Guidance for Industry and FDA Staff 

User Fees and Refunds for 

Premarket Approval Applications

Document Issued on: November 24, 2003

For questions regarding this document, contact Thinh Nguyen (CDRH) at 240-276-4010 or 

by email at thinh.nguyen@fda.hhs.gov or Sayah Nedjar (CBER) at (301) 827-3524 or by email at 

nedjar@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 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. 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/1224.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 via your fax machine, 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 

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Follow the remaining voice prompts to complete your request. 
Contains Nonbinding Recommendations

Table of Contents

I. Purpose............................................................................................................................... 1

II. Background ................................................................................................................... 1

III. What Types of Original PMA Applications Are Subject to User Fees?....................... 2

A. Traditional PMAs............................................................................................................. 2

B. Modular PMAs................................................................................................................. 2

C. Licensing Agreement PMAs............................................................................................ 2

IV. What Types of PMA Supplements Are Subject to User Fees?..................................... 3

A. Panel-Track PMA Supplements....................................................................................... 3

B. 180-Day Supplements and Real-Time Supplements ....................................................... 4

V. Are There Any Exceptions to the Above Fees for Original PMAs or PMA 

Supplements? ............................................................................................................................ 4

VI. What Types of PMA Supplements or Submissions Are Not Subject to User Fees? .... 4

A. Special PMA Supplements – Changes Being Affected and 30 Day Notices/135 Day 

Supplements........................................................................................................................... 5

B. Manufacturing Site Changes............................................................................................ 5

C. Private Label Distributor.................................................................................................. 5

D. Trade Name Change......................................................................................................... 6

E. Post Approval Protocol.................................................................................................... 6

F. Modifying the Post Approval Protocol............................................................................ 6

G. Post Approval Study Results........................................................................................... 6

VII. Will FDA Refund User Fees When an Applicant Submits a PMA for a Product That 

We Determine is Not a Device?................................................................................................ 6

VIII. Will FDA Refund User Fees When We Refuse to File an Application? ...................... 7

IX. Will FDA Refund User Fees When an Applicant Withdraws a PMA Application? .... 7

X. What Refunds Are There for Modular PMAs? ............................................................. 8

XI. What Refunds Are There for Licensing Agreement PMAs? ........................................ 9

XII. How Does an Applicant Request a Refund? ................................................................. 9

XIII. Is There a Deadline to Request a Refund? .................................................................... 9

XIV. Are FDA’s Decisions on Refunds Reviewable by a Court? ....................................... 10

Appendix I. User Fees for Original PMAs ............................................................................ 11

Appendix II. User Fees for PMA Supplements or Submissions............................................ 12
Contains Nonbinding Recommendations

1

Guidance for Industry and FDA Staff

User Fees and Refunds for Premarket 

Approval Applications 

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: 

• outline the various types of premarket approval (PMA) applications, 

• discuss the fees associated with each type, and 

• identify industry or FDA actions on submissions that may result in refunds of fees 

that have been paid.

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

The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (P.L. 107-

250) amends the Federal Food, Drug, and Cosmetic Act (the act) to provide FDA new 

responsibilities and resources. One significant provision of MDUFMA, Section 7381, 

requires FDA to collect user fees for certain premarket applications received on or after 

October 1, 2002. The new law establishes user fee rates that vary depending on the type 

of application submitted. There are, however, several types of PMA submissions that are 

not subject to user fees because they are expressly excluded from fees under MDUFMA 

 

1

 All references to sections 737 and 738 in this guidance refer to sections 737 and 738 of 

MDUFMA.
Contains Nonbinding Recommendations

2

(e.g., 30 day Notices/135 day Supplement, Special PMA Supplement – Changes Being 

Affected).

III. What Types of Original PMA Applications Are Subject to 

User Fees?

In accordance with section 738(a)(1)(A), all types of original PMA applications 

submitted on or after October 1, 2002 are subject to user fees, as discussed below. The 

types of original PMA applications are:

• Traditional PMAs

• Modular PMAs

• Licensing Agreement PMAs.

A. Traditional PMAs

A traditional PMA is one in which all elements required under 21 CFR 814.20 are 

submitted at the same time in a single application. FDA will assess the user fee in 

effect at the time of the submission (e.g., $206,811 in FY 04).

