Guidance for 

Industry and FDA Staff

Resolution of Disputes Concerning 

Payment or Refund of Medical Device 

User Fees 

Under MDUFMA

Document issued November 17, 2004

U.S. Department of Health and Human Services 

 Food and Drug Administration 

 Center for Biologics Evaluation and Research 

 Center for Devices and Radiological Health
Contains Nonbinding Recommendations 

NOVEMBER 17, 2004 2 

Table of Contents

Preface

The Least Burdensome Approach

Resolution of Disputes Concerning Payment or Refund of 

Medical Device User Fees Under MDUFMA

I. Background

II. Internal Review through the Supervisory Chain under 21 C.F.R. § 10.75 

III. Recommended Procedures for Resolving Disputes that Affect the 

Payment or Refund of Medical Device User Fees — 

Questions Concerning the Amount of a Fee or Refund

1. Can I negotiate or appeal the amount of a fee FDA wants me to pay or the amount of a 

refund FDA wants to pay to me? 

2. Will FDA review my application while I proceed with an appeal? 

Questions Concerning an Applicant’s Status

3. How can I appeal an FDA determination that I am not a “small business” under 

MDUFMA and must pay a full fee rather than a reduced or waived “small business” fee? 

4. How can I appeal an FDA determination that I am not eligible for a fee waiver for an 

application submitted by a government entity? 

Questions Concerning the Status of an Application

5. How can I appeal an FDA decision to “not file” my application? 

6. How can I appeal an FDA determination that I must pay a higher fee because my 

submission is not the type of application I believe it to be? 

7. How can I appeal an FDA determination that its review of my application had 

reached a particular stage when I withdrew the application? 
Contains Nonbinding Recommendations 

NOVEMBER 17, 2004 ii 

8. How can I appeal an FDA determination that a premarket application I submitted is 

not my first? 

Questions Concerning Review Mechanisms

9. How can I appeal FDA's designation of the primary review process for my 

combination product? 

10. What can I do if FDA does not review and act on my combination product 

application in a timely manner? 

Questions Concerning Intended Use

11. How can I appeal an FDA determination that I cannot "bundle" a device into a single 

application involving multiple devices? How can I appeal an FDA determination that I 

cannot "bundle" an indication for use of a device into a single application involving 

multiple indications for use for that device? 

12. How can I appeal an FDA determination that my application is not solely for a 

pediatric population? 

Questions Concerning Refunds

13. I accidentally submitted a duplicate (second) payment for my application. Can I 

obtain a refund of the extra amount I paid? 

14. I paid a fee for review of a 510(k), and FDA determined that my device is exempt 

from the requirement for a 510(k) premarket notification or I paid a fee for review of a 

510(k) or a PMA, and FDA determined that my product is not a device. Can I obtain a 

refund of the amount I paid? 

15. Are there instances where I cannot obtain a refund of any portion of a fee I have paid 

for review of a medical device application? 

16. If FDA determines I should receive a refund, how soon should I expect to receive my 

refund check? 

IV. Sources of Additional Information 

17. How can I obtain more information about a particular appeals process? 

18. How can I learn more about MDUFMA? 
Contains Nonbinding Recommendations 

NOVEMBER 17, 2004 iii 

Preface

Public Comment

Comments and suggestions may be submitted at any time for Agency consideration to — 

 Dockets Management Branch (HFA-305) 

 Food and Drug Administration 

 Room 1061 

 5630 Fishers Lane 

 Rockville, MD, 20852 

When submitting comments, please refer to the exact title of this guidance document. 

Comments may not be acted upon by the Agency until the document is next revised or 

updated. 

For questions regarding the use or interpretation of this guidance, contact — 

Sherry Lard, CBER Ombudsman 

Center for Biologics Evaluation and Research (HFM-4) 

Food and Drug Administration 

1401 Rockville Pike 

Rockville, MD 20852-1448 

Telephone: (301) 827-0379 

 – or – 

Les S. Weinstein, CDRH Ombudsman 

Center for Devices and Radiological Health (HFZ- 5) 

Food and Drug Administration, 

9200 Corporate Blvd. 

Rockville, MD 20850 

Telephone (301) 827-7991 
Contains Nonbinding Recommendations 

NOVEMBER 17, 2004 iv 

Additional Copies 

Additional copies are available from the Internet at: 

www.fda.gov/cdrh/mdufma/guidance/1303.pdf

Copies are also available from the CDRH Facts-on-Demand system. In order 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 document. Enter the document number 

(1303) followed by the pound symbol (#). Follow the remaining voice prompts to 

complete your request. 

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 the information requested in the 

guidance is not relevant to the decision-making process or that an alternative approach 

would be less burdensome, please contact us so we can consider your point of view. You 

may send your written comments to the contact person listed in the preface to this 

guidance or to the CDRH Ombudsman. Comprehensive information on CDRH’s 

Ombudsman, including ways to contact him, can be found on the Internet at — 

www.fda.gov/cdrh/resolvingdisputes/ombudsman.html
Contains Nonbinding Recommendations 

NOVEMBER 17, 2004 v 

Guidance for 

Industry and FDA Staff

Resolution of Disputes Concerning 

Payment or Refund of Medical 

Device User Fees 

Under MDUFMA
Contains Nonbinding Recommendations 

NOVEMBER 17, 2004 vi 

I. Background

This guidance provides FDA’s recommendations concerning the most timely and 

effective way to resolve disputes concerning FDA actions that affect the payment or 

refund of a user fee assessed under the Medical Device User Fee and Modernization Act 

of 2002 (MDUFMA). In some instances, alternative appeals processes may be available. 

Full information on appeals processes used by the Center for Devices and Radiological 

Health (CDRH) is provided in — 

• Medical Device Appeals and Complaints: Guidance on Dispute Resolution

(February 1998). This guidance provides general information on the dispute 

resolution processes used by CDRH, including alternatives to the approaches 

recommended by this guidance. 

• A Suggested Approach to Resolving Least Burdensome Issues (September 

2000). This guidance provides information on how to resolve questions 

concerning whether an FDA request for information is the least burdensome 

means of addressing a regulatory issue. 

• Resolving Scientific Disputes Concerning the Regulation of Medical Devices — A 

Guide to Use of the Medical Devices Dispute Resolution Panel (July 2001). FDA 

does not expect this guidance to apply to any dispute concerning a medical device 

user fee. 

These CDRH guidance documents are available at — 

www.fda.gov/cdrh/ombudsman/dispute.html

Full information on appeals processes used by the Center for Biologics Evaluation and 

Research (CBER) is provided in — 

• SOPP 8005, Major Dispute Resolution Process (February 1999) is available at — 

www.fda.gov/cber/regsopp/8005.htm

• SOPP 8404, Refusal to File Guidance for Product License Applications and 

Establishment License Applications (October 2002) is available at — 

www.fda.gov/cber/regsopp/8404.htm
Contains Nonbinding Recommendations 

NOVEMBER 17, 2004 2 

Note concerning statutory citations. Throughout this document, all statutory 

citations are to the Federal Food, Drug, and Cosmetic Act except where otherwise noted. 
Contains Nonbinding Recommendations 

NOVEMBER 17, 2004 3 

II. Internal Review through the Supervisory Chain

In most instances, FDA believes disputes in the areas covered by this guidance are best 

resolved through a request for internal review through the supervisory chain under 

21 C.F.R. § 10.75. A review through the supervisory chain is an informal process that is 

usually far more timely than any other review option. For this reason, we are providing 

an overview of this important process. For additional information, see the regulation 

itself and the other references cited throughout this guidance. 

