Draft Guidance for Industry and FDA 

Staff 

User Fees and Refunds for 

Premarket Approval Applications 

DRAFT GUIDANCE 

This guidance document is being distributed for comment purposes only. 

Document issued on: March 16, 2009

Comments and suggestions regarding this draft document should be submitted within 30 days of 

publication in the Federal Register of the notice announcing the availability of the draft guidance. 

Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Alternatively, electronic 

comments may be submitted to http://www.regulations.gov. All comments should be identified 

with the docket number listed in the notice of availability that publishes in the Federal Register. 

For questions regarding the interpretation of this document in the review of PMAs, please 

contact the PMA Staff at (240) 276-4040. For questions regarding the interpretation of this 

document in the review of PMA devices regulated by CBER, please contact the Office of 

Communication, Training and Manufacturers Assistance, Division of Manufacturers Assistance 

and Training at 800-835-4709 or 301-827-1800. 

 

When final, this document will supersede “User Fees and Refunds for 

Premarket Approval Applications” dated November 24, 2003.

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 

Draft - Not for Implementation 

Preface 

Additional Copies 

Additional copies are available from Center for Devices and Radiological Health (CDRH) 

through the Internet at http://www.fda.gov/cdrh/ode/guidance/1681.pdf. You may also send an 

e-mail request to dsmica@fda.hhs.gov to receive an electronic copy of the guidance or send a fax 

request to 240-276-3151 to receive a hard copy. Please use the document number (1681) to 

identify the guidance you are requesting. 

Additional copies of this guidance document are also available from the Center for Biologics 

Evaluation and Research (CBER), Office of Communication, Training and Manufacturers 

Assistance (HFM-40), 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448, or by 

calling 1-800-835-4709 or 301-827-1800, or from the Internet at 

http://www.fda.gov/cber/guidelines.htm. 
Contains Nonbinding Recommendations 

Draft – Not for Implementation 

Table of Contents 

I. Introduction ............................................................................................................................. 1 

II. Types of PMA Applications Subject to User Fees.................................................................. 2 

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

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

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

D. Panel-Track Supplements................................................................................................3 

E. 180-Day Supplements......................................................................................................3 

F. Real-Time Supplements ..................................................................................................3 

G. 30-Day Notices................................................................................................................4 

H. Periodic Reports ..............................................................................................................4 

III. Exception to User Fees............................................................................................................ 5 

IV. User Fee Refunds .................................................................................................................... 5 

A. FDA refuses to file a Traditional PMA or Panel-Track Supplement ..............................5 

B. Applicant requests withdrawal of a Traditional PMA or Panel-Track Supplement 

before filing .....................................................................................................................5 

C. Applicant requests withdrawal of a filed Traditional PMA or Panel-Track Supplement, 

but FDA has not taken a first action................................................................................5 

D. FDA has taken a first action on a Traditional PMA or Panel-Track Supplement...........6 

E. Modular PMAs................................................................................................................7 

F. Licensing Agreement PMAs ...........................................................................................7 

G. 180-Day Supplements......................................................................................................8 

H. Real-Time Supplements ..................................................................................................8 

I. 30-Day Notices................................................................................................................8 

J. Periodic Reports ..............................................................................................................8 

V. How to Request a User Fee Refund ........................................................................................ 8 
Contains Nonbinding Recommendations 

Draft – Not for Implementation 

Draft Guidance for Industry and FDA Staff 

User Fees and Refunds for Premarket 

Approval Applications 

This draft guidance document 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 document. If you cannot identify the appropriate FDA staff, call the appropriate 

number listed on the title page of this guidance document. 

I. Introduction 

The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Pub. 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 738,1

 requires FDA to collect 

user fees for certain premarket approval applications (PMAs) received on or after October 1, 

2002. MDUFMA established user fee rates that vary depending on the type of PMA submitted. 

The Food and Drug Administration Amendments Act of 2007 (FDAAA) (Pub. L. 110-85) now 

requires user fees for 30-day notices and periodic reports. FDAAA also modifies the refund 

provision for modular PMAs. 

The purpose of this draft guidance document is to identify: (1) the types of PMAs subject to user 

fees; (2) the types of PMAs that are not subject to user fees because they are expressly excluded 

from fees under the act; and (3) the actions that may result in refunds of user fees that have been 

paid. The primary difference between this version and the 2003 version is the addition of user 

fee and user fee refund information for 30-day notices and periodic reports, as well as the 

modified user fee refund provisions for modular PMAs. Once final, this document will 

supersede the 2003 guidance document of the same title. 

