User Fees and Refunds for Premarket Notification Submissions (510(k)s): Guidance for Industry and Food and Drug Administration Staff

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

. FOOD & DRU1
G
ADIMINIS i RATION
Contains Nonbinding Recommendations
User Fees and Refunds for Premarket
Notification Submissions (510(k)s)
Guidance for Industry and
Food and Drug Administration Staff
Document issued on October 5, 2022.
Document originally issued on May 28, 2004.
This document supersedes “User Fees and Refunds for Premarket
Notification Submissions (510(k)s)” issued on October 2, 2017.
For questions regarding submissions to the Center for Devices and Radiological Health (CDRH),
contact the Office of Regulatory Programs / Division of Submission Support / 510(k), De Novo,
513(g), Device Determinations and Custom Devices Lifecycle Team at 301-796-5640, or by
email at OPEQSubmissionSupport@fda.hhs.gov.
For questions regarding submissions to the Center for Biologics Evaluation and Research
(CBER), contact the Office of Communication, Outreach, and Development (OCOD) at 1-800-
835-4709 or 240-402-8010, or by email at ocod@fda.hhs.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
You may submit written comments and suggestions at any time for Agency consideration to
https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852-
1740. Identify all comments with the docket number FDA-2003-D-0198. Comments may not be
acted upon by the Agency until the document is next revised or updated.
Additional Copies
CDRH
Additional copies are available from the Internet. You may also send an e-mail request to
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please use the document
number 1511 and complete title of the guidance in the request.
CBER
Additional copies are available from the Center for Biologics Evaluation and Research (CBER),
Office of Communication, Outreach, and Development (OCOD), 10903 New Hampshire Ave.,
WO71, Room 3128, Silver Spring, MD 20993-0002, or by calling 1-800-835-4709 or 240-402-
8010, by email, ocod@fda.hhs.gov, or from the Internet at https://www.fda.gov/vaccines-blood-
biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances.

Contains Nonbinding Recommendations
Table of Contents
I. 	Introduction.......................................................................................................................1
II. 	Frequently Asked Questions (FAQ) .................................................................................2
1. 	Are all 510(k)s subject to user fees? ..............................................................................2
2. 	What are the 510(k) user fees? ......................................................................................2
3. 	How do I pay my user fee(s)? ........................................................................................3
4. 	If FDA has indicated that my device is eligible for third-party review, and my 510(k) was
reviewed by a third party, but FDA later determines that my device is not eligible for
review by the third party, will I have to pay a user fee?.................................................4
5. 	If my 510(k) was reviewed by a third party, will I have to pay a user fee if my device
was not eligible for review by the third party?...............................................................4
6. 	What are the circumstances when FDA will refund my user fee payment?..................5
7. 	What are the circumstances when FDA will not refund my user fee payment?............5
8. 	Do I have to pay for a new submission if I previously received a Not Substantially
Equivalent (NSE) determination for my device? ...........................................................6
9. 	If FDA considers my 510(k) withdrawn because I failed to supply a valid electronic
copy (eCopy) or an eSTAR, will FDA refund my fee payment? ..................................7
10. If acceptance criteria are not met for my 510(k) submission, will FDA refund my user
fee payment? ..................................................................................................................8
11. Will FDA refund the user fee if I submit a 510(k) using eSTAR, the eSTAR does not
pass technical screening and is placed on hold, and I withdraw the 510(k)
submission?....................................................................................................................8
12. Will FDA refund the user fee if I submit an eSTAR and the eSTAR passes technical
screening? ......................................................................................................................9
13. Do I have to pay an additional fee if I submit additional information to a pending
510(k)? ...........................................................................................................................9
14. Will FDA refund the user fee if I withdraw my 510(k) after it has been accepted for
review?...........................................................................................................................9
15. Must I pay a new user fee if I withdraw and resubmit my 510(k) after it has been
accepted for review (or my eSTAR passes technical screening)? ...............................10
16. If FDA considers my 510(k) withdrawn after it has been accepted because I failed to
supply requested information, will FDA require a new user fee if I resubmit my
510(k)? .........................................................................................................................10
17. If eligible, how do I request a refund? .........................................................................10
Appendix: Information Summary Tables ................................................................................11
Table 1. When is a 510(k) Subject to a User Fee? ............................................................11
Table 2. When Will FDA Refund a 510(k) User Fee? .......................................................11
Table 3. What Fee Must I Pay for a New Device Submission Following a 510(k) “NSE”
Determination?.............................................................................................................12

Contains Nonbinding Recommendations
User Fees and Refunds for
Premarket Notification Submissions
(510(k)s)
Guidance for Industry and Food and
Drug Administration Staff
This guidance represents the current thinking of the Food and Drug Administration (FDA
or Agency) on this topic. It does not establish any rights for any person and is not binding
on FDA or the public. You can use an alternative approach if it satisfies the requirements
of the applicable statutes and regulations. To discuss an alternative approach, contact the
FDA staff or Office responsible for this guidance as listed on the title page.
