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 rega rding 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

1

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 CDRH’s 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 FDA’s 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.
Contains Nonbinding Recommendations

2

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 FDA’s 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 FDA’s 

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.)
Contains Nonbinding Recommendations

3

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 CBER’s 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 

agency’s 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.
Contains Nonbinding Recommendations

4

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.
Contains Nonbinding Recommendations

5

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.
Contains Nonbinding Recommendations

6

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,
Contains Nonbinding Recommendations

7

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 (HFZ-401)

Office of Device Evaluation

Center for Devices and Radiological Health

9200 Corporate Boulevard

Rockville, MD 20850 

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. 
Contains Nonbinding Recommendations

8

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

FDA’s 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).
Contains Nonbinding Recommendations

9

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 applicant’s 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 guidance9describes 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/nonfiling 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
Contains Nonbinding Recommendations

10

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. 
Contains Nonbinding Recommendations

11

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 submits final PMA Shell to DMC or DCC

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)

Review division sends a letter to the applicant 

accepting the shell 

Applicant submits user 

fee payment before 1st

PMA module

Applicant reaches 

agreement with FDA

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. 

Attachment I Modular PMA Flow
Contains Nonbinding Recommendations

12

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 

Module

Table of Contents for entire PMA, including all modules

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.
Contains Nonbinding Recommendations

13

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 reevaluation 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 FDA’s 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.
Contains Nonbinding Recommendations

14

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 payment 12

and notify the applicant of this action by facsimile. The 90 day review clock for the first 

module starts on the date that FDA’s 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.