2

 

B. Modular PMAs

As discussed in the guidance document entitled, “Premarket Approval Application 

Modular Review,” a modular PMA is a compilation of sections or “modules” that are 

submitted at different times that together become a complete application. FDA uses 

the term module to identify a set of elements, tests, information, etc., that addresses a 

selected aspect of the device application, such as manufacturing or animal testing. 

This approach allows an applicant to submit discrete sections of the PMA to FDA for 

review soon after completing the testing and analysis. 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.

3

 

For a modular PMA with a module submitted before October 1, 2002, FDA will not 

assess a fee. For a modular PMA with the first module submitted on or after October 

1, 2002, FDA will assess the full fee for an original PMA.

4

 This fee is due when the 

applicant submits the first module.5

C. Licensing Agreement PMAs

 

2

 See 68 FR 45246, August 1, 2003; Section 738(a)(1)(A)(i).

3

 For more information on the modular PMA process, see the guidance entitled, 

“Premarket Approval Application Modular Review” on the web at: [Insert website when 

posted].

4

 See Section 738(a)(1)(A).

5

 See Section 738(a)(1)(C).
Contains Nonbinding Recommendations

3

A PMA holder (hereafter referred to as a licensor) may enter into a licensing

agreement with another party (hereafter referred to as a licensee) to provide that party 

with permission to reference the data in its PMA. The licensee, in submitting the 

licensing agreement PMA to FDA, requests FDA to approve its own device, by 

referencing the information that was used as a basis for approval of the licensor’s 

device. Upon receiving FDA’s approval, the licensee assumes all the responsibilities 

of a PMA holder, including the manufacture and distribution of a device that is 

identical to the licensor’s. In addition, following approval of the licensing agreement, 

licensees may choose to make changes to their product. As for all PMA holders, such 

changes may require the submission of a PMA supplement. 

Under the MDUFMA user fee provisions, there is no distinction with respect to fee 

amounts for PMAs based on licensing agreements and those based on original data.

6

 

Therefore, PMAs based on licensing agreements are subject to the same fees as 

submissions based on original data. Similarly, certain PMA supplements submitted 

to a licensee’s PMA would be subject to a user fee just as such supplements to a 

licensor’s PMA would be subject to fees.

Appendix I summarizes the user fees associated with the different types of original 

PMAs.

IV. What Types of PMA Supplements Are Subject to User 

Fees?

In accordance with MDUFMA, three types of PMA supplements are subject to user fees, 

as discussed below. 7 The PMA supplements subject to user fees are:

• panel-track supplements

• 180-day supplements

• real-time supplements.8 

A. Panel-Track PMA Supplements

Similar to a traditional PMA, a panel-track PMA supplement submitted on or after 

October 1, 2002, will be assessed the user fee in effect at the time of submission (e.g., 

$206,811 for FY 04).

9

 

 

6

 See Sections 737 and 738(a)(1)(A).

7

 See Sections 738(a)(1)(A)(iii), (iv), and (v). 

8

 For definitions of panel-track, 180-day, and real-time supplements, see the guidance 

entitled, “Assessing User Fees; PMA Supplements Definitions, Modular PMA Fees, BLA 

and Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, 

and Fees for Combination Products: at: www.fda.gov/cdrh/mdufma/guidance/1201.html. 

(Hereafter this guidance will be referred to as the Assessing User Fee guidance.)

9

 See Section 738(a)(1)(A)(iii) and 68 FR 45246, August 1, 2003.
Contains Nonbinding Recommendations

4

B. 180-Day Supplements and Real-Time Supplements

Under MDUFMA, 180-day supplements and real-time supplements submitted on or 

after October 1, 2002, will be assessed the user fee in effect at the time of the 

submission (e.g., $44,464 (21.5% of an original PMA fee) and $14,890 (7.2% of an 

original PMA fee), respectively, for FY 04).

10

 

V. Are There Any Exceptions to the Above Fees for Original 

PMAs or PMA Supplements?

Yes. Under MDUFMA, any original PMA or PMA supplement that is intended 

solely for a pediatric population is exempt from user fees.11 If, however, after 

approval of the original PMA, the PMA holder proposes conditions of use for an

adult population, the supplement is subject to the fee in effect at the time of 

submission. 12

In addition, MDUFMA provides an exception for PMAs or PMA supplements 

submitted by a state or federal government entity “unless the device involved is to be 

distributed commercially.”13 While permitted by statute, FDA does not anticipate 

that many PMAs will be submitted under these circumstances.

VI. What Types of PMA Supplements or Submissions Are Not 

Subject to User Fees?