Most disputes concerning actions that affect the payment or refund of a MDUFMA fee 

will involve a specific application or submission. The remaining disputes will concern 

whether an applicant qualifies as a small business or government entity. FDA does not 

expect such disputes to involve scientific issues. This overview is written from that 

perspective. 

Overview of 21 C.F.R. § 10.75 as it relates to MDUFMA fees. Upon request of the 

applicant, an FDA decision concerning an application may generally be reviewed by the 

supervisor of the employee who made the decision. A review under 21 C.F.R. § 10.75 

will ordinarily follow the established FDA supervisory or review chain. The review will 

involve consultation between the supervisor and the employee, or review of the 

administrative file by the supervisor. The applicant does not participate in the review. 

In most instances, a review will be completed at a supervisory level below the Center 

Director or the Office of the Commissioner. 

Alternative approaches. In all but the most unusual circumstances, an internal review 

through the supervisory chain can be requested, granted, and completed in far less time 

than other dispute resolution processes provided by FDA regulations. Depending on the 

particular circumstances, alternatives include a citizen petition (21 C.F.R. § 10.30), 

administrative reconsideration of an action (21 C.F.R. § 10.33), a formal evidentiary 

public hearing (21 C.F.R. Part 12), a public hearing before a board of inquiry (21 C.F.R. 

Part 13), a public hearing before a public advisory committee (21 C.F.R. Part 14), a 

public hearing before the FDA Commissioner (21 C.F.R. Part 15), and a regulatory 

hearing before the Food and Drug Administration (21 C.F.R. Part 16). See the guidance 

documents listed in the Background section (p. ) for information on these alternative 

approaches. 
Contains Nonbinding Recommendations 

NOVEMBER 17, 2004 4 

III. Recommended Procedures for Resolving Disputes 

that Affect the Payment or Refund of Medical Device 

User Fees

Questions Concerning the Amount of a Fee or Refund

1. Can I negotiate or appeal the amount of a fee FDA wants me to pay 

or the amount of a refund FDA wants to pay to me?

You cannot appeal the amount of a fee or the amount of a refund. You can appeal the 

FDA action that requires you to pay a particular fee or that will result in a particular 

refund. 

Fee amounts. The fee amounts FDA assesses under MDUFMA are set by FDA each 

year. We follow instructions provided by law when we set these fees. We announce 

updated fees for the next fiscal year by August 2 of each year, and we publish those fees 

in a Federal Register notice. See sections 738(a)(1)(A) and 738(c). Every applicant 

who must pay a MDUFMA fee must pay the published fee that applies to any application 

it submits. 

MDUFMA provides several fee exemptions and waivers and provides for lower fees 

when an applicant has qualified as a “small business,” but MDUFMA does not authorize 

FDA to negotiate the amount of a fee to be paid for a particular application or to waive 

or reduce a fee simply because the fee would present a financial hardship to a particular 

applicant. We can provide a fee waiver or reduction only when the law specifically 

provides us the authority to do so. 

Refunds. FDA will not refund any portion of a MDUFMA review fee — 

• after we have accepted your 510(k) premarket notification; 

• after we have accepted your 180-day PMA supplement; 

• after we have accepted your real-time PMA supplement; 

• after we have taken a first action on your application. 

See question 14, p. , for additional information on these restrictions on refunds. 

In other circumstances, a refund is possible. MDUFMA specifically provides for a 

refund if FDA refuses to file your application or if you withdraw your application within 

time frames set by the law. 
Contains Nonbinding Recommendations 

NOVEMBER 17, 2004 5 

The law requires FDA to refund 75% of a fee if we refuse to file your application or you 

withdraw your application before we make a filing decision. See sections 738(a)(1)(D)(i) 

and 738(a)(1)(D)(ii). 

If you withdraw your application after we make a filing decision but before we take a 

first action, the law gives FDA “sole discretion” to refund “some or all” of the fee “based 

on the level of effort already expended on the review.” Section 738(a)(1)(D)(iii). 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. We have issued guidance 

explaining how we generally intend to make a refund in such situations for traditional 

premarket approval applications (PMAs) and panel-track PMA supplements; see User 

Fees and Refunds for Premarket Approval Applications, available at 

www.fda.gov/cdrh/mdufma/guidance/1224.pdf. 

That guidance explains that, unless there are unusual circumstances, we will normally 

provide such refunds as follows: 

Refund Normally to be Provided when 

a PMA or Panel-track PMA Supplement 

is Withdrawn by the Applicant

When Withdrawn

(Days from Receipt) 

Normal 

Refund 

Amount

Before filing 75% 

After filing to day 90 50% 

Between day 91 and day 135 25% 

After day 135 No refund 

There may be instances where our level of effort is not adequately reflected by looking at 

elapsed time alone. If that is the case, we may adjust the amount of your refund to 

reflect any special circumstances that apply. 

 If you withdraw your application after we make a filing decision but before we take a 

first action, FDA’s decision regarding whether to make a refund of any portion of the 

fee paid for review of that application, and the amount of any such refund, is not 

reviewable. FDA will not consider any appeal, and you cannot obtain judicial review of 

FDA’s decision. See section 738(a)(1)(D)(iii). For additional information on FDA “first 

actions,” see question 14. 
Contains Nonbinding Recommendations 

NOVEMBER 17, 2004 6 

The law does not permit FDA to negotiate the amount of a refund for a particular 

application or to increase the amount of the refund to avoid a financial hardship to a 

particular applicant. The law does not permit FDA to give you a “credit” towards a 

future new application or resubmission of an application. 

2. Will FDA review my application while I proceed with an appeal?

No. FDA cannot review your application if you pay less than the entire amount of any 

fee that applies. This is because the law requires FDA to consider your submission 

“incomplete” and it instructs us that the submission “shall not be accepted for filing . . . 

until all fees owed . . . have been paid.” See section 738(f). If you want FDA to begin a 

review of your application while you appeal an FDA decision that requires you to pay a 

fee, you should pay the fee sought by FDA. If your appeal results in a determination that 

you should have paid a lower fee (or no fee), FDA will refund any excess payment you 

made. 

Appeals Concerning an Applicant’s Status

3. How can I appeal an FDA determination that I am not a “small 

business” under MDUFMA and must pay a full fee rather than a 

reduced or waived “small business” fee?

FDA uses information you provide on a Small Business Qualification Certification (Form 

FDA 3602) to determine whether you are a “small business” within the meaning of 

MDUFMA. This form, instructions, and an explanation of the criteria and process FDA 

will use to evaluate your information, are provided in an FDA guidance document that is 

updated each year. For FY 2005, see — 

• FY 2005 MDUFMA Small Business Qualification Worksheet and Certification

(available at www.fda.gov/cdrh/mdufma/guidance/2005.pdf). 

