Guidance for 

Industry and FDA Staff 

User Fees and Refunds for 

Premarket Notification Submissions 

(510(k)s) 

Document issued on: May 28, 2004 

For questions regarding submissions to the Center for Devices and Radiological Health, 

contact Heather S. Rosecrans at 240-276-4021 or by email at heather.rosecrans@fda.hhs.gov

For questions regarding submissions to the Center for Biologics Evaluation and Research, 

contact Leonard Wilson at 301 827-0373 or by email at wilsonl@cber.fda.gov. 

U.S. Department of Health and Human Services 

Food and Drug Administration 

Center for Devices and Radiological Health 

Center for Biologics Evaluation and Research 
Contains Nonbinding Recommendations 

Preface

Public Comment

Written comments and suggestions may be submitted at any time for Agency consideration 

to Dockets Management Branch, Division of Management Systems and Policy, Office of 

Human Resources and Management Services, Food and Drug Administration, 5630 Fishers 

Lane, Room 1061, (HFA-305), Rockville, MD, 20852. Alternatively, electronic comments 

may be submitted to http://www.fda.gov/dockets/ecomments. Please identify your comments 

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

Register announcing the availability of this guidance document. Comments may not be acted 

upon by the Agency until the document is next revised or updated. 

Additional Copies 

Additional copies are available from the Internet at: 

http://www.fda.gov/cdrh/mdufma/guidance/1511.pdf or 

http://www.fda.gov/cber/mdufma/mdufma.htm, or by phone at (301) 827-2000 or (800) 835-

4709, or to receive this document by fax, call the CDRH Facts-On-Demand system at 800-

899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the 

second voice prompt, press 1 to order a document. Enter the document number (1511) 

followed by the pound sign (#). Follow the remaining voice prompts to complete your 

request. 
Contains Nonbinding Recommendations 

Table of Contents 

Introduction............................................................................................................................... 1 

Stakeholder Input...................................................................................................................... 1 

Frequently Asked Questions..................................................................................................... 2 

1. Are all 510(k)s subject to user fees? ............................................................................. 2

2. Are 510(k)s reviewed by a European Union Conformity Assessment Body (EU CAB)

subject to user fees? ...................................................................................................... 3

3. Will the agency assess a fee if FDA determines that my device was not eligible for 

review by a third party or an EU CAB?........................................................................ 3

4. Will FDA refund the user fee if I submit a 510(k) that is not required?....................... 3

5. Are there fees for a new submission if I previously received a not substantially 

equivalent (NSE) determination for my device? .......................................................... 5

6. Are there fees assessed if I submit additional information to a pending 510(k)?......... 6

7. Will FDA refund the user fee if I withdraw my 510(k)? .............................................. 6

8. Will FDA require a new user fee if I withdraw and resubmit my 510(k)?.................... 6

9. If my 510(k) is considered withdrawn because I failed to supply requested 

information, will FDA require a new user fee if I resubmit my 510(k)?...................... 7

Table 1. 510(k) User Fees........................................................................................................ 7 

Table 2. Refunds of 510(k) Fees.............................................................................................. 8

Table 3. Fees for Resubmission Following NSE Determination............................................. 8 
Contains Nonbinding Recommendations 

Guidance for Industry and FDA Staff 

User Fees and Refunds for Premarket 

Notification Submissions (510(k)s)

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. 

Introduction 

The Medical Device User Fee and Modernization Act of 2002 (MDUFMA), Public Law 107-

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

Drug Administration (FDA) new responsibilities and resources. A provision of MDUFMA 

authorizes FDA to collect user fees for the review of certain premarket submissions received 

on or after October 1, 2002, including premarket notification submissions (510(k)s). The 

additional funds obtained from user fees will enable FDA, with the cooperation of industry, 

to improve the device review process in order to meet the performance goals identified in the 

letter from the Secretary of Health and Human Services to Congress 

(http://www.fda.gov/cdrh/mdufma/pgoals.html). The purpose of this document is to assist

FDA staff and regulated industry by describing the user fees and refunds associated with the 

510(k) Program.

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. 

Stakeholder Input 

On February 4, 2003, FDA published a notice in the Federal Register (68 FR 5643) to 

establish a public docket, 02N-0534, so that we could share information on the 

implementation of MDUFMA and to provide interested persons an opportunity to share their 

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Contains Nonbinding Recommendations 

views. On December 3, 2003, the agency held an open public meeting to update its 

stakeholders on its progress in implementing the new law, discuss some of MDUFMA’s more 

challenging provisions, and obtain input from interested parties. Since establishing the docket 

over a year ago, the agency has received quite a few comments from its stakeholders on a 

number of MDUFMA provisions, including the application and refund of user fees. During 

the drafting of this guidance, the agency specifically solicited comments to the docket in 

recognition of the interest in this issue. 