There are other types of supplemental applications, defined in the regulation (21 CFR 

814.39) and discussed below, that are not subject to user fees. Because the changes 

submitted in the supplements identified below are not reviewed jointly with the 

applicant, FDA does believe that these supplements fall within MDUFMA’s 

definition of a real-time supplement.

14 Therefore, the submissions listed below are 

not subject to user fees. 

 

10 See Sections 738(a)(1)(A)(iv) and (v).

11 See Section 738(a)(1)(B)(v)(I). In addition, there may be situa tions, which upon 

review of the device and its intended population, FDA determines that the application 

qualified for the pediatric exemption although the applicant did not request a waiver. In 

such a case, FDA intends to refund the user fee.

12 See Section 738(a)(1)(B)(v)(II).

13 See Section 738(a)(1)(B)(iii).

14 According to Section 737(4)(D), a real-time supplement “requests a minor change to 

the device, such as a minor change to the design of the device, software, manufacturing, 

sterilization, or labeling, and for which the applicant has requested and the agency has 

granted a meeting or similar forum to jointly review and determine the status of the 

supplement.”
Contains Nonbinding Recommendations

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• Special PMA Supplements – Changes Being Affected and 30 day 

Notices/135 day Supplements

• Manufacturing site changes, including Express PMA Supplements

• Private label distributor

• Trade name change

• Post approval protocol

• Modifying the post approval protocol

• Post approval study results.

These types of submissions are briefly described in the following sections. You should 

refer to the regulation cited, however, for complete descriptions of the types of changes 

that are appropriate for these types of submissions.

A. Special PMA Supplements – Changes Being Affected and 30 Day Notices/135 

Day Supplements

In a Special PMA Supplement – Changes Being Affected, the PMA holder may effect 

any change “that enhances the safety of the device or the safety in the use of the 

device” such as: a) “labeling change s that add or strengthen a contraindication, 

warning, precaution, or information about an adverse reaction, or b) “changes in

quality controls or manufacturing process that add a new specification or test method, 

or otherwise provide additional assurance of the purity, identify, strength, or 

reliability of a device” prior to the receipt of a written FDA order approving the 

supplement. 

In addition, “modifications to the manufacturing procedures or methods of 

manufacture that affect the safety and effectiveness of a device” may be submitted 

under the 30 Day Notice/135 Day Supplement provision of the PMA regulation. 15

B. Manufacturing Site Changes

A manufacturing site change supplement is one in which the applicant is requesting to 

move the manufacturing site to another location or to add an additional site.

16

 

C. Private Label Distributor 

In a private label distributor supplement, a PMA holder enters into an agreement with 

another party to permit that party to distribute the approved device under its own 

 

15 See 21 CFR 814.39 (d) (Special PMA Supplement - Changes Being Affected) and (f) 

(30 day notices/135 day supplements).

16 See 21 CFR 814.39(a)(3).
Contains Nonbinding Recommendations

6

private label. The holder of the original PMA must submit a PMA supplement 

requesting FDA approval of the agreement.

17

 

D. Trade Name Change

In this type of supplement, the PMA holder requests a change in the trade name of its 

approved device.

18

 

E. Post Approval Protocol

FDA may require a PMA applicant, as a condition of approval of the original PMA, 

to conduct a post approval study to look at specific safety concerns or to assess the 

long-term safety and effectiveness of the device.

19 As such, a PMA holder must 

request approval of the post approval study protocol, as required by the Conditions of 

Approval for the PMA. 

F. Modifying the Post Approval Protocol

During the course of the post approval study, the PMA holder may wish to request 

approval for a modification of the post approval protocol (e.g., to reduce the number 

of subjects in the study due to slow enrollment). 

G. Post Approval Study Results

Upon completion of a post approval study, the PMA holder may need to update the 

device labeling to reflect the results of the study. These results are submitted for 

agency review as a PMA supplement.

20

Appendix II summarizes the user fees associated with the different types of PMA 

supplements and submissions.

VII. Will FDA Refund User Fees When an Applicant Submits 

a PMA for a Product That We Determine is Not a Device?

Prior to a PMA filing review, FDA determines whether the product is a device as 

defined in section 201(h) of the act. If FDA determines that the product is not a 

device, the agency notifies the applicant in writing of its decision (i.e, a PMA 

application is not required). In this situation, FDA plans to refund the full fee to the 

applicant. 