FDA's guidance documents, including this guidance document, do not establish legally 

enforceable responsibilities. Instead, guidance documents 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 guidance documents means that 

something is suggested or recommended, but not required. 

 

1

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

Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 379i and 21 U.S.C. 379j, respectively). 

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II. Types of PMA Applications Subject to User Fees 

In accordance with the act, as modified by FDAAA, the following types of PMA applications2

are subject to user fees: 

• Traditional PMAs;

• Modular PMAs; 

• Licensing Agreement PMAs; 

• Panel-Track Supplements; 

• 180-day Supplements; 

• Real-time Supplements; 

• 30-day Notices; and 

• Periodic Reports. 

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. For traditional PMAs submitted on or 

after October 1, 2002, FDA will assess the user fee in effect at the time of the submission 

(e.g., $185,000 in fiscal year 2008 (FY 08)).3

B. Modular PMAs

A modular PMA is a compilation of sections or “modules” that are submitted at different 

times that together become a complete application.4 For modular PMAs submitted on or 

after October 1, 2002, FDA will assess the user fee in effect for a traditional PMA at the 

time of submission of the first module.5

C. Licensing Agreement PMAs 

A licensing agreement PMA involves a PMA applicant (hereafter referred to as a licensor) 

entering 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, after 

submitting the licensing agreement PMA to FDA, may request FDA to approve its own 

device, by referencing all 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 applicant, including the manufacture and distribution of a device 

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

2

 Section 737(1) of the act includes product development protocols within the definition of premarket applications 

subject to user fees. 

3

 See 72 FR 58099, October 12, 2007; section 738(a)(2)(A)(i) of the act. 

4

 For more information on the modular PMA process, see the guidance document entitled, “Premarket Approval 

Application Modular Review” at http://www.fda.gov/cdrh/mdufma/guidance/835.pdf. 5

 See section 738(a)(2)(C) of the act. 

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

applicants, such changes may require the submission of a PMA supplement. 

Under the act’s 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, 

traditional PMAs and PMA supplements 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 user fees. 

D. Panel-Track Supplements 

Section 737(4)(B) of the act defines “panel-track supplement” as “supplement to an 

approved premarket application or premarket report under section 515 that requests a 

significant change in design or performance of the device, or a new indication for use of the 

device, and for which substantial clinical data are necessary to provide a reasonable 

assurance of safety and effectiveness.”7

 

For panel-track supplements submitted on or after October 1, 2002, FDA will assess the 

user fee in effect at the time of submission (e.g., $138,750 for FY 08).8 

E. 180-Day Supplements 

Section 737(4)(C) of the act defines “180-day supplement” as “a supplement to an 

approved premarket application or premarket report under section 515 that is not a paneltrack supplement and requests a significant change in components, materials, design, 

specification, software, color additives, or labeling.”9

For 180-day supplements submitted on or after October 1, 2002, FDA will assess the user 

fee in effect at the time of the submission (e.g., $27,750 for FY 08).10 

F. Real-Time Supplements 

Section 737(4)(D) of the act defines “real time supplement” as “a supplement to an 

approved premarket application or premarket report under section 515 that requests a minor 

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

6

 See section 738(a)(2)(A) of the act. 

7

 For more information on panel-track supplements, see the guidance document entitled, “Modifications to Devices 

Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process” at 

http://www.fda.gov/cdrh/ode/guidance/1584.pdf. 8

 See sections 738(a)(2)(A)(iii) and 72 FR 58099, October 12, 2007. From October 1, 2002 through September 30, 

2007, the user fee for panel-track supplements was the same as for a traditional fee. FDAAA has reduced the user 

fee for panel-track supplements. 

9

 For more information on 180-day supplements, see the guidance document entitled, “Modifications to Devices 

Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process” at 

http://www.fda.gov/cdrh/ode/guidance/1584.pdf. 10 See section 738(a)(2)(A)(iv) of the act. 

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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.”11 

For real-time supplements submitted on or after October 1, 2002, FDA will assess the user 

fee in effect at the time of the submission (e.g., $12,950 for FY 08).12 

G. 30-Day Notices 

Section 737(5) of the act defines “30-day notice” as “a notice under section 515(d)(6) that 

is limited to a request to make modifications to manufacturing procedures or methods of 

manufacture affecting the safety and effectiveness of the device.”13

For 30-day notices received on or after October 1, 2007, FDA will assess the user fee in 

effect at the time of the submission (e.g., $2,960 for FY 08).14 If a 30-day notice is 

converted to a 135-day supplement, the user fee paid for the 30-day notice will not be 

refunded. 