To qualify as a small business for applications you submit during FY 2005, your “gross 

receipts and sales” — including the gross receipts and sales of all of your affiliates, 

partners, and parent firms — must be no more than $30 million. See sections 

738(d)(2)(C) and 738(e)(2)(C). You must submit a completed Small Business 

Qualification Certification (Form FDA 3602) and copy of your most recent Federal 

(U.S.) income tax return for a taxable year to show that you qualify as a small business. 

FDA cannot accept a foreign tax return as a substitute for a Federal (U.S.) income tax 

return. See sections 738(d)(2)(B) and 738(e)(2)(B). 

Each year, FDA will provide updated guidance on the criteria you must meet to qualify 

as a small business; this may include a revised “gross receipts and sales” threshold. We 

will publish this guidance around the time we publish the Federal Register notice 
Contains Nonbinding Recommendations 

NOVEMBER 17, 2004 7 

announcing MDUFMA fees for the next fiscal year (around August 2 of each year). The 

new guidance will be announced on our Internet site at www.fda.gov/cdrh/mdufma. 

If FDA determines you are a small business, you will be eligible for reduced or waived 

MDUFMA user fees. See sections 738(d)(1) and 738(e)(1). If FDA determines you are 

not a small business, you must pay the full (standard) fee for an application that is 

subject to a fee. 

The fee you must pay for an application is determined and fixed on the date FDA 

receives your application. If you submit an application before FDA has determined you 

qualify as a small business, you must pay the standard (full) amount of any fee that 

applies. FDA will not refund the difference between the standard (full) fee and the small 

business fee if you later qualify as a small business. If you want to pay the small 

business fee for an application, do not submit the application until you obtain your 

Small Business Decision number from FDA.

Examples of issues most likely to be presented on appeal: 

• FDA may find that you did not disclose all of your affiliates, partners, and parent 

firms on your Small Business Qualification Certification. In this case, FDA will 

issue a determination that you are not a small business, but that we will consider 

a new Certification that discloses all omitted affiliates, partners, and parent 

firms. The inclusion of gross receipts or sales of an omitted affiliate, partner, or 

parent firm may take the applicant over the small business threshold ($30 

million for FY 2004 and FY 2005). If you believe FDA’s determination is 

incorrect, you may appeal our finding that a particular entity is an affiliate, 

partner, or parent firm. 

• FDA could make a mathematical error in adding the gross receipts and sales you 

report for yourself and your affiliates, partners, and parent firms, with the error 

resulting in an FDA determination that you do not qualify as a small business. 

You may appeal an FDA determination that is based on such an error. 

Recommended appeals process: You should request an internal review through 

the supervisory chain under 21 C.F.R. § 10.75. The review would proceed through: 

• Initial request for reconsideration: Director, Division of Small Manufacturers, 

International, and Consumer Assistance. 

• Appeal (follows reconsideration): Director, Office of Communication, Education, 

and Radiation Programs (OCER), CDRH. The decision of the Director, OCER, 

would be FDA’s final decision. 
Contains Nonbinding Recommendations 

NOVEMBER 17, 2004 8 

FDA’s final decision regarding whether an entity is a small business is not reviewable. 

FDA will not consider any subsequent appeal, and you cannot obtain judicial review of 

FDA’s decision. See sections 738(d)(2)(D) and 738(e)(2)(D). 

Recommended time frame for making your appeal: You should make your 

appeal within 60 days of FDA’s determination that you are not a small business. FDA 

expects to respond to your appeal within 30 days. 

Send your appeal to: 

All appeals (both CBER and CDRH appeals) should be sent to: 

MDUFMA Appeal 

Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220) 

Center for Devices and Radiological Health 

 Food and Drug Administration 

1350 Piccard Drive 

Rockville, MD 20850-4307

4. How can I appeal an FDA determination that I am not eligible for a 

fee waiver for an application submitted by a government entity?

FDA uses information you provide to determine — 

• whether you are a “State or Federal Government entity” and 

• whether your device is to be “distributed commercially.” 

If we determine you are a government entity and you will not commercially distribute 

your device, you will not have to pay a MDUFMA user fee for that application. See

section 738(a)(1)(B)(iii). If you do not meet both criteria, you must pay any fee that 

applies to your application. 

MDUFMA does not define “State or Federal Government entity.” FDA administers 

another law, the Prescription Drug User Fee Act (PDUFA) that also exempts 

government entities from user fees for drug applications. This guidance uses the same 

definition of “State or Federal Government entity” that FDA is applying under PDUFA. 

Under this definition, you may qualify as a government entity by submitting a letter 

certifying that you meet all of the following criteria: 

• You are an entity operated by a federal department, state, district, territory, 

possession, or federally-recognized Indian tribe. 

• The entire salary of all of your personnel must be directly paid by a federal 

department, state, district, territory, possession, or federally-recognized Indian 

tribe. 
Contains Nonbinding Recommendations 

NOVEMBER 17, 2004 9 

• All of your equipment must be owned, rented by, or leased by a federal 

department, state, district, territory, possession, or federally-recognized Indian 

tribe. 

• The ultimate authority to make day-to-day decisions concerning the management 

and operation of your business must come from a federal department, state, 

district, territory, possession, or federally-recognized Indian tribe. 

Once we have determined you are a governmental entity, you may obtain a waiver of a 

MDUFMA fee for a particular application if you certify that you are a government entity 

and that you do not intend to commercially distribute the device for which you are 

requesting a fee waiver. 

You will certify that you meet these requirements each time you submit an application 

for which you want a fee waiver. FDA will audit these certifications to ensure that 

applicants meet these criteria. 

If we determine that you do not qualify as a government entity or if we determine that 

you will commercially distribute your device, we will send you a letter informing you of 

our determination and summarizing its basis. 

Examples of issues most likely to be presented on appeal: 

• FDA may determine you do not qualify as a government entity because you do 

not appear to be operated by, and subject to oversight of, a State or Federal 

government. 

• FDA may determine that you intend to commercially distribute the device that is 

the subject of your application. 

Recommended appeals process: You should request an internal review through 

the supervisory chain under 21 C.F.R. § 10.75. The review would proceed through: 

• Initial request for reconsideration: Director, Division of Small Manufacturers, 

International, and Consumer Assistance. 

• Appeal (follows reconsideration): Director, Office of Communication, Education, 

and Radiation Programs, CDRH. The decision of the Director, OCER, would be 

FDA’s final decision. 

