proposed PMA Shell......................................................7 
4.  Submission of the PMA Shell...............................................................................7 
5. Changes to the Accepted PMA Shell........................................................................7 
B. PMA Modules..............................................................................................................8 
 
1. Submission of Each PMA Module...........................................................................8 
2. Incomplete PMA Modules........................................................................................8 
3. Time Frame for Reviewing a PMA Module.............................................................8 
4. Reopening a Closed PMA Module ...........................................................................9 
5. Submission of the Final PMA Module.....................................................................9 
6. Filing of the Modular PMA......................................................................................9 
 
Attachment I Modular PMA Flow......................................................................................11 
   
Attachment II  Sample PMA Shell......................................................................................12 
     
Attachment III  Frequently Asked Questions ....................................................................13 
   
 
 
  Contains Nonbinding Recommendations 
 
Guidance for Industry and FDA Staff 
 
Premarket Approval Application Modular 
Review 
 
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.  
 
I.  Purpose 
The purpose of this guidance document is to provide industry and FDA staff with 
information regarding the premarket approval application (PMA) modular review program 
and to outline the procedures for submitting or reviewing a modular PMA.   
 
This guidance supersedes and replaces the documents entitled, A Modular Approach to 
PMA Review, dated January 29, 1998, and Guidance for the Medical Device Industry on 
PMA Shell Development and Modular Review, issued on November 6, 1998 (hereinafter 
referred to as the 1998 Guidances). 
 
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. 
 
II.  Background 
In a traditional PMA, the applicant submits all PMA data, as outlined in 21 CFR 814.20, at 
the same time, regardless of when testing is completed.  FDA begins its review only upon 
receipt of all the required information.  In 1998, however, as part of CDRHs reengnineering 
effort, FDA issued the above mentioned guidances.  In these documents, FDA described a 
new policy whereby applicants could submit Modular PMAs.  The goal of FDAs 1998 
Guidances was to increase the efficiency of the PMA review process by allowing applicants 
to submit discrete sections (modules) of the PMA to FDA for review soon after completing 
the testing and analysis. 
 
  1  Contains Nonbinding Recommendations 
 
FDA intends the modular review approach to provide a mechanism by which applicants may 
submit preclinical data and manufacturing information for review while still collecting, 
compiling, and analyzing the clinical data.  Therefore, a modular PMA is a compilation of 
sections or "modules" submitted at different times that together become a complete 
application.  Additionally, the modular approach allows the applicant to potentially resolve 
any deficiencies noted by FDA earlier in the review process than would occur with a 
traditional PMA application.   
 
On October 26, 2003, the Medical Device User Fee and Modernization Act of 2002 
(MDUMFA), Public Law 107-250 was enacted.  Section 209 of MDUFMA amended the 
Federal Food, Drug and Cosmetic Act (the act) to codify the modular review approach.1  In 
recognition that the agency would need to issue updated guidance to reflect the new statutory 
provision, FDA requested comments on its modular PMA review program.  On February 4, 
2003, FDA published a Federal Register notice entitled, Medical Device User Fee and 
Modernization Act of 2002, Establishment of a Public Docket (68 FR 5643)(hereinafter 
referred to as the MDUFMA Docket).  In addition, FDA issued a guidance entitled, 
Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy 
Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for 
Combination Products.2  In the guidance, FDA asked for comments on the various topics 
discussed in the document, including modular review of PMAs. 
 
Since 1998, FDA has gained considerable experience with modular PMA submissions.  
Based on FDAs experience prior to the enactment of MDUFMA and comments submitted to 
the MDUFMA Docket, FDA is issuing this guidance to replace the 1998 Guidances.  These 
changes include:  
 
  clarifying that modular review should be limited to original PMAs (i.e., modular 
review is not ordinarily appropriate for PMA supplements) 
  modifying the procedures for preparing and submitting a modular PMA 
  explaining the significance of timing for submission of the modules 
  revising the sample shell and specifying the expected content of the modules 
  suggesting limitations to the total number of modules that should be submitted. 
 
The agency expects these changes to: 1) help clarify which PMAs are appropriate for 
modular review, 2) simplify submission procedures, and 3) improve the efficiency of FDAs 
review.  Additionally, we have added guidance addressing user fee payment procedures for 
modular PMAs.  
 