I. 	Introduction
The Medical Device User Fee Amendments of 20221 (MDUFA V), amended the Federal
Food, Drug, and Cosmetic Act (FD&C Act) to authorize FDA to collect user fees for the
review of certain premarket submissions received on or after October 1, 2022, including
premarket notification submissions (510(k)s).2 The additional funds obtained from user fees
will enable FDA, with the cooperation of industry, to improve the medical device review
process to meet certain performance goals and implement improvements for the medical
device review process as outlined in the letter from the Secretary of Health and Human
Services to Congress.3
The purpose of this guidance document is to identify: (1) the types of 510(k)s subject to user
fees, (2) exceptions to user fees, and (3) the actions that may result in refunds of user fees
that have been paid. This document incorporates the impact of process improvements from
MDUFA V.
In general, FDA’s guidance documents 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
1 See Title II of the FDA User Fee Reauthorization Act of 2022 (Public Law 117-180).
2 For additional information on medical device user fees, please see https://www.fda.gov/industry/fda-user-fee-
programs/medical-device-user-fee-amendments-mdufa.
3 See 168 CONG. REC. S5194-S5203 (daily ed. September 28, 2022) (Food and Drug Administration User Fee
Reauthorization). The MDUFA V Commitment Letter is also available at
https://www.fda.gov/media/158308/download.
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use of the word should in Agency guidances means that something is suggested or
recommended, but not required.
II. 	Frequently Asked Questions (FAQ)
1. 	Are all 510(k)s subject to user fees?
Most 510(k) submissions are subject to user fees. Section 738(a)(2)(A)(viii) of the FD&C
Act, requires the submitter to pay a user fee for any 510(k) (Traditional, Abbreviated, or
Special4) that you submit to FDA, unless you qualify for one of the exceptions listed below.
You will not have to pay a user fee for your 510(k) if:
• 	your submission is reviewed by an FDA-accredited third party5 who submits it to
FDA with the third party’s recommendation concerning whether your device is
substantially equivalent to a legally-marketed predicate; see section 738(a)(2)(B)(iv)
of the FD&C Act; or
• 	your submission is for a device intended solely for a pediatric population; see section
738(a)(2)(B)(v)(I) of the FD&C Act;6 or
• 	you are a state or federal government entity and your device will not be distributed
commercially; see section 738(a)(2)(B)(iii) of the FD&C Act.
Refer to the Appendix for a summary of when a 510(k) is subject to user fees (Table 1).
2. 	What are the 510(k) user fees?
User fees for the current fiscal year are established under section 738 of the FD&C Act and
shown on the FDA MDUFA User Fees website at https://www.fda.gov/industry/fda-user-fee-
programs/medical-device-user-fee-amendments-mdufa.
4 These terms are explained in “The 510(k) Program: Evaluating Substantial Equivalence in Premarket
Notifications [510(k)],” available at https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/510k-program-evaluating-substantial-equivalence-premarket-notifications-510k, “The Abbreviated
510(k) Program,” available at https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/abbreviated-510k-program, or “The Special 510(k) Program,” available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/special-510k-program,
respectively.
5 See section 523 of the FD&C Act. For general information concerning third-party review of 510(k)s, see
“510(k) Third Party Review Program,” available at https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/510k-third-party-review-program .
6 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 “Premarket Assessment of Pediatric Medical Devices,” available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/premarket-assessment-
pediatric-medical-devices.
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3. 	How do I pay my user fee(s)?
As outlined below, there are three ways you may submit your user fee.7 Be sure to include
the Payment Identification Number (PIN, beginning with MD)8 and the FDA P.O. Box on
your check, bank draft, or U.S. Postal Money Order. Also, you should include a printed copy
of your User Fee Cover Sheet (Form FDA 3601, accessible through FDA’s User Fee System
at https://userfees.fda.gov/OA_HTML/fdaCAcdLogin.jsp) with your payment.