Recommended time frame for making your appeal: You should make your 

appeal within 60 days of FDA’s determination that you are not a government entity. If 

FDA has determined that you are a government entity, but has determined that your 

device is to be “distributed commercially,” you should appeal within 60 days of FDA’s 

determination that your device will be distributed commercially. FDA expects to 

respond to your appeal within 30 days. 
Contains Nonbinding Recommendations 

NOVEMBER 17, 2004 10 

Send your appeal to: 

All appeals (both CBER and CDRH appeals) should be sent to: 

MDUFMA Appeal 

Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220) 

Center for Devices and Radiological Health 

 Food and Drug Administration 

1350 Piccard Drive 

Rockville, MD 20850-4307

5. How can I appeal an FDA decision to “not file” my application?

If FDA decides to “not file” your application, we will not review your application. FDA 

will refund 75% of the fee you paid (unless you did not pay the correct amount, in which 

case, we will adjust your refund). If you resubmit the application, you must pay the 

entire fee that applies to the application. FDA will not give you a “credit” for the portion 

of the fee that we retained when we determined we could not file your prior application. 

FDA uses the following criteria when making a PMA filing decision: 

• FDA’s regulation, 21 C.F.R. § 814.42 – Filing a PMA; and 

• FDA’s guidance document, Premarket Approval Application Filing Review

(available at www.fda.gov/cdrh/ode/guidance/297.pdf). 

For BLAs, we apply: 

• FDA’s regulation, 21 C.F.R. § 601.2 – Applications for biologics licenses; 

procedures for filing; 

• SOPP 8404, Refusal to File Guidance for Product License Applications and 

Establishment License Applications (October 2002); and 

• SOPP 8404.1, Procedures for Filing an Application When the Applicant Protests 

a Refusal to File Action (File Over Protest) (October 2002). 

For 510(k)s: 

• FDA does not make a filing decision on 510(k)s, so there can be no dispute 

concerning filing of a 510(k). 

Examples of issues most likely to be presented on appeal: 

• These disputes will concern whether your application meets FDA’s minimum 

threshold requirements for filing. If your appeal succeeds, FDA will file your 
Contains Nonbinding Recommendations 

NOVEMBER 17, 2004 11 

application and begin a review as soon as you resubmit the 75% of the fee we 

previously refunded to you. 

Recommended appeals processes: FDA has specific appeals processes for 

resolution of disputes concerning the filing of an application. 

• PMA: The appeals process is established by regulation at 21 C.F.R. 

§ 814.42(d)(2): 

Request in writing within 10 working days of the date of receipt of the notice refusing to file 

the PMA, an informal conference with the Director of the Office of Device Evaluation to review 

FDA's decision not to file the PMA. FDA will hold the informal conference within 10 working 

days of its receipt of the request and will render its decision on filing within 5 working days 

after the informal conference. If, after the informal conference, FDA accepts the PMA for 

filing, the date of filing will be the date of the decision to accept the PMA for filing. If FDA 

does not reverse its decision not to file the PMA, the applicant may request reconsideration of 

the decision from the Director of the Center for Devices and Radiological Health. The 

Director’s decision will constitute final administrative action for the purpose of judicial review.

• BLA: Appeals will follow the process described by SOPP 8005, Major Dispute 

Resolution Process (February 1999), and SOPP 8404.1, Procedures for Filing an 

Application When the Applicant Protests a Refusal to File Action (File Over 

Protest) (October 2002). 

• 510(k): MDUFMA does not authorize a refund of any portion of a fee paid for a 

510(k) that is withdrawn, and FDA will not grant a refund once a 510(k) fee has 

been paid and the 510(k) has been received. See FDA’s guidance document, User 

Fees and Refunds for Premarket Notification Submissions (510(k)s), available at 

— 

www.fda.gov/cdrh/mdufma/guidance/1511.pdf

Because FDA will not provide a refund when a 510(k) is withdrawn, there is no 

appeals process. 

Recommended time frame for making your appeal: 

• PMA: You should make your appeal within “10 working days of the date of 

receipt of the notice refusing to file the PMA.” See 21 C.F.R. § 814.42(d)(2). FDA 

expects to provide its decision “within 5 working days after the informal 

conference” that results from your appeal. Id.

• BLA: You should request a meeting within 30 days of notification of FDA’s 

refusal to file the application. If we still refuse to file your application, you have 

30 days to submit a written request that your application be filed over protest; 
Contains Nonbinding Recommendations 

NOVEMBER 17, 2004 12 

the normal standard or priority review clock will resume when we receive your 

request. 

Send your appeal to: 

CBER filing appeals: (Send your appeal to the office that refused to file your 

application.) 

Director, Office of Blood Research and Review, HFM-300 

Center for Biologics Evaluation and Research 

1401 Rockville Pike, Room 200N 

Rockville, MD 20852-1448 

 or

Director, Office of Cell, Tissue, and Gene Therapies, HFM-700 

Center for Biologics Evaluation and Research 

1401 Rockville Pike, Room 200N 

Rockville, MD 20852-1448

CDRH filing appeals: 

PMA filing appeals: 

Director, Office of Device Evaluation (HFZ-400) 

Center for Devices and Radiological Health 

9200 Corporate Blvd. 

Rockville, MD 20857

6. How can I appeal an FDA determination that I must pay a higher 

fee because my submission is not the type of application I believe it to 

be?

If FDA determines — 

• your submission is not the type of application you claimed, and

• the application type FDA determines it to be requires a higher fee than you paid, 

then FDA will not accept your application until you pay the higher fee. This is because 

under the law your submission “shall be considered incomplete and shall not be 

accepted . . . until all fees owed . . . have been paid.” See section 738(f). 

In such instances, we will fax or mail you a letter (usually within one day) explaining 

that FDA will not file your submission unless you pay the appropriate fee within 30 

days. If you do not pay the appropriate fee within 30 days, FDA will send you a letter 

explaining that the submission was not accepted, that FDA did not review the 

submission, and that the device may not be marketed until your obtain FDA clearance or 

approval. We will also refund any payment you made for review of the submission. 
Contains Nonbinding Recommendations 

NOVEMBER 17, 2004 13 

Examples of issues most likely to be presented on appeal: 

• FDA determined that an application submitted as a 180-day PMA supplement 

must be reviewed as a panel-track supplement or as a PMA. 

• FDA determined that an application submitted as a real-time PMA supplement 

must be reviewed as a 180-day supplement. 

• FDA determined that an application submitted as a 30-day notice must be 

reviewed as a real-time supplement or a 180-day supplement. 

• FDA determined that an application submitted as a BLA supplement for further 

manufacturing use must be reviewed as a BLA efficacy supplement or as a BLA. 

Recommended appeals process: Internal review through the supervisory chain 

under 21 C.F.R. § 10.75 

If FDA determined your application is to be reviewed by CDRH and is a PMA, a paneltrack PMA supplement, a180-day PMA supplement, or a real-time supplement, your 

appeal through the supervisory chain would proceed through: 

• Initial request for reconsideration: Director, Program Operations Staff, ODE, 

CDRH. 

• Appeal (follows reconsideration): Director, Office of Device Evaluation, CDRH 

or Director, Office of In Vitro Diagnostic Device Evaluation and Safety, CDRH. 

(Appeal will be made through the Office that is responsible for regulating your 

device.) 

If FDA determines your application is to be reviewed by CBER and is a PMA, a paneltrack supplement, a 180-day supplement, a real-time supplement, a BLA, or a BLA 

efficacy supplement, your appeal will follow the process described by SOPP 8005, Major 

Dispute Resolution Process (February 1999). 