                                                 
1 Section 515(c) of the act, as amended by section 209 of MDUFMA.  
2 This guidance was issued on February 25, 2003 and can be found at 
www.fda.gov/cdrh/mdufma/guidance/1201.html  (hereinafter referred to as the Assessing 
User Fees guidance.) 
  2  Contains Nonbinding Recommendations 
 
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 
or CBER Ombudsman.  Comprehensive information on CDRH's Ombudsman, including ways 
to contact him, can be found on the Internet at 
http://www.fda.gov/cdrh/resolvingdisputes/ombudsman.html and CBERs Ombudsman can 
be reached at (301) 827-0379.  
 
III.  Consultation with Stakeholders 
In developing this guidance, FDA has considered comments on the PMA modular review 
program that were submitted to the MDUFMA Docket.  As mentioned above, FDA also 
issued the Assessing User Fees guidance and asked for comments on modular review in that 
document.3    
 
To date, FDA has received comments on modular PMA review submitted to the MDUFMA 
docket from one stakeholder.  One comment requested that FDA expand the scope of 
modular review, now limited to original PMAs, to certain PMA supplements.  In the 
agencys experience, reviews of applications that are supplements to an already approved 
device do not ordinarily lend themselves to a modular format because the changes do not 
usually involve multiple modules.  In addition, the agency currently does not have the 
resources that would be required to expand the program.  Therefore, this guidance addresses 
procedures solely for the modular review of original PMAs.   
 
Another comment requested that FDA respond to incomplete modules in an abbreviated 
timeframe (i.e., 75 days rather than the 90 review that traditionally has been used by the 
agency).  At this time, FDA believes that the current review timeframe represents a realistic 
projection of what the Food and Drug Administration's Center for Devices and Radiological 
Health and Center for Biologics Evaluation and Research can accomplish.  However, as 
stated in the letter from the Secretary of Health and Human Services to Congress that 
accompanies the user fee legislation,4 FDA agreed to work with its stakeholders to develop 
appropriate performance goals for this program once it is fully implemented.  FDA will also 
re-examine the modular review timeframe at that time. 
 
One comment requested that FDA assess user fees on modular PMAs only if the initial 
module was submitted on or after October 1, 2002.  FDA agrees with this comment and will 
not assess user fees retroactively for modular PMAs first submitted before October 1, 2002.   
 
                                                 
3 This guidance can be found on the CDRH website at:  
http://www.fda.gov/cdrh/mdufma/guidance/1201.html. 
4 This letter can be found at: www.fda.gov/cdrh/mdufma/pgoals.html. 
  3  Contains Nonbinding Recommendations 
 
Finally, one comment requested FDA to develop a question and answer styled text explaining 
PMA modular review.  We have done so and included it as an attachment to this guidance 
document. 
 
We continue to invite comments on this guidance.  In addition, the agency intends to include 
the modular review program as a topic for discussion at future stakeholder meetings.    
 
IV.  Scope 
The PMA modular review program affords an alternative to the preparation, submission, and 
evaluation of traditional premarket approval applications (PMAs).  Because FDA believes 
that PMA supplements would rarely be appropriate for modular review, the scope of this 
document is limited to applicants pursuing approval of original PMAs.   
 
V.  Definitions 
Modular PMA is a compilation of sections or "modules" submitted at different times that 
together become a complete PMA application.   
 
PMA Module is a discrete section of the PMA that can be submitted and reviewed 
independently.  A module is a set of elements, tests, information, etc., that addresses a 
selected aspect of the device application, such as manufacturing or animal testing. 
   
PMA Module Amendment is information an applicant submits to FDA to modify a pending 
module. 
 
PMA Module Supplement is information submitted to a closed module for FDA review of a 
change or modification to the information provided in the original module. 
 
PMA Shell is an outline and description of the contents of all the modules that will comprise 
the PMA.  
 