1) 	Preferred method – Credit Card or Electronic Check (ACH): FDA has partnered with the
U.S. Department of the Treasury to utilize https://www.pay.gov/, a Web-based payment
system, for online electronic payment. You may make a payment via electronic check or
credit card after submitting your cover sheet. To pay online, select the “Pay Now” button.
Credit card transactions for cover sheets are limited to $24,999.99.
2) 	Check: All paper checks must be in U.S. currency from a U.S. bank and made payable to
the Food and Drug Administration. Please write your unique PIN, from the upper right-
hand corner of your completed Medical Device User Fee cover sheet, on the check and
mail the check to the appropriate address listed below. FDA will not be able to process
your payment correctly without your cover sheet PIN.
Check payments by mail:
Food and Drug Administration
P.O. Box 979033
St. Louis, MO 63197-9000
Note: In no case should payment be submitted with the 510(k).
Check payments delivered by a courier service:
U.S. Bank
ATTN: Government Lockbox 979033
1005 Convention Plaza
St. Louis, MO 63101
Note: This address is for courier delivery only. If you have any questions concerning
courier delivery, contact US Bank at (314) 418-4013.
3) 	Wire Transfer: Please include your submission’s unique PIN, from the upper right-hand
corner of your completed Medical Device User Fee cover sheet, in your wire transfer.
Without the PIN your payment may not be applied to your cover sheet and review of your
submission will be delayed.
The originating financial institution may charge a wire transfer fee. Please ask your
financial institution about the fee and include it with your payment to ensure that your
cover sheet is fully paid.
7 Additional information regarding payment of user fees is available at
https://userfees.fda.gov/OA_HTML/mdufmaFAQ.html.
8 A PIN is obtained after creating a User Fee Cover Sheet and selecting “Submit Cover Sheet to FDA.”
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Wire transfer information:
US Department of Treasury
TREAS NYC
33 Liberty Street
New York, NY 10045
FDA Deposit Account Number: 75060099
US Department of Treasury routing/transit number: 021030004
SWIFT Number: FRNYUS33
4. 	If FDA has indicated that my device is eligible for third-party
review, and my 510(k) was reviewed by a third party, but
FDA later determines that my device is not eligible for
review by the third party, will I have to pay a user fee?
No. You do not have to pay a user fee if FDA had indicated your device is eligible for third-
party review but determines during the course of review of the third-party submission that
your device is not appropriate for third-party review. Among the reasons FDA may later
determine that a particular device is not appropriate for third-party review are:9
• 	The device requires clinical data to demonstrate substantial equivalence; see section
523(a)(3)(A)(iii) of the Act.
• 	The device or combination product requires multi-Center review or consultation (e.g.,
510(k)s for drug/device combination products).
5. 	If my 510(k) was reviewed by a third party, will I have to
pay a user fee if my device was not eligible for review by the
third party?
Yes. If you employ a third-party reviewer to review a device that is not eligible for third-
party review, the exception is not applicable and you will have to pay the appropriate 510(k)
user fee in effect for your submission.
Please refer to FDA’s guidance 510(k) Third Party Review Program10 for a list of factors
used in determining device type eligibility for the third-party review program.
9 Each third-party review of a 510(k) must meet the statutory eligibility requirements set out in section 523 of
the Act. The two criteria identified here are the two most likely to be subject to errors of interpretation.
10 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-third-party-review-
program
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6. 	What are the circumstances when FDA will refund my user
fee payment?
Statutory exception: If we determine that you have mistakenly paid a fee for a type of 510(k)
that does not require a fee because of a statutory exception (see FAQ 1 and Appendix 1
(Table 1)), FDA will refund your payment for that submission upon request.
Failure to supply a valid electronic copy (eCopy) or an electronic submission template: See
FAQ 9 and Appendix 1 (Table 2).
Withdrawal of submission if acceptance criteria are not met: See FAQ 10 and Appendix 1
(Table 2).
Withdrawal of an electronic submission template which did not pass technical screening and
is placed on hold: See FAQ 11 and Appendix 1 (Table 2).
7. 	What are the circumstances when FDA will not refund my
user fee payment?