The agency considered all comments received to date and believes that the approach presented 

below is a fair application of its refund policy. FDA wishes to emphasize that the agency and 

industry should work to limit the amount of resources that may be expended unnecessarily on 

devices that do not require agency review. FDA believes that those resources are better spent 

on reviewing applications that require and will benefit from regulatory oversight. Therefore, 

we encourage submitters to take advantage of all resources available to them before 

submitting a premarket notification. By availing themselves of the assistance that is available 

in the classification regulations, guidances, and consultation with CDRH and CBER staff, 

both FDA and industry can focus their limited resources on those devices that will most 

benefit from agency oversight. 

 

Frequently Asked Questions 

1. Are all 510(k)s subject to user fees? 

In accordance with MDUFMA,1

 all 510(k)s (traditional, abbreviated, and specials)2 are 

subject to user fees, except those listed below. The 510(k)s that are not subject to user 

fees are those: 

• reviewed by an FDA-accredited third party pursuant to section 523 of the act 

(section 738(a)(1)(B)(iv) of MDUFMA) 

• submitted for devices intended solely for a pediatric population (section 

738(a)(1)(B)(v)(I) of MDUFMA)3,4

 

1

 See section 738(a)(a)(A)(vii).

2

 For more information on the 510(k) Program generally, please refer to Device Advice at: 

www.fda.gov/cdrh/devadvice/; for more information on traditional, abbreviated, and special

510(k)s, see The New 510(k) Paradigm at www.fda.gov/cdrh/ode/parad510.html. 3

 There may be situations in which, upon review of the device and its intended population, 

FDA determines that the submission qualified for the pediatric exemption although the 

manufacturer did not request a waiver. In such a case, FDA intends to refund the user fee.

4

 For guidance on the type of safety and effectiveness information needed to support marketing 

of pediatric devices and on measures to be used to help protect pediatric subjects during the 

course of clinical trials involving such devices, see the guidance entitled, “Premarket 

Assessment of Medical Devices” at www.fda.gov/cdrh/mdufma/guidance/1220.html. 

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Contains Nonbinding Recommendations 

• submitted by a state or federal government entity, unless the device involved is to 

be distributed commercially (section 738(a)(1)(B)(iii) of MDUFMA). 

If you mistakenly submit a fee with any of these types of 510(k)s, FDA will refund the 

fee. 

2. Are 510(k)s reviewed by a European Union Conformity Assessment Body (EU CAB) 

subject to user fees? 

Although not addressed by MDUFMA, FDA does not intend to assess user fees for 

510(k)s reviewed by EU CABs.5

 FDA believes that because EU CABs are serving the 

same function as FDA-accredited third parties, no fee should be assessed. 

3. Will the agency assess a fee if FDA determines that my device was not eligible for 

review by a third party or an EU CAB? 

Generally, no. If a third party submits a recommendation for a device that appears to be 

on the list of eligible device types, FDA will not assess a user fee if the agency 

determines that the device was not appropriate for third party review (e.g., because the 

device requires clinical data or review by multiple FDA centers).6

 If, however, the 

device does not appear on the list and it is not eligible for third party review, FDA plans 

to assess the user fee.7

 

4. Will FDA refund the user fee if I submit a 510(k) that is not required? 

Yes, under certain circumstances. FDA will refund user fees for submissions that are not 

required because the agency determines that a product is not a device or because there is 

a classification regulation that exempts the device from 510(k) review.8

 However, if the 

device exceeds the limitations to exemption from the 510(k) requirements of the act, a 

new 510(k) and user fee would be required. 

 

5

 See Implementation of Third Party Programs Under the FDA Modernization Act of 1997 

at: http://www.fda.gov/cdrh/thirdparty/apguide13.html and Guidance for Staff, Industry and 

Third Parties: Third Party Programs Under the Sectoral Annex on Medical Devices to the 

Agreement on Mutual Recognition Between the United States of America and the 

European Community (MRA) at: http://www.fda.gov/cdrh/modact/eurma.html. 6

 Devices eligible for third party review are accessible from http://www.fda.gov/cdrh/thirdparty/. 7

 A device may be eligible for third party review even if it does not appear of the list if it is a 

Class I or II device that has been exempted from 510(k) by regulation but requires a 510(k) 

because it exceeds the limitations of the exemption (as discussed in FDA’s device 

classification regulations).

8

 This would include general purpose articles and other products that are exempt from 

registration and listing under 21 CFR 807.65. 