VI.  User Fee Considerations for Modular Review 
MDUFMA amends the act to provide FDA new responsibilities, resources, and challenges. 
One significant provision of MDUFMA permits FDA to collect user fees for certain 
premarket reviews (i.e., premarket approval applications, premarket reports, supplements, 
premarket notifications, biologics license applications, and efficacy supplements as discussed 
in more detail below) for those applications received on or after October 1, 2002. On 
February 20, 2003, enabling appropriations were enacted, thus allowing the agency to 
immediately begin to collect fees for medical device applications.  Please see 
http://www.fda.gov/oc/mdufma for information on remitting user fees. 
 
  4  Contains Nonbinding Recommendations 
 
As discussed in previous guidance on user fee payments for modular PMAs,5 the fee for a 
modular PMA is due upon submission of the first module.  If FDA receives the first module 
prior to payment, we will place the file on hold until we receive payment and notify the 
applicant of this action by facsimile.6  FDA begins its review when the Office of Financial 
Management notifies CDRH or CBER that payment has been received. 
 
VII. Industry Instructions for Submitting a Modular 
PMA  
Contact Review Group 
Attachment I contains a flow chart of the steps ordinarily involved in modular PMA 
review.  The first step in the modular PMA process should be contacting the CDRH 
Branch Chief within the appropriate review division or the applications division in the 
appropriate CBER Office to indicate your intention to submit a modular PMA.7  FDA 
believes early interaction with the appropriate branch/division and continued 
communication will optimize the opportunity for success of the modular PMA.   
 
A. PMA Shell 
 
1. Determination that PMA Review is Appropriate for the 
Device  
Immediately upon receipt of an informal request for modular review, the 
Branch Chief assigns review staff (or other personnel designated by the 
division).  That person answers a set of preliminary questions (please see 
Premarket Approval Application Filing Review; Guidance for Industry 
and FDA) aimed at ensuring that FDA utilizes the appropriate regulatory 
review path.  Depending upon the answers to these preliminary questions, 
regulation as a class III device may be inappropriate.  If the responses to the 
preliminary questions indicate that review of the modular proposal should not 
continue, staff notifies the applicant using the procedures identified in the 
guidance document referenced above.  
                                                 
5 Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and 
Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and 
Fees for Combination Products can be found at: 
www.fda.gov/cdrh/mdufma/guidance/1201.html 
6 Section 209 of MDUFMA authorizes FDA to put the application on hold until payment is 
received. 
7 For assistance in identifying the appropriate review branch, the applicant may contact the 
Division of Small Manufacturers, International, and Consumer Assistance (DSMICA).  
Please see http://www.fda.gov/cdrh/devadvice/36f.html for contact options.  For assistance in 
identifying the appropriate division in CBER, please contact the Office of Communication, 
Training and Manufacturers Assistance at 1-800-835-4709 or please see 
http://www.fda.gov/cber/inside/orgover.pdf. 
  5  Contains Nonbinding Recommendations 
 
 
2.  Content of a PMA Shell 
FDA recommends that applicants use the sample PMA shell (Attachment II 
Sample PMA Shell) as a model when designing PMA shell proposals.  In your 
PMA shell proposal, you should describe the contents of each module in 
sufficient detail to provide FDA with a complete understanding of the 
modules you plan to submit.  The PMA shell proposal should address all 
elements required under 21 CFR 814.20 Application and the timing of each 
modular submission.     
 
If the clinical trial period will be lengthy or the product development time line 
is long, you should carefully consider your schedule for submitting PMA 
modules when developing your PMA shell.  Premature submission of PMA 
modules (i.e., prior to finalizing your device design) could result in changes to 
the device that require you to submit additional data and FDA to re-evaluate 
closed PMA modules. 
 
FDA may refuse to accept a proposal for a PMA shell if the timing is 
inappropriate.  For example, if you are within 6 months or less of submitting 
the final PMA module, FDA believes PMA modular review may not be 
appropriate because it may not allow sufficient time for FDA to complete its 
review of all the modules before receiving the final PMA module.   
 
In addition, with the exception of the manufacturing module, applicants 
should not plan to submit PMA modules in close succession.  The schedule 
for submitting PMA modules should allow enough time for the review 
division to complete review of one module before the next module is received.  
Submitting PMA modules for concurrent review undermines the purpose of 
the modular review program because the agency cannot review multiple 
modules on an abbreviated cycle.  If you intend to submit several modules at 
the same time or in close succession, FDA recommends that you submit a 
traditional PMA. 
 