4) 	Your 510(k) submission is accepted for review: After the user fee is paid and a
valid eCopy is provided to FDA, FDA intends to conduct an acceptance review of
your submission within 15 calendar days, as detailed in the FDA guidance,
“Refuse to Accept Policy for 510(k)s.”11 If the 510(k) submission is accepted for
review, we will not refund your user fee payment.
5) 	Your 510(k) submitted via eSTAR has passed technical screening: After the user
fee is paid for a 510(k) submitted via the electronic Submission Template And
Resource (eSTAR),12,13 FDA intends to conduct a virus screening and technical
screening of your submission within 15 calendar days, as detailed in the FDA
guidance “Electronic Submission Template for Medical Device 510(k)
Submissions.”14 If the 510(k) submission passes the technical screening process,
we will not refund your user fee payment.
11 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/refuse-accept-policy-510ks
12 For more information see FDA guidance “Electronic Submission Template for Medical Device 510(k)
Submissions,” available at https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/electronic-submission-template-medical-device-510k-submissions, and FDA’s website regarding the
eSTAR program (https://www.fda.gov/medical-devices/how-study-and-market-your-device/voluntary-estar-
program). This website provides current information regarding the eSTAR program for CDRH and CBER.
13eSTAR is the only type of electronic submission template that is currently available to facilitate the
preparation of 510(k) submissions as eSubmissions. For simplicity, the electronic submission created with this
electronic submission template is often referred to as an “eSTAR.”
14 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-
submission-template-medical-device-510k-submissions
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6) 	Device is exempt from 510(k) requirements of the Act: If you submit a 510(k) for a device
that is exempt from the requirements of section 510(k) of the FD&C Act, we will not
refund your fee payment. It is your responsibility to review the classification
regulations15 that pertain to your device and to determine whether a regulation exempts
your device from the 510(k) requirements. Consultation with FDA personnel before
submitting 510(k)s for products that may not require review will serve to conserve both
FDA and industry resources.16
7) 	Not a device: If you submit a 510(k) for a product that FDA determines does not meet
the definition of a device under section 201(h) of the FD&C Act, or is not a combination
product with a device constituent part, we will not refund your fee payment.
8) 	Change or modification to a device: FDA reviews all 510(k) submissions, including
those for a change to a legally marketed device, for determination of substantial
equivalence. 17 Therefore, FDA 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 FDA guidance, “Deciding
When to Submit a 510(k) for a Change to an Existing Device.”18 Also, note that a
guidance document applicable to a specific type of device would supersede the above
referenced general guidance document.
In addition, in order to obtain information regarding the class in which a device has been
classified or the requirements applicable to a device, a manufacturer may submit a request
under section 513(g) of the FD&C Act. For more information on submitting a 513(g)
Request for Information, please see the FDA guidance “User Fees for 513(g) Requests for
Information.”19
8. 	Do I have to pay for a new submission if I previously
received a Not Substantially Equivalent (NSE)
determination for my device?
Yes, unless a statutory exception applies. Any new submission for a device found NSE is
15 See 21 CFR parts 862-892.
16 Among the resources to help you ascertain whether your device is exempt by regulation are the Division of
Industry and Consumer Education (DICE) for CDRH and the Manufacturers Assistance and Technical Training
Branch (MATTB) for CBER, the CDRH or CBER review staff; and product classification resources on the
CDRH website, available at https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-
medical-device. DICE can be reached by phone at (800) 638-2041 or (301) 796-7100, or by email at
DICE@fda.hhs.gov. MATTB can be reached at (800) 835-4709 or (240) 402 8020, or by email at
Industry.Biologics@fda.hhs.gov.
17 See 21 CFR 807.81.
18 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-
change-existing-device
19 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/user-fees-513g-requests-
information
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subject to the fee associated with the submission type, if the type is subject to fees.20
As described in the FDA guidance, “FDA and Industry Actions on Premarket Notification
(510(k)) Submissions: Effect on FDA Review Clock and Goals,”21 if we determine your
device is NSE for one of the following three reasons:
• 	no predicate device, as defined in 21 CFR 807.92(a)(3), exists,
• 	your device has a new intended use compared to the predicate, or
• 	your device has different technological characteristics that raise different questions of
safety and effectiveness;22
You have three options: (1) You may petition for Evaluation of Automatic Class III
Designation (De Novo classification request under section 513(f)(2)(A) of the FD&C Act,
(2) submit a humanitarian device exemption (HDE) application, or (3) submit a premarket
approval application (PMA), 	HDEs are not subject to user fees.23 However, if you submit a
PMA or De Novo request, FDA will assess the PMA or De Novo user fee at the time of the
submission (https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-
amendments-mdufa).