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Contains Nonbinding Recommendations 

The agency does not intend to refund fees for any other 510(k)s that are submitted for 

review. FDA reviewed comments that urged the agency to refund fees for a variety of 

other 510(k)s, including 510(k)s for transitional devices or 510(k)s that are withdrawn by 

the submitter prior to a final decision.

The agency does not agree with these comments. With the exception of products that are 

not a device or devices that are exempt from the 510(k) requirements by regulation, the 

agency will review the submission and issue a final decision. We will issue an NSE for 

a device that FDA determines to be a transitional device as well as for any device that 

will require a PMA because there is no legally marketed device.9

 The agency spends 

significant review resources to make these determinations and does not believe there is 

any basis to distinguish among NSE decisions for purposes of refunding fees. FDA 

acknowledges that the Office of Device Evaluation (ODE) annual reports that appear to 

categorize some of these decisions as “administrative” may have created confusion about 

the real nature of the review process that is associated with 510(k) review of these 

submissions. Those reports, however, were generated before FDA implemented the user 

fee legislation. The agency will modify future reports to reflect the categories discussed 

in this guidance. 

 

In addition, the agency wants to clarify that it does not review 510(k)s submitted for a 

change or modification to a legally marketed device to determine whether the change

required submission of a new 510(k). Rather, FDA reviews all 510(k)s, including those 

submitted for a change to a legally marketed device, for an equivalency determination. 

Therefore, the agency does not intend to refund user fees if, for example, a manufacturer 

later decides that the change may not have been of a type that required a new 510(k) and 

wishes to withdraw the submission. FDA encourages manufacturers who intend to 

modify a legally marketed device to consult the guidance entitled, “Deciding When to 

Submit a 510(k) for a Change to an Existing Device.”10 

FDA believes that the agency and industry should work to limit the amount of resources 

that may be expended unnecessarily on products that do not require review. The agency 

believes that those resources are better spent on reviewing applications that require and will 

benefit from FDA oversight. Therefore, we encourage all submitters first to review the 

classification regulations. The regulations identify when device types are exempt from 

510(k) requirements.11 Consultation with agency personnel before submitting 510(k)s for 

 

9

 See 21 CFR 807.92(a)(3).

10 This guidance can be found at: www.fda.gov/cdrh/ode/510kmod.html. 11 CDRH identifies the devices that are exempt from the 510(k) submission requirements by 

regulation at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm. This resource 

also explains your responsibilities with regard to devices reserved from exemption and the 

limitations to exemption.

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Contains Nonbinding Recommendations 

products that may not require review will serve to conserve both FDA and industry 

resources.12 

In addition, a manufacturer may obtain information regarding the regulatory status of its 

device or product by submitting a request under section 513(g) of the act.13 There are no 

user fees associated with such requests. 

5. Are there fees for a new submission if I previously received a not substantially 

equivalent (NSE) determination for my device? 

Any new submission for a device found NSE is subject to the fee associated with the 

submission type, if the type is subject to fees. 

If we determine your device is NSE because no predicate device exists, your device has a 

new intended use compared to the predicate, or different technological characteristics 

than the predicate that raise different questions of safety and effectiveness,14

 you may 

petition for automatic evaluation of the class III designation (de novo classification under 

section 513(f)(2)(A)) or the act),15 submit a humanitarian device exemption (HDE) 

application, or submit a PMA. De novo petitions and HDEs are not subject to user fees. 

However, if you submit a PMA, FDA will assess the PMA fee in effect at the time of 

submission.16 

We may determine that your device is NSE based on the fact that the performance data 

provided in your submission did not demonstrate your device to be as safe and effective 

as a legally marketed device. You may submit a new 510(k) if you have additional data 

showing that your device is substantially equivalent. Because we consider this 

 

12 The Division of Small Manufacturers, International, and Consumer Assistance, the 

Program Operations Staff, the review division, and product classification resources on the 

CDRH website at http://www.fda.gov/cdrh/devadvice/313.html, can help you ascertain 

whether your device is exempt by regulation.

13 For products regulated by CDRH, requests for classification information under section 

513(g) of the act should be submitted to the attention of the 513(g) Coordinator, Food and 

Drug Administration, Center for Devices and Radiological Health, 510(k) Document Mail 

Center (HFZ-401), 9200 Corporate Boulevard, Rockville, MD 20850. For products 

regulated by CBER, 513(g) requests should be submitted to the CBER Ombudsman, Center 

for Biologics Evaluations and Research, Suite 200 North, HFM-4, 1401 Rockville Pike, 

Rockville, MD 20852-1448.