The exception to this is the manufacturing module, which may be submitted at 
any time, regardless of when other modules were submitted.  This is 
appropriate because the Office of Compliance, CDRH has primary 
responsibility for reviewing this data.  Similarly, in CBER, the manufacturing 
section is reviewed by the Office of Biologics Quality.  Therefore, FDA can 
efficiently concurrently review the manufacturing module, while another 
module is being reviewed.  The manufacturing information should be 
submitted as a separate module to allow for ease of distribution to and review 
by the appropriate office.   
 
Please notify FDA, in the form of an amendment to your shell, when you 
anticipate that you are within 90 days of submitting your final PMA module, 
  6  Contains Nonbinding Recommendations 
so that FDA can schedule a pre-approval Quality System Regulation 
inspection. 
3. Informal Review of the Proposed PMA Shell
After you contact the appropriate Branch Chief, and it is agreed that PMA is 
the appropriate regulatory path, you should fax or email a draft of the 
proposed PMA shell to the branch chief to allow for review and comment on 
the proposal.  The Branch Chief assigns a staff member to review the 
proposed shell.  This individual is responsible for communicating to you any 
FDA recommended changes and reaching verbal agreement with you on the 
shell.8 
4. Submission of the PMA Shell
After you reach agreement with FDA on the proposed PMA shell, you should 
submit the finalized shell to the following address, as applicable:   
PMA Document Mail Center - WO66-G609
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002  
Or to CBER at: 
Food and Drug Administration
Center for Biologics Evaluation and Research
Document Control Center, HFM-99, Suite 200N
Rockville, MD 20852-1448
In order to facilitate the log-in process, you should prominently identify the 
name of the review staff member with whom you have been interacting in 
your cover letter.  After the FDA receives the PMA shell and assigns a unique 
document control number (shell number), the review staff will confirm that 
the PMA shell is consistent with the agreed upon proposal and issue an 
acceptance letter (usually within 2 weeks).  You may then submit PMA 
modules for review, according to the agreed upon schedule.   
5. Changes to the Accepted PMA Shell
If you need to make changes to the shell after it has been accepted (e.g., 
device design modifications are made that require additional or different 
testing or the number of necessary modules increases or decreases), you 
should submit an amendment to the shell with a description of the changes 
8 If agreement cannot be reached with the review staff assigned to review the shell within 30-
days, please contact branch/division management.  
7  Contains Nonbinding Recommendations 
 
and an explanation of the need for changes.  After reviewing these changes, 
FDA may wish to discuss them with you.  Once verbal agreement has been 
reached, you should submit the revised shell to the appropriate address listed 
above. 
 
B. PMA Modules 
 
1.  Submission of Each PMA Module 
When submitting a module, you should clearly identify the submission as a 
module and reference the previously assigned shell number (and module 
number) in the cover letter.  As outlined in Attachment II Sample PMA Shell, 
you should include the following in every module:  
 
  cover letter; 
  table of contents; 
  executive summary of the testing and results included in the module; 
  device description and principles of operation; and 
  bibliography (with references only to articles relevant to that module).   
 
Duplication of some information between modules is necessary to allow the 
review staff assigned to that PMA module to review it in an efficient manner.   
 
2.  Incomplete PMA Modules  
The full benefit of PMA modular review to both FDA and the applicant 
cannot be realized if PMA module submissions are routinely incomplete.  
Therefore, you should complete all testing to support the specific PMA 
module before submitting the module to FDA for review.  FDA may reject an 
incomplete module by issuing a letter to the applicant stating that the review 
may not proceed until we receive the missing information.  FDA intends to 
review each module within a 90-day time period, beginning upon submission 
of an amendment containing the balance of the missing information.   
 
3.  Time Frame for Reviewing a PMA Module 
FDAs objective is to complete the review of each module and issue a 
deficiency letter or an acceptance letter within 90 days of receipt of the 
module.  Deficiency letters notify the applicant of outstanding issues that need 
clarification or additional information.  Acceptance letters notify the applicant 
that all issues have been resolved.   
 