Recommended time frame for making your appeal: You should make your 

appeal within 30 days of FDA’s decision that your application is a type of application 

that requires a higher fee than you paid. (Note: FDA will delete your application 30 

days after we inform you of our decision that we cannot review it unless you pay the 

higher fee we have determined is due; if we delete your application, we will refund the 

full amount you paid for review of that submission.) FDA expects to respond to your 

appeal within 30 days. 
Contains Nonbinding Recommendations 

NOVEMBER 17, 2004 14 

Send your appeal to: 

CBER appeals: (Send your appeal to the office that would review your application.) 

Director, Office of Blood Research and Review (HFM-300) 

 Center for Biologics Evaluation and Research 

 1401 Rockville Pike, Room 200N 

 Rockville, MD 20852-1448 

 

 or

 

 Director, Office of Cell, Tissue, and Gene Therapies (HFM-700) 

 Center for Biologics Evaluation and Research 

 1401 Rockville Pike, Room 200N 

 Rockville, MD 20852-1448

CDRH appeals: 

Director, Program Operations Staff (HFZ-402) 

 Office of Device Evaluation 

 Center for Devices and Radiological Health 

 9200 Corporate Blvd. 

 Rockville, MD 20857

7. How can I appeal an FDA determination that its review of my 

application had reached a particular stage when I withdrew the 

application?

The stage at which a review is terminated when you withdraw an application determines 

the amount of the fee FDA will refund: 

• FDA will refund 75% of the fee if you withdraw your application before FDA files 

the application. Section 738(a)(1)(D)(ii). 

• If FDA has filed your application, but has not yet taken a first action, FDA has 

“sole discretion” to refund “some or all” of the fee “based on the level of effort 

already expended on the review.” Section 738(a)(1)(D)(iii). The answer to 

question 1, p. , provides information on the amount of the refund you can expect. 

If you want a refund when you withdraw your application, you must make a “written 

request” for a refund “not later than 180 days after such fee is due.” Section 738(j). All 

fees are due at the time the application is filed or accepted. See section 738(f). This 

means your request for a refund must be made within 180 days of the date FDA filed or 

accepted your application. If you do not request a refund when you withdraw your 

application, or you delay too long in making your request, FDA will not provide any 

refund. 
Contains Nonbinding Recommendations 

NOVEMBER 17, 2004 15 

The law does not authorize any refund of a 510(k) fee after FDA files the application. 

See section 738(a)(1)(D)(iii). Also, FDA has determined that we will not provide any 

refund — 

• after we have accepted your 180-day PMA supplement; or 

• after we have accepted your real-time PMA supplement. 

FDA considers your 180-day or real-time PMA supplement to be filed as soon as we 

have received your supplement and you have paid the fee due for the review. Under 

section 738(a)(1)(D)(iii), after FDA has filed an application, we are to base any refund 

on the level of effort we expended. Because the fees for these supplements are much 

lower than the fee for an original premarket application and because these reviews are 

conducted under a shorter period of time, we have determined that the level of effort 

required to review these supplements is so significant that any refund would be 

unwarranted. 

Examples of issues most likely to be presented on appeal: 

• When did FDA receive notice that the applicant was withdrawing the application? 

• Did FDA file the application prior to receiving notice that the applicant was 

withdrawing the application? 

• Did FDA take a first action prior to receiving notice that the applicant was 

withdrawing the application? 

Recommended appeals process: Internal review through the supervisory chain 

pursuant to 21 C.F.R. § 10.75. 

Appeals through the CDRH supervisory chain would proceed through: 

• Initial request for reconsideration: Chief, Premarket Approval Section, Program 

Operations Staff, ODE, CDRH. 

• Appeal (follows reconsideration): Director, Program Operations Staff, ODE, 

CDRH. 

• Final decision (follows appeal): Director, Office of Device Evaluation, CDRH or

Director, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), 

CDRH. (Appeal will be made through the Office that is responsible for regulating 

your device.). The ODE or OIVD Director’s decision would constitute final 

administrative action concerning the stage of review your application was at 

when you withdrew it, and the time at which the review was terminated. FDA’s 

decision concerning the amount of any refund to be provided after a first action 

“shall not be reviewable.” Section 738(a)(1)(D)(iii). 

Appeals through the CBER supervisory chain will follow the process described by SOPP 

8005, Major Dispute Resolution Process (February 1999), and would proceed through: 
Contains Nonbinding Recommendations 

NOVEMBER 17, 2004 16 

• Director, Office of Blood Research and Review 

 or

 Director, Office of Cell, Tissue, and Gene Therapies 

• Deputy Center Director, CBER 

• Center Director, CBER 

If FDA has filed your application, but has not yet taken a first action, FDA has “sole 

discretion” to refund “some or all” of the fee you paid “based on the level of effort 

already expended on the review.” Section 738(a)(1)(D)(iii). In most instances, FDA 

believes our level of effort can be appropriately estimated by determining how much 

time has elapsed since we filed the application. There may be instances where our level 

of effort is not adequately reflected by looking at elapsed time alone, and our refund will 

reflect any special circumstances that apply. We will normally provide refunds as 

follows: 

Refund Normally to be Provided when 

a PMA or Panel-track PMA Supplement 

is Withdrawn by the Applicant

When Withdrawn

(Days from Receipt) 

Normal 

Refund 

Amount

Before filing 75% 

After filing to day 90 50% 

Between day 91 and day 135 25% 

After day 135 No refund 

See question 1 for additional information. 

Whenever an application is withdrawn after filing but before a first action, FDA’s 

decision regarding whether to make a refund of any portion of the fee paid for review 

of that application, and the amount of any such refund, is not reviewable. FDA will not 

consider any appeal, and you cannot obtain judicial review of FDA’s decision. See

section 738(a)(1)(D)(iii). 

FDA has no authority to make any refund after we have taken a first action. See

section 738(a)(1)(D). 
Contains Nonbinding Recommendations 

NOVEMBER 17, 2004 17 

Recommended time frame for making your appeal: You should make your 

appeal within 60 days of FDA’s refund decision. FDA expects to respond to your appeal 

within 30 days. 

Send your appeal to: 

CBER appeals: (Send your appeal to the office that was reviewing your application.) 

Director, Office of Blood Research and Review, HFM-300 

Center for Biologics Evaluation and Research 

1401 Rockville Pike, Room 200N 

Rockville, MD 20852-1448 

 or

Director, Office of Cell, Tissue, and Gene Therapies, HFM-700 

Center for Biologics Evaluation and Research 

1401 Rockville Pike, Room 200N 

Rockville, MD 20852-1448

CDRH appeals: 

 Chief, Premarket Approval Section (HFZ-402) 

 Program Operations Staff 

Office of Device Evaluation 

 Center for Devices and Radiological Health 

 9200 Corporate Blvd. 

Rockville, MD 20857 

8. How can I appeal an FDA determination that a premarket 

application I submitted is not my first?

Section 738(d)(1) provides FDA “shall grant a waiver of the fee required . . . for one 

premarket application, or one premarket report, where . . . the applicant involved is a 

small business submitting its first premarket application . . . or its first premarket report 

. . . for review.” 