14 See the guidance document entitled, FDA and Industry Actions of Premarket Notification 

(510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment at: 

www.fda/gov/cdrh/mdufma/guidance/1219.html. 15 See the guidance entitled, New Section 513(f)(2) – Evaluation of Automatic Class III 

Designation at: http://www.fda.gov/cdrh/modact/classiii.htm. 16 For fees in effect at the time of submission, see www.fda.gov/cdrh/mdufma/index.html.

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Contains Nonbinding Recommendations 

submission a new 510(k), we intend to assess the fee in effect for a 510(k) at the time of 

the new submission. 

6. Are there fees assessed if I submit additional information to a pending 510(k)? 

No. There are no fees when you submit additional information to a 510(k) for which we 

have not yet rendered a final decision. However, if you submit unsolicited additional 

information that constitutes a new indication for use or new technology, you will be 

required to submit a new 510(k) and the associated fee.17 

7. Will FDA refund the user fee if I withdraw my 510(k)?

No, FDA will not refund user fees for submissions that are withdrawn. 

The agency disagrees with comments that suggested refunds should be available when a 

submitter withdraws a 510(k). Because the statute and the goals letter establish short time 

frames for 510(k) review, it is likely that significant agency resources will already be 

expended on review at the time there is a request for withdrawal. Refunding fees in those 

circumstances would be inconsistent with the statute and would undermine the need to 

equitably distribute fees among 510(k) submitters. 

In many cases, a firm’s decision to withdraw a 510(k) is made after FDA reviewers have 

completed a cycle of review and asked for additional information. The submitter may 

decide it will not or cannot provide the additional information the agency is requesting. In 

some cases, submitters elect to withdraw a 510(k) because they believe the final agency 

decision will be an NSE. Although a submitter may request to withdraw a 510(k) at any 

time and for any reason before FDA issues a final decision, the fee will not be returned. 

The agency notes that its decision to retain fees for 510(k)s that are withdrawn is consistent 

with the provisions of MDUFMA, which anticipate the possibility that some refund may be 

appropriate for a PMA submission that is withdrawn but create no similar provision for 

510(k) withdrawals.18

8. Will FDA require a new user fee if I withdraw and resubmit my 510(k)? 

Yes. If you withdraw your 510(k) and resubmit at a later time, we plan to assess the fee in 

effect at the time of the new submission. 

 

17 See 21 CFR 807.81.

18 See section 738(a)(1)(D) of MDUFMA. 

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Contains Nonbinding Recommendations 

9. If my 510(k) is considered withdrawn because I failed to supply requested 

information, will FDA require a new user fee if I resubmit my 510(k)?

Yes. If you fail to respond to FDA’s request for additional information and we issue a 

notice of withdrawal stating that we consider your 510(k) to be withdrawn (see 21 CFR 

807.87(l)), we intend to assess the fee in effect at the time of the new submission. 

Please refer to Tables 1-3 below for a summary of fees and refunds discussed in this 

document. 

Table 1. 510(k) User Fees

510(k) Submission Type 510(k) Fee Required 

Original 510(k) Submission Yes 

510(k) Reviewed by Third Party 

• FDA-Accredited 3rd Party pursuant 

to section 523 of the act 

• EU CAB 

No 

No 

510(k) Intended Solely for a Pediatric 

Population 

No 

510(k) Submitted by State/Federal 

Government, unless Device will be 

Commercially Distributed 

No 

510(k) Submission for Device Previously 

Found NSE 

Yes 

Additional Information for Pending 510(k) No 

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Contains Nonbinding Recommendations 

8

Table 2. Refunds of 510(k) Fees

FDA Determination/Industry Action Refund of Fee 

510(k) Not Required. Basis for Decision: 

• “Not a Device” 

• “Exempt” by Regulation 

Yes 

Yes 

FDA Determines NSE. Basis for Decision: 

• No Predicate Exists 

• New Intended Use 

• Different Technology Raises 

Different Questions of Safety and 

Effectiveness 

• Lack of Performance Data 

No 

No 

No 

No 

FDA Determines that the Device is 

Intended Solely for Use in Pediatric 

Population 

Yes 

Submitter Withdraws 510(k) No 

FDA Considers Submission to be 

Withdrawn (21 CFR 807.87(l)) 

No 

Table 3. Fees for Resubmission Following NSE Determination

Submission Type Fee 

New 510(k) Yes (510(k) Fee)A

De Novo Petition (Section 513(f)(2)of the 

act) 

No 

Reclassification Petition No 

PMA Yes (PMA Fee)A 

HDE No 

A In accordance with MDUFMA, FDA will adjust the fees each year to account 

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

new fees in a Federal Register notice, no later than 60 days before the start of 

that fiscal year, see also http://www.fda.gov/cdrh/mdufma/index.html.