FDA intends to review any amendments responding to a deficiency letter 
under a 90-day clock.  Submitting any unsolicited major amendment at any 
time during the review of the PMA module resets the 90-day clock.  Major 
amendments are defined in 21 CFR 814.37(c)(1). 
 
  8  Contains Nonbinding Recommendations 
 
4.  Reopening a Closed PMA Module 
If you modify your device after FDA deems a PMA module acceptable, you 
should contact the appropriate review division staff to discuss the 
modification and any testing needed to support it.  You should submit data 
generated to support the modification separately to each of the affected 
modules with a revised executive summary.  FDA logs-in this type of 
submission as a supplement to the PMA module.  As described above, FDA 
intends to issue a deficiency or acceptance letter within 90 days of receipt of 
the supplement.  
 
5.  Submission of the Final PMA Module 
An applicants submission of the final PMA module (i.e., final clinical data, 
proposed labeling, and summary of safety and effectiveness), plus the 
incorporation by reference of previously submitted modules, will complete the 
modular PMA.  You should clearly identify the final PMA module submission 
as the COMPLETED MODULAR PMA in the cover letter.  You should 
specifically reference (by shell and module numbers) the modules that have 
been accepted by the FDA and also identify any modules with outstanding 
deficiencies at the time of PMA submission.  In order for the PMA to be 
complete, responses to all outstanding deficiencies related to previously 
submitted modules should accompany the final PMA module.  
 
Upon receipt of this final PMA module, FDA assigns a PMA number to the 
completed application. 
 
6.  Filing of the Modular PMA 
 
Upon receipt of the final module, FDA makes its filing decision.  This 
decision is based on whether the last module includes all the information 
necessary to complete the PMA as required by 21 CFR 814.20.  The PMA 
Filing guidance9 describes the kind of information required under this 
regulation that needs to be submitted before FDA can file a PMA.  FDA plans 
to use the information described in this guidance in making filing 
determinations and, as for a traditional PMA, generally issues a filing/non-
filing letter within 45 days of receipt of the last module.  If FDA decides to 
file the PMA, the filing date is the date that the application became complete, 
typically the receipt date of the last module.  The 180-day "PMA clock" under 
                                                 
9 See Premarket Approval Application Filing Review at 
www.fda.gov/cdrh/ode/guidance/297.html 
 
  9  Contains Nonbinding Recommendations 
 
21 CFR 814, also begins on that date.  If the agency decides not to file the 
PMA, FDA will issue a non-filing letter to the PMA applicant.  
  10  Contains Nonbinding Recommendations 
 
Attachment I Modular PMA Flow 
 
 
 
 
  Based on preliminary questions found in 
  Premarket Approval Application 
  Filing Review; Guidance for Industry 
  and FDA, PMA is determined to be the 
  appropriate regulatory path.  
 
 
Applicant submits informal PMA Shell to the attention of the CDRH Branch 
Chief of the appropriate review division or to the applications division in the 
appropriate CBER office. 
 
Applicant reaches 
agreement with FDA 
Applicant submits final PMA Shell to DMC or DCC 
 
Review division sends a letter to the applicant 
accepting the shell  
Applicant submits user 
fee payment before 1st 
PMA module 
Applicant submits PMA modules in accordance with 
agreed upon schedule (each module subject to a 90-day 
review clock) 
Applicant submits final PMA module, thereby completing 
the Modular PMA (180-day review clock) 
  11  Contains Nonbinding Recommendations 
 
Attachment II  Sample PMA Shell 
Company/Device Name  
Module #  Contents  Projected Date 
of Submission 
Module 1  Table of Contents for Module 1   
*
Executive Summary  
Device Description and Principles of Operation 
Declaration of Conformance to Standards for Module 1 
Bibliography/References for Module 1 
Non-clinical Laboratory Studies, for example:  
  Physico-Chemical Testing 
  Biocompatability/Toxicity Testing 
  Animal/Biological Testing 
Module 2  Table of Contents for Module 2   
Executive Summary*  
Device Description and Principles of Operation 
Declaration of Conformance to Standards for Module 2  
Bibliography/References for Module 2 
Non-clinical Laboratory Studies, for example: 
  Engineering/Bench Testing 
  Sterilization, Shelf Life & Packaging Information 
(Pertinent information should also be provided in 
the manufacturing section) 
  Software Validation and Verification Information 
Module 3  Table of Contents for Module 3   
Executive Summary*  
Device Description and Principles of Operation 
Manufacturing Information 
  Refer to Quality System Information for Certain 
Premarket Application Reviews; Guidance for 
Industry and FDA Staff (February 2, 2003) 
Final PMA  Table of Contents for entire PMA, including all modules   
Module  SSED (i.e., compilation of executive summaries) 
Clinical Data (including Protocols, Results and Analyses) 
Financial Disclosure Information 
Proposed Labeling: 
  Physician Instructions 
  Patient Instructions 
  Operation Manuals 
Post-marketing Plan (e.g., proposed long-term follow up 
studies, if appropriate) 
Bibliography/References for the Final PMA Module 
                                                 