This discussion assumes FDA has already found that you are a “small business” (only a 

“small business” can obtain a waiver of the fee for its first PMA or first PMR). If that is 

not the case, see question 3. 
Contains Nonbinding Recommendations 

NOVEMBER 17, 2004 18 

Examples of issues most likely to be presented on appeal: 

• If you are requesting a waiver for your first premarket application (PMA, PDP, 

PMR, or BLA), FDA may determine that you previously submitted a premarket 

application.1

• FDA may determine that one of your affiliates, partners, or parent firms 

previously submitted a premarket application. 

Recommended appeals process: Internal review through the supervisory chain 

pursuant to 21 C.F.R. § 10.75 

 Appeals through the CDRH supervisory chain would proceed through: 

• Initial request for reconsideration: Director, Program Operations Staff, ODE 

• Appeal (follows reconsideration): Director, Office of Device Evaluation, 

CDRH or Director, Office of In Vitro Diagnostic Device Evaluation and Safety, 

CDRH. (Appeal will be made through the Office that is responsible for 

regulating your device.) The ODE or OIVD Director’s decision would 

constitute final administrative action. 

Appeals through the CBER supervisory chain will follow the process described by SOPP 

8005, Major Dispute Resolution Process (February 1999), beginning with the Director 

of the Office that was reviewing your application. 

Special considerations: Only a small business is eligible for a fee waiver for its first 

premarket application under section 738(d)(1). To qualify for this waiver, you must 

establish your status as a small business before you submit your first premarket 

application. If you have not qualified as a small business at the time you submit your 

application, you must pay the full fee for that application. 

Recommended time frame for making your appeal: You should make your 

appeal within 60 days of FDA’s determination that a premarket application you 

submitted is not your first. FDA expects to respond to your appeal within 30 days. 

 

1 If you are requesting a waiver for your first premarket report (PMR) for a 

reprocessed single-use device and you submitted a premarket approval application

(PMA), for the same device prior to October 1, 2002, you may still obtain a fee waiver 

for that PMR. See section 102(b) of MDUFMA (this waiver is not codified as part of the 

FD&C Act). This provision is intended to avoid penalizing an applicant who previously 

submitted a PMA for a reprocessed device, but who must submit a new application to 

satisfy requirements added by MDUFMA.
Contains Nonbinding Recommendations 

NOVEMBER 17, 2004 19 

Send your appeal to: 

CBER appeals: 

 Director, Office of Blood Research and Review (HFM-300) 

 Center for Biologics Evaluation and Research 

 1401 Rockville Pike, Room 200N 

 Rockville, MD 20852-1448 

 

 or

 

 Director, Office of Cell, Tissue, and Gene Therapies (HFM-700) 

 Center for Biologics Evaluation and Research 

 1401 Rockville Pike, Room 200N 

 Rockville, MD 20852-1448

CDRH appeals: 

Director, Program Operations Staff (HFZ-402) 

 Office of Device Evaluation 

 Center for Devices and Radiological Health 

 9200 Corporate Blvd. 

 Rockville, MD 20857

9. How can I appeal FDA’s designation of the primary review process 

for my combination product?

FDA’s Office of Combination Products (OCP) assigns the review responsibility for a 

combination product based on the product’s “primary mode of action.” Section 

503(g)(1). 

You may obtain an FDA determination concerning your combination product’s primary 

mode of action by submitting a “Request for Designation” (RFD) to OCP. OCP will make 

a determination within 60 days. The RFD process is outlined in 21 C.F.R. Part 3; 21 

C.F.R. § 3.7 outlines the information we require in your RFD submission. 

When OCP determines the primary mode of action of your product, that action will also 

determine how FDA will review and regulate your product. For example, when OCP 

determines that primary mode of action results from a drug component, that product 

will be reviewed and regulated as a drug by the Center for Drug Evaluation and 

Research. The primary review process may be subject to a user fee, either under 

MDUFMA or the Prescription Drug User Fee Act (PDUFA). PDUFA fees are higher than 

fees under MDUFMA, and may include both an application fee and annual product and 

establishment fees. 
Contains Nonbinding Recommendations 

NOVEMBER 17, 2004 20 

Criteria: The term combination product is defined at 21 C.F.R. § 3.2(e): 

Combination product includes: 

(1) A product comprised of two or more regulated components, i.e., drug/device, 

biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or 

otherwise combined or mixed and produced as a single entity; 

(2) Two or more separate products packaged together in a single package or as a unit and 

comprised of drug and device products, device and biological products, or biological and drug 

products; 

(3) A drug, device, or biological product packaged separately that according to its 

investigational plan or proposed labeling is intended for use only with an approved 

individually specified drug, device, or biological product where both are required to achieve 

the intended use, indication, or effect and where upon approval of the proposed product the 

labeling of the approved product would need to be changed, e.g., to reflect a change in 

intended use, dosage form, strength, route of administration, or significant change in dose; or 

(4) Any investigational drug, device, or biological product packaged separately that according 

to its proposed labeling is for use only with another individually specified investigational drug, 

device, or biological product where both are required to achieve the intended use, indication, 

or effect.

The Office of Combination Products assigns primary jurisdiction for a combination 

product to a particular Center based on the “primary mode of action” of the product. In 

making its determination, OCP refers to — 

• Intercenter agreements relating to the review of combination products; 

• Regulation of Combination Products: FDA Employee Perspectives (October 

2002); and 

• Manual of Standard Operating Procedures and Policies – General Information 

– Review: Intercenter Consultative/Collaborative Review Process (Version 2, 

February 14, 2003). 

FDA has published a proposed rule, Definition of Primary Mode of Action for a 

Combination Product, 69 F.R. 25527 (May 7, 2004), but has not yet published a final 

rule. If a final rule goes into effect, it will provide the criteria FDA will use to determine 

primary mode of action. The proposed rule is available at 

www.fda.gov/OHRMS/DOCKETS/98fr/04-10447.pdf. OCP will provide additional 

information on its Internet site, www.fda.gov/oc/combination. 

Examples of issues most likely to be presented on appeal: 

• An FDA determination that an application for a combination product is to be 

regulated primarily as a human drug under section 505(b) of the Federal Food, 

Drug, and Cosmetic Act rather than as a device regulated under section 515 or 

section 510(k) of the FD&C Act or under section 351 of the Public Health Service 

Act. 
Contains Nonbinding Recommendations 

NOVEMBER 17, 2004 21 

Recommended appeals process: Internal review through the supervisory chain 

pursuant to 21 C.F.R. § 10.75 

All appeals will proceed through: 

• Initial request for reconsideration: Director, Office of Combination Products, 

Office of the Commissioner. 

• Appeal: (follows reconsideration): Principal Associate Commissioner, FDA. 

Recommended time frame for making your appeal: You should make your 

appeal before you submit your application to FDA. FDA expects to respond to your 

appeal within 30 days. 

Send your appeal to: 

Director, Office of Combination Products (HF-7) 

 Office of the Commissioner 

 Food and Drug Administration 

 5600 Fishers Lane 

 Rockville, MD 20857

10. What can I do if FDA does not review and act on my combination 

product application in a timely manner?