 

17 See 21 CFR 814.39(a).

18 See 21 CFR 814.39(a).

19 See 21 CFR 814.82(a)(2). 

20 See 21 CFR 814.39 (a).
Contains Nonbinding Recommendations

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VIII.Will FDA Refund User Fees When We Refuse to File an 

Application?

If a traditional PMA or panel-track supplement is refused for filing, FDA will refund 

75% of the fee paid.21 When the applicant resubmits the PMA with the additional 

information necessary to file the PMA, however, FDA intends to assess the full fee.

IX. Will FDA Refund User Fees When an Applicant 

Withdraws a PMA Application?

Generally, the amount of the fee that FDA may refund for a PMA depends on the 

type of application (i.e., original or supplement) and when the applicant submits the 

request to withdraw the application, as discussed below.

A. Refunds when an applicant requests withdrawal of a traditional PMA or 

panel-track supplement before filing 

If an applicant requests withdrawal of a traditional PMA or panel-track supplement 

before FDA makes the filing decision, we will refund 75% of the fee.

22

B. Refunds when an applicant requests a refund after FDA has filed the 

traditional PMA or panel-track supplement, but before FDA takes a first action

FDA has the discretion to refund fees if an applicant withdraws its PMA or paneltrack supplement after FDA has filed it, but before we have taken a first action.

23

First actions may be the issuance of a major deficiency letter, a not approvable letter, 

an approvable letter, an approval order, or a withdrawal letter.24 FDA will base any 

refund after filing, but before the first action is taken, on the “level of effort already 

expended on the review,” as required by MDUFMA. 25 FDA believes that, in most 

instances, our level of effort can be appropriately assessed by the number of days that 

an application was under review. This approach permits FDA to calculate and 

process refunds much more efficiently than if we were to attempt to estimate factors

on a case-by-case basis, such as the amount of time each member of the review team 

spent on the review and the significance and complexity of the scientific, medical, 

technical, and regulatory issues examined during the course of the review. For these 

reasons, FDA generally intends to make refunds by referring to the following 

guidelines for traditionalPMAs and panel-track supplements:

 

21 See Section 738(a)(1)(D)(i). 

22 See Section 738(a)(1)(D)(ii). 

23 See Section 738(a)(1)(D)(iii). 

24 See the guidance entitled, “FDA and Industry Actions of Premarket Approval 

Applications (PMAs): Effect on FDA Review Clock and Performance Assessment” at 

www.fda.gov/cdrh/mdufma/guidance/1218.html.

25 See Section 738(a)(1)(D)(iii).
Contains Nonbinding Recommendations

8

• when withdrawn between the date of the filing decision and day 90, a 50% 

refund of the fee

• when withdrawn between day 91 and day 135, a 25% refund of the fee

• when withdrawn after day 135, no refund.

FDA recognizes, however, that when there are unusual circumstances, the number of 

days that an application was under review may not provide a complete picture. Under 

such unusual circumstances, FDA may take additional factors other than the number 

of days under review into consideration.

C. Refunds after FDA has taken a first action on a traditional PMA or paneltrack supplement

In accordance with MDUFMA, if an applicant requests withdrawal of a traditional

PMA or panel-track supplement at any time after FDA has taken its first action, 

regardless of when the action is taken, FDA will not refund any portion of the fee.26

D. Refunds for 180-day and Real-Time Supplements

For 180-day and real-time supplements, FDA considers the application filed upon 

receipt. The fees for these types of supplements are significantly less than those 

required for original PMAs, and generally, the reviews are conducted over a shorter 

period of time. Therefore, in accordance with FDA’s authority under section 

738(a)(1)(D)(iii) of MDUFMA to base the refund on the amount of effort expended, 

FDA does not intend to refund any amount of the fee for these types of supplements 

after they have been filed. 

X. What Refunds Are There for Modular PMAs?

For a modular PMA, the applicant is required by statute to pay a full fee for an 

original PMA when the “first portion” of the application is submitted.

27

 The filing 

decision for a modular PMA, however, is not made until the last module is 

submitted.28 If FDA does not file the modular PMA application, the agency will

refund 75% of the fee in accordance with MDUFMA.

29

 

 

26 Section 738(a)(1)(D)(iii) does not provide FDA with authority to refund any portion of 

fees after the agency has taken a first action on an application. 