H. Periodic Reports15

Under section 212 of FDAAA, PMA applicants are subject to an “annual fee for periodic 

reporting concerning a class III device.” FDA will assess the user fee in effect at the time 

of the submission of the periodic report (e.g., $6,475 for FY 08).16 17 Devices with 

approved PMAs that have been subsequently reclassified into class II are not subject to 

PMA regulations and, therefore, will not be assessed a periodic reporting user fee. 

Although FDA has allowed some applicants to submit bundled periodic reports, the annual 

fee is required for each PMA identified in the periodic report. 

11 For more information on real-time supplements, see the guidance document entitled, “Real-Time Premarket 

Approval Application (PMA) Supplements” at http://www.fda.gov/cdrh/ode/guidance/673.pdf. In addition, see the 

guidance document entitled, “Modifications to Devices Subject to Premarket Approval (PMA) - The PMA 

Supplement Decision-Making Process” at http://www.fda.gov/cdrh/ode/guidance/1584.pdf. 12 See section 738(a)(2)(A)(v) of the act. 13 For more information on 30-day notices, see the guidance document entitled, “30-Day Notices and 135-Day PMA 

Supplements for Manufacturing Method or Process Changes” at http://www.fda.gov/cdrh/modact/daypmasp.pdf. In 

addition, see the guidance document entitled, “Modifications to Devices Subject to Premarket Approval (PMA) - 

The PMA Supplement Decision-Making Process” at http://www.fda.gov/cdrh/ode/guidance/1584.pdf. 14 See section 738(a)(2)(A)(vi) of the act. 

15 In accordance with 21 CFR 814.82(a)(7), FDA may require, as a condition of approval, submission to FDA at 

intervals specified in the approval order of periodic reports containing the information required by 21 CFR 

814.84(b). In most cases, after the PMA is approved, the PMA applicant is required to submit reports to FDA 

annually unless a different time frame is specified in the approval order. Accordingly, periodic reports are typically 

referred to by FDA and industry as “annual reports.” Periodic reports are separate from the postapproval study 

reports, which are discussed in the guidance document entitled, “Procedures for Handling Post-Approval Studies 

Imposed by PMA Order” at http://www.fda.gov/cdrh/osb/guidance/1561.pdf. 16 See section 738(a)(2)(A)(x) of the act. 17 PMAs are not subject to the periodic reporting user fee until the first fiscal year following approval of the original 

PMA. This corresponds to when the first periodic report would be due. 

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III. Exception to User Fees 

Under the act’s user fee provisions, any PMA that is intended solely for a pediatric population is 

exempt from user fees.18 There may be situations where, 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 would refund the user fee. 

However, if after approval of a traditional or modular PMA for pediatric use, the PMA applicant 

proposes conditions of use for an adult population, the supplement is subject to the full user fee 

in effect at the time of submission.19 

The act also allows an exemption from user fees for a PMA submitted by a state or federal 

government entity “unless the device involved is to be distributed commercially.”20 While 

permitted by statute, FDA does not anticipate that many PMAs will be submitted under these 

circumstances. 

IV. User Fee Refunds 

User fee refunds are handled as described below. 21

A. FDA refuses to file a Traditional PMA or Panel-Track Supplement 

If FDA issues a non-filing letter for a traditional PMA or panel-track supplement, FDA will 

refund 75% of the fee paid.22 When an applicant amends a PMA to respond to a non-filing 

letter, FDA will require the full user fee in effect at the time of submission. 

B. 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 user fee.23 

C. Applicant requests withdrawal of a filed Traditional PMA or Panel-Track 

Supplement, but FDA has not taken a first action 

FDA has the discretion to refund fees if an applicant withdraws its PMA or panel-track 

supplement after FDA has filed it, but before we have taken a first action.24 First actions 

18 See section 738(a)(2)(B)(v)(I) of the act. 

19 See section 738(a)(2)(B)(v)(II) of the act. 

20 See section 738(a)(2)(B)(iii) of the act. 

21 See section 738(a)(2)(D)(iii) of the act. 

22 See section 738(a)(2)(D)(i) of the act. 23 See section 738(a)(2)(D)(ii) of the act. 

24 See section 738(a)(2)(D)(iii) of the act. 

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

letter, an approval order, or a withdrawal letter.25 

FDA will base any refund it issues after a filing, but before a first action is taken, on the 

“level of effort already expended on the review,” as required by the act.26 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 intends to make refunds by referring to the following guidelines for 

traditional PMAs and panel-track supplements: 

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

of the user fee; 

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

• when withdrawn after day 135, no user fee 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. 