If an issue remains unresolved after working with the lead Center, FDA’s Office of 

Combination Products (OCP) can help facilitate a resolution of the issue. OCP has 

published a draft guidance document that provides additional information and explains 

how OCP can help. See Combination Products — Timeliness of Premarket Reviews — 

Dispute Resolution Guidance, available at www.fda.gov/oc/combination/dispute.pdf. 

11. How can I appeal an FDA determination that I cannot “bundle” a 

device into a single application involving multiple devices? How can I 

appeal an FDA determination that I cannot “bundle” an indication for 

use of a device into a single application involving multiple indications 

for use for that device?

The extent to which bundling is, or is not, permitted in a particular case will determine 

whether the applicant pays a fee for a single application, or multiple fees for multiple 

applications. 

All bundled devices should be within a generic type of device, and it should be possible 

for FDA to efficiently address all issues during the course of one review. 
Contains Nonbinding Recommendations 

NOVEMBER 17, 2004 22 

Before you submit a bundled application to FDA, you should review FDA’s guidance, 

Bundling Multiple Devices or Multiple Indications in a Single Submission, available at 

— 

www.fda.gov/cdrh/mdufma/guidance/1215.pdf

If you are unsure whether bundling is appropriate in your circumstances, you should 

contact FDA before you make your submission. 

Examples of issues most likely to be presented on appeal: 

• Are bundled devices within a generic type of device, and do they present issues 

that can be efficiently addressed during the course of one review? 

• Are the indications for use desired by applicant sufficiently related that they can 

all be efficiently addressed during the course of one review? 

Recommended appeals process: Internal review through the supervisory chain 

pursuant to 21 C.F.R. § 10.75 

Appeals through the CDRH supervisory chain would proceed through: 

• Initial request for reconsideration: Director, Program Operations Staff, ODE 

• Appeal (follows reconsideration): Director, Office of Device Evaluation, CDRH 

or Director, Office of In Vitro Diagnostic Device Evaluation and Safety, CDRH. 

(Appeal will be made through the Office that is responsible for regulating your 

device.) 

Appeals through the CBER supervisory chain will follow the process described by SOPP 

8005, Major Dispute Resolution Process (February 1999), beginning with the Director 

of the Office that was reviewing your application: 

• Initial request for reconsideration: 

 — Director, Office of Blood Research and Review, or

 — Director, Office of Cell, Tissue, and Gene Therapies 

• Appeal (follows reconsideration): Deputy Center Director, CBER 

Recommended time frame for making your appeal: FDA expects to respond to 

your appeal within 30 days. 
Contains Nonbinding Recommendations 

NOVEMBER 17, 2004 23 

Send your appeal to: 

CBER appeals (send your appeal to the Office that would review your application): 

 Director, Office of Blood Research and Review (HFM-300) 

 Center for Biologics Evaluation and Research 

 1401 Rockville Pike, Room 200N 

 Rockville, MD 20852-1448 

 

 or

 

 Director, Office of Cell, Tissue, and Gene Therapies (HFM-700) 

 Center for Biologics Evaluation and Research 

 1401 Rockville Pike, Room 200N 

 Rockville, MD 20852-1448

CDRH appeals: 

Director, Program Operations Staff (HFZ-402) 

 Office of Device Evaluation 

 Center for Devices and Radiological Health 

 9200 Corporate Blvd. 

 Rockville, MD 20857

12. How can I appeal an FDA determination that my application is not

solely for a pediatric population?

Under section 738(a)(1)(B)(v)(I), FDA does not assess a fee for any application, or any 

supplement to an application, that is intended solely for a pediatric population. If your 

application includes an indication for any adult use, you must pay the fee that would 

normally apply to your application. 

If you obtained a fee waiver for your original premarket application (PMA, PDP, PMR, 

or BLA) because it was intended solely for a pediatric population, and you later submit a 

supplement that proposes an adult condition of use, you will be required to pay the fee 

that would apply to an original application rather than the lower fee that would 

normally apply to your supplement. See section 738(a)(1)(B)(v)(II). 

FDA cannot confirm your claim that an application is limited to pediatric indications 

until the application is filed and we have made significant progress in our review of the 

application. If, during our review, we identify a proposed adult use in an original 

application you claim is intended solely for a pediatric population, we will put your 

application on hold and suspend our review because under section 738(f) your 

application “shall be considered incomplete . . . until all fees owed . . . have been paid.” 

We will inform you your application is on hold, usually within a day. We will not resume 
Contains Nonbinding Recommendations 

NOVEMBER 17, 2004 24 

our review until you pay the appropriate fee, or you remove the proposed adult use from 

your application, or an appeal determines there is no proposed adult use. 

Similarly, if you obtained a fee waiver for your original application because it was 

represented as solely for a pediatric population, and we identify a proposed adult use in 

a later supplement to that application, and you did not include payment for an original

application, we will put your application on hold and suspend our review, because under 

section 738(a)(1)(B)(v)(II) you must pay that higher fee and under section 738(f) your 

application “shall be considered incomplete . . . until all fees owed . . . have been paid.” 

We will inform you your application is on hold, usually within a day. We will not resume 

our review until you pay the appropriate fee, or you remove the proposed adult use from 

your supplement, or an appeal determines there is no proposed adult use. 

Examples of issues most likely to be presented on appeal: 

• Is there any indication for an adult use? 

Recommended appeals process: Internal review through the supervisory chain 

pursuant to 21 C.F.R. 10.75 — 

Appeals through the CDRH supervisory chain would proceed through: 

• Initial request for reconsideration: Director, Program Operations Staff, ODE 

• Appeal (follows reconsideration): Director, Office of Device Evaluation, CDRH 

or Director, Office of In Vitro Diagnostic Device Evaluation and Safety, CDRH. 

(Appeal will be made through the Office that is responsible for regulating your 

device.) 

Appeals through the CBER supervisory chain will follow the process described by SOPP 

8005, Major Dispute Resolution Process (February 1999), beginning with the Director 

of the Office that was reviewing your application. 

• Initial request for reconsideration: 

 — Director, Office of Blood Research and Review, or

 — Director, Office of Cell, Tissue, and Gene Therapies 

• Appeals (follows reconsideration): Deputy Center Director, CBER 

Recommended time frame for making your appeal: You should make your 

appeal within 60 days of FDA’s determination that your application includes an 

indication for an adult use. FDA expects to respond to your appeal within 30 days. 
Contains Nonbinding Recommendations 

NOVEMBER 17, 2004 25 

Send your appeal to: 

CBER appeals: (Send your appeal to the office that was reviewing your application.) 

Director, Office of Blood Research and Review, HFM-300 

Center for Biologics Evaluation and Research 

1401 Rockville Pike, Room 200N 

Rockville, MD 20852-1448 

 or

Director, Office of Cell, Tissue, and Gene Therapies, HFM-700 

Center for Biologics Evaluation and Research 

1401 Rockville Pike, Room 200N 

Rockville, MD 20852-1448

CDRH appeals: 

Director, Program Operations Staff (HFZ-402) 

 Office of Device Evaluation 

 Center for Devices and Radiological Health 

 9200 Corporate Blvd. 

 Rockville, MD 20857

13. I accidentally submitted a duplicate (second) payment for my 

application. Can I obtain a refund of the extra amount I paid?