*
 Executive Summary should contain a summary of the testing and results provided in the 
module. 
  12  Contains Nonbinding Recommendations 
 
 
Attachment III  Frequently Asked Questions 
 
1.  What is the sample Modular PMA Shell?  
An example of a sample Modular PMA shell is provided in Attachment II of this guidance 
document.  FDA recommends that you follow this model whenever possible.  Ideally, there 
should be no more than 3-4 modules.  However, we understand that there may be instances 
when the recommended model is not suitable and should be modified.  The review staff will 
work with you to establish a shell that is acceptable to both parties.   
 
2.  What should I consider when deciding whether to submit a Modular PMA? 
FDA recommends that you carefully consider the time line for the development of your 
product and your commitment to pursuing FDA approval when deciding whether to submit a 
modular PMA.  FDA may refuse to accept a PMA shell proposal if timing is inappropriate.  
For example, if you are within 6 months or less of submitting the final PMA module, FDA 
believes PMA modular review may not be appropriate.  Submitting a PMA shell proposal 
within 6 months or less of submitting the final module does not allow sufficient time for 
FDA to complete its review of all the modules before receiving the final module.   
 
If the clinical trial is lengthy or the product development time line is long, you should 
carefully consider your schedule for submitting PMA modules when developing the PMA 
shell.  Premature submission of PMA modules could result in changes that require re-
evaluation of closed PMA modules. 
 
3.  What is an appropriate length of time between submission of modules?  
You should provide the approximate timing of the submission of each PMA module in the 
PMA shell to FDA.   It is FDAs intent that applicants who choose to participate in the PMA 
Modular Review Program would submit modules at intervals that will allow the agency 
enough time to review the module, provide feedback, and close out the module prior to the 
arrival of the next module.  The one exception is the manufacturing module, which may be 
submitted without regard to the timing of submission of other module(s).  In CDRH, the 
Office of Compliance is the primary reviewer of this module, while in CBER, both the Office 
of Biologics Quality and the product office review10 the manufacturing module.  
 
4.  What should I include with each module? 
You should include the following in each PMA module:  
 
  cover letter; 
  table of contents; 
  executive summary of the testing and results included in the module; and 
  bibliography.   
                                                 
10 Please discuss with the appropriate regulatory project management branch in CBER. 
  13  Contains Nonbinding Recommendations 
 
 
In addition, you should submit complete information for each module, i.e., all testing should 
be finished and the results provided, which will enable FDA to review the data and make a 
decision.  If the PMA module is incomplete, FDA may refuse to accept the PMA module for 
review. 
 
5.  What happens to the outstanding modules when I submit my final PMA module? 
You should address any outstanding deficiencies from previously submitted modules when 
you submit the final PMA module.  Once you submit the final PMA module, FDA considers 
the PMA shell and its modules closed and makes its filing decision.  
 
6.  When do I have to pay the user fee for a Modular PMA?  
The fee for a modular PMA is due upon submission of the first module.11  If FDA receives 
the first module prior to payment, we will place the file on hold until we receive payment12 
and notify the applicant of this action by facsimile.  The 90 day review clock for the first 
module starts on the date that FDAs Office of Financial Management notifies CDRH or 
CBER that payment has been received. 
 
                                                 
11 Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and 
Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and 
Fees for Combination Products can be found at: 
www.fda.gov/cdrh/mdufma/guidance/1201.html 
12 See section 515(c)(3)(A) of the act. 
  14