Although you may request that FDA reconsider its decision about a user fee refund, “[t]he 

Secretary has sole discretion to refund a fee or portion of the fee” for an application 

withdrawn after filing but before first action.27 A determination by the Secretary 

concerning a refund is not reviewable.28

D. FDA has taken a first action on a Traditional PMA or Panel-Track Supplement 

In accordance with the act, 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 user fee.29 

25 See the guidance document entitled, “FDA and Industry Actions of Premarket Approval Applications (PMAs): 

Effect on FDA Review Clock and Performance Assessment” at 

http://www.fda.gov/cdrh/mdufma/guidance/1218.pdf. 26 See section 738(a)(2)(D)(iii) of the act. 

27 Section 738(a)(2)(D)(vi) of the act. 

28 Id. See the guidance document entitled, “Resolution of Disputes Concerning Payment or Refund of Medical 

Device User Fees Under MDUFMA” at http://www.fda.gov/cdrh/mdufma/guidance/1303.pdf. 29 Section 738(a)(2)(D)(iii) of the act does not provide FDA with authority to refund any portion of fees after the 

agency has taken a first action on an application. 

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E. Modular PMAs 

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

PMA when the first module is submitted.30 Although there is no filing review completed 

on the individual modules, actions can be taken. Module actions include an acceptance 

letter or a deficiency letter. 

Upon receipt of the last module, the modular PMA is converted to a traditional PMA 

review track. At that point, the filing review for that PMA is initiated.31 

User fee refunds for modular PMAs for which the first module was received between 

October 1, 2002 and September 30, 2007 will be handled in the following manner: 

• when withdrawn prior to FDA’s filing decision, a 75% refund of the user fee;32

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

the guidelines presented in Section IV, Part D, above; or 

• when withdrawn after the filing decision and a first action, no user fee refund.33 

User fee refunds for modular PMAs for which the first module was received on or after 

October 1, 2007 will be handled in the following manner: 

• when withdrawn prior to submission of a second module and before a first action 

on the first module, a 75% refund of the user fee;34 or 

• when withdrawn after a second or subsequent module is submitted but before any 

first action, the refund, if any, will be based on the “level of effort already 

expended on the review on the modules submitted.” For this situation, FDA 

intends to make refunds by referring to the following guidelines: 

o after a second module but before any first action, 50% refund of the user 

fee; 

o after a third module but before any first action, 25% refund of the user fee; 

or 

o after a fourth or subsequent module, no user fee refund. 

F. Licensing Agreement PMAs 

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

applicant submits a licensing agreement PMA that includes new manufacturing procedures 

and/or a new manufacturing facility and requests withdrawal before FDA takes its first 

 

30 See section 738(a)(2)(C) of the act. 

31 See the guidance document entitled, “Premarket Approval Application Modular Review” for a complete 

discussion of the modular PMA review program at http://www.fda.gov/cdrh/mdufma/guidance/835.pdf. As detailed 

in this guidance document, the last module generally is the clinical module, and FDA bases its filing decision on this 

last module. 

32 See section 738(a)(2)(D)(ii) of the act. 

33 See section 738(a)(2)(D)(iii) of the act. 

34 See section 738(a)(2)(D)(ii) of the act. 

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action, we intend to apply the refund policy discussed above (see Section IV., part D. 

above) 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 user fee. 

G. 180-Day Supplements 

For 180-day supplements, FDA considers the application filed upon receipt. The fees for 

these types of supplements are significantly less than those required for traditional PMAs, 

and, generally, the reviews are conducted over a shorter period of time. Therefore, in 

accordance with FDA’s authority under section 738(a)(2)(D)(iii) of the act, which bases the 

refund on the amount of effort expended, FDA does not intend to refund any amount of the 

user fee for this type of supplement after it has been filed. 

H. Real-Time Supplements 

For real-time supplements, FDA will follow the same user fee refund provisions as 

described above for 180-day supplements. 

I. 30-Day Notices 

For 30-day notices, FDA will follow the same user fee refund provisions as described 

above for 180-day supplements. 

J. Periodic Reports 

FDA does not intend to refund any amount of the annual fee for periodic reports. 

V. How to Request a User Fee Refund 

To request a refund, an applicant must submit a written request to the appropriate Center in FDA 

at the address below no later than 180 days after the fee was due.35

For products regulated by CDRH: 

PMA Document Mail Center, HFZ-401 

Office of Device Evaluation 

Center for Devices and Radiological Health 

9200 Corporate Blvd 

Rockville, MD 20850. 

For products regulated by CBER: 

 Document Control Center, HFM-99 

Center for Biologics Evaluation and Research 

 

35 See section 738(j) of the act. 

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Food and Drug Administration 

1401 Rockville Pike, Suite 200N 

Rockville, MD 20852-1448.