Yes. FDA will grant all requests for refund of any portion of a payment that exceeds the 

correct fee for your application. Submit written documentation of your duplicate 

payment to the Center that received your application: 

CDRH: CBER: 

 Financial Management Branch (HFZ-30) Regulatory Information Management Staff (HFM-110) 

 Division of Planning, Analysis, and Finance Office of Management 

 Office of Systems and Management Center for Biologics Evaluation and Research 

 2098 Gaither Rd. 1401 Rockville Pike, Room 200N 

 Rockville, MD 20857 Rockville, MD 20852-1448
Contains Nonbinding Recommendations 

NOVEMBER 17, 2004 26 

14. I paid a fee for review of a 510(k), and FDA determined that my 

device is exempt from the requirement for a 510(k) premarket 

notification, or I paid a fee for review of a 510(k) or a PMA, and FDA 

determined that my product is not a device. Can I obtain a refund of 

the amount I paid?

Yes. FDA will automatically refund the fee you paid whenever we determine that our 

classification regulation exempts your device from the requirement to submit a 

premarket notification, or we determine your product is not a device. For additional 

information, see our guidance documents — 

• User Fees and Refunds for Premarket Notification Submissions (510(k)s), 

available at www.fda.gov/cdrh/mdufma/guidance/1511.pdf. 

• User Fees and Refunds for Premarket Approval Applications, 

available at www.fda.gov/cdrh/mdufma/guidance/1224.pdf. 

15. Are there instances where I cannot obtain a refund of any portion 

of a fee I have paid for review of a medical device application?

FDA will not refund any portion of a fee you paid if any one or more of the following 

situations — 

• after we have accepted your 510(k) premarket notification; 

• after we have accepted your 180-day PMA supplement; 

• after we have accepted your real-time PMA supplement; 

• after we have taken a first action on your application. 

No refund after we have accepted your 510(k) premarket notification. 

MDUFMA does not authorize a refund of any portion of a fee paid for a 510(k) that is 

withdrawn, and FDA will not grant a refund once a 510(k) fee has been paid and the 

510(k) has been received. See FDA’s guidance document, User Fees and Refunds for 

Premarket Notification Submissions (510(k)s), available at 

www.fda.gov/cdrh/mdufma/guidance/1511.pdf. 

No refund after we have accepted your 180-day PMA supplement or your 

real-time PMA supplement. FDA considers your 180-day or real-time PMA 

supplement to be filed as soon as we have received your supplement and you have paid 

the fee due for the review. Under section 738(a)(1)(D)(iii), after FDA has filed an 

application, we are to base any refund on the level of effort we expended. Because the 

fees for these supplements are much lower than the fee for an original premarket 

application and because these reviews are conducted under a shorter period of time, we 
Contains Nonbinding Recommendations 

NOVEMBER 17, 2004 27 

have determined that the level of effort required to review these supplements is so 

significant that any refund would be unwarranted. 

For additional information, see FDA’s guidance, User Fees and Refunds for Premarket 

Approval Applications, available at www.fda.gov/cdrh/mdufma/guidance/1224.pdf. 

No refund following a first action on your application. Under 

section 738(a)(1)(D), FDA does not have authority to grant a refund of any portion of a 

MDUFMA fee payment after we taken a first action. FDA will deny any request for a 

refund after we take a first action, and we will deny any appeal that requests a refund 

after a first action. 

• For an original PMA, PDP, PMR, or a panel-track PMA supplement, a first 

action may be any of the following actions: approval, approvable, approvable 

pending good manufacturing practices (GMP) inspection, major deficiency letter, 

not approvable, or denial. 

• For an original BLA or a BLA efficacy supplement, a resubmission of an 

original BLA or resubmission of a BLA efficacy supplement, or a BLA 

manufacturing supplements requiring prior approval, first action means the 

issuance of a complete action letter after the complete review of a filed complete 

application. 

16. If FDA determines I should receive a refund, how soon should I 

expect to receive my refund check?

FDA expects to send you a check for the full amount of your refund within 30 days after 

we determine you are entitled to a refund. 
Contains Nonbinding Recommendations 

NOVEMBER 17, 2004 28 

IV. Sources for Additional Information

17. How can I obtain more information about a particular 

appeals process?

You can obtain additional information and guidance on FDA’s appeals processes by 

reviewing the guidance documents and SOPPs referenced in this document. If you still 

have a question, contact — 

CBER Ombudsman: (For information about CBER appeals) 

CBER Ombudsman (HFM-4) 

Center for Biologics Evaluation and Research 

Food and Drug Administration 

1401 Rockville Pike 

 Rockville, MD 20852-1448 

Phone: 301-827-0379 

 Internet site: www.fda.gov/cber/inside/ombudsman.htm

CDRH Ombudsman: (For information about CDRH appeals) 

CDRH Ombudsman (HFZ-5) 

Center for Devices and Radiological Health 

Food and Drug Administration 

9200 Corporate Blvd. 

Rockville, MD 20850 

Phone: 301-827-7991 

 Internet site: www.fda.gov/cdrh/ombudsman

FDA Ombudsman: (For information about an appeal of FDA’s designation of the 

primary review process for a combination product.) 

Office of the Ombudsman (HF-7) 

Office of the Commissioner 

Food and Drug Administration 

5600 Fishers Lane 

Room 14B03 

Rockville, MD 20857 

Phone: 301-827-3390 

 Internet site: www.fda.gov/oc/ombudsman/homepage.htm

E-mail: ombuds@oc.fda.gov
Contains Nonbinding Recommendations 

NOVEMBER 17, 2004 29 

FDA Office of Combination Products: (For information about how OCP can help 

facilitate the resolution of issues concerning timeliness of reviews of combination 

products. 

Office of Combination Products (HFG-3) 

Office of the Commissioner 

Food and Drug Administration 

Suite 200 

 15800 Crabbs Branch Way 

Rockville, MD 20855 

Phone: 301-427-1934 

 Internet site: www.fda.gov/oc/ombudsman/homepage.htm

E-mail: combination@fda.gov

18. How can I obtain more information about MDUFMA?

For general information about MDUFMA, visit FDA’s web sites at — 

• www.fda.gov/cdrh/mdufma — Provides the full text of the law, plain-language 

summaries, answers to frequently-asked questions, Federal Register notices, 

important announcements, guidance documents, and more.

• www.fda.gov/cber/mdufma/mdufma.htm — Similar information, with a focus on 

biologics devices. 

For additional information on MDUFMA user fees and refunds, see — 

• User Fees and Refunds for Premarket Notification Submissions (510(k)s), 

available at — www.fda.gov/cdrh/mdufma/guidance/1511.pdf. 

• User Fees and Refunds for Premarket Approval Applications, available at — 

www.fda.gov/cdrh/mdufma/guidance/1224.pdf.