27 See Section 738(a)(1)(C). 

28 See “Premarket Approval Application Modular Review” for a complete discussion of 

the modular PMA review program at [Insert website when posted]. As detailed in this 

guidance, the last module generally is the clinical module, and FDA bases its filing 

decision on this last module.

29 See Section 738(a)(1)(D)(i).
Contains Nonbinding Recommendations

9

In addition, applicants who withdraw their modular PMAs can expect refunds in the 

same manner as other original PMAs:

• when withdrawn prior to FDA’s filing decision, a 75% refund of the fee30

• when withdrawn after the filing decision but before a first action, FDA will 

follow the guidelines presented in Section IX. B.

• when withdrawn after first action, no refund.31

XI. What Refunds Are There for Licensing Agreement 

PMAs?

Licensing Agreement PMAs are considered filed upon receipt. In those cases where 

an applicant submitted a licensing agreement PMA that included new manufacturing 

procedures and/or a new manufacturing facility and requests withdrawal before FDA 

takes its first action, we intend to apply the refund policy discussed above (see 

Section IX. B.) for traditional PMAs. If, however, the licensing agreement PMA 

incorporates by authorized reference all the information required by 21 CFR 814.20, 

including the same manufacturing procedures and facilities, and an applicant requests 

withdrawal before first action (generally an approval order), FDA plans to refund the 

full fee. 

XII. How Does an Applicant Request a Refund?

FDA considers your written request to withdraw a PMA or panel-track supplement to 

be an automatic request for a refund. Withdrawal requests should be submitted to:32

PMA Document Mail Center, HFZ-401

Office of Device Evaluation

Center for Devices and Radiological Health

9200 Corporate Blvd.

Rockville, MD 20850

XIII.Is There a Deadline to Request a Refund?

Yes. To request a refund, an applicant must submit the request to FDA no later than 

180 days after the fee was due.

33

 

30 See Section 738(a)(1)(D)(ii).

31 See Section 738(a)(1)(D)(iii).

32 See Section 738(j).

33 See Section 738(j).
Contains Nonbinding Recommendations

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XIV. Are FDA’s Decisions on Refunds Reviewable by a Court?

No. Although you may request that FDA reconsider its decision about a refund,34 you 

may not appeal FDA’s decision to a court. MDUFMA provides that any refund 

decision that FDA makes with respect to a PMA is not reviewable.35

 

34 See the guidance entitled, “Resolving Disputes that Affect the Payment or Refund of 

Medical Device User Fees” at [Insert website when available].

35 See Section 738(a)(1)(D)(iii).
Contains Nonbinding Recommendations

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Appendix I. User Fees for Original PMAs

Types of Original PMAs Fee Due at the Time of SubmissionA

Traditional

Submitted on or after Oct. 1, 2002 Fee in effect at the time of submission

Modular

First module submitted before Oct. 1, 2002 $ 0.0

Modular

First module submitted on or after Oct. 1, 2002 Fee in effect at the time of submission

Licensing Agreement 

Submitted on or after Oct. 1, 2002 Fee in effect at the time of submission

A

In accordance with section 738(c) of MDUFMA, FDA will adjust the fees each year to 

account for inflation, changes in workload, and other factors. FDA will announce the 

new fees for the next fiscal year in a Federal Register notice no later than 60 days before 

the start of that fiscal year, and post these fees on our website at 

www.fda.gov/cdrh/mdufma/index.html.
Contains Nonbinding Recommendations

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Appendix II. User Fees for PMA Supplements or Submissions

Types of PMA Supplements or 

Submissions Fee Due at the Time of SubmissionA

Panel-Track Fee in effect at time of submission

180-Day Fee in effect at time of submission

Real-Time Fee in effect at time of submission

Special PMA Supplement – Changes Being 

Affected $ 0.0

30 Day Notice/135 Day Supplement $ 0.0

Manufacturing site change, including Express 

PMA Supplement $ 0.0

Private Label Distributor $ 0.0

Trade Name Change $ 0.0

Submission of post approval protocol as a 

Condition of Approval for the original PMA $ 0.0

Submission of a request to modify post 

approval protocol $ 0.0

Submission of the results of post approval 

study to change the device labeling $ 0.0

A

In accordance with section 738(c) of MDUFMA, FDA will adjust the fees each year to 

account for inflation, changes in workload, and other factors. FDA will announce the 

new fees for the next fiscal year in a Federal Register notice no later than 60 days before 

the start of that fiscal year. FDA will also post these fees on our website at 

www.fda.gov/cdrh/mdufma/index.html.