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 at least as safe and
effective as a legally marketed device of that type. You may submit a new 510(k) if you
believe you have additional data showing that your device is substantially equivalent to a
legally marketed predicate device. Because FDA considers this submission a new 510(k), we
will assess the fee in effect for a 510(k) at the time of the new 510(k) submission. This
information is summarized in the Appendix (Table 3).
9. 	If FDA considers my 510(k) withdrawn because I failed to
supply a valid electronic copy (eCopy) or an eSTAR, will
FDA refund my fee payment?
Yes. Section 745A(b) of the FD&C Act provides statutory authority to require eCopies or
submission solely in electronic format (e.g., eSTAR) after issuance of final guidance.24 As
20 Section 738(a)(2)(A) of the FD&C Act.
21 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-and-industry-actions-
premarket-notification-510k-submissions-effect-fda-review-clock-and-goals
22 See section 513(i) of the FD&C Act
23 Section 738(a)(2)(B)(i) of the FD&C Act.
24 See Providing Regulatory Submissions for Medical Devices in Electronic Format - Submissions Under
Section 745A(b) of the Federal Food, Drug, and Cosmetic Act, available at https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/fda-and-industry-actions-premarket-notification-510k-
submissions-effect-fda-review-clock-and-goals
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outlined in FDA’s guidance “eCopy Program for Medical Device Submissions,”25 if FDA
receives an eCopy that cannot be accepted because it does not meet our technical standards,
the omission or reasons for that failure will be communicated to you in writing to aid in your
creation of a valid replacement eCopy. If a valid eCopy of an original submission is not
received within 180 calendar days of this notification, the submission will be deleted from
our system and FDA will refund the fee paid upon request. If you decide not to submit a
valid replacement eCopy of your original submission in response to the eCopy hold
notification, you may send a written request to withdraw your submission before receiving a
deletion letter and request a refund of the fee paid. FDA intends to follow a similar process
should an eSTAR be submitted that does not pass an automatic verification process.26
Note that your fee will not be refunded if you fail to provide a valid eCopy or an eSTAR for
a response to an additional information request after the 510(k) has been accepted for review
(see FAQ 16 and Appendix 1 (Table 2)).
10. 	If acceptance criteria are not met for my 510(k) submission,
will FDA refund my user fee payment?
Yes. FDA intends to conduct an acceptance review of your submission as detailed in the
FDA guidance, “Refuse to Accept Policy for 510(k)s.”27 If FDA refuses to accept your
submission, you will be notified within 15 calendar days of receipt that your submission has
not been accepted. You may submit additional information to the 510(k) submission to
address the reasons for the refusal without submitting a new user fee. Alternatively, you may
request to withdraw the submission and request a refund of the fee paid if you decide not to
provide additional information. See FAQ 17 below for more information on how to request a
refund.
11. 	Will FDA refund the user fee if I submit a 510(k) using
eSTAR, the eSTAR does not pass technical screening and is
placed on hold, and I withdraw the 510(k) submission?
Yes. You will be notified within 15 calendar days of receipt if your eSTAR does not pass
technical screening and is placed on hold. You may submit additional information to the
510(k) submission to address the reasons for the technical screening hold without submitting
a new user fee. Alternatively, you may request to withdraw the submission and request a
refund of the fee paid if you decide not to provide additional information.
25 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ecopy-program-medical-device-
submissions
26 https://www.fda.gov/medical-devices/how-study-and-market-your-device/voluntary-estar-program
27 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/refuse-accept-policy-510ks
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12. 	Will FDA refund the user fee if I submit an eSTAR and the
eSTAR passes technical screening?
No. Given that an electronic submission properly prepared with an electronic submission
template (e.g., eSTAR)) should represent a complete submission,28 eSTARs are not
anticipated to undergo a refuse to accept (RTA) process.29 However, FDA intends to employ
a virus scanning and technical screening process for an eSTAR. The technical screening
process is anticipated to occur within 15 calendar days of FDA receiving the 510(k) eSTAR.
FDA intends to begin the technical screening for 510(k) electronic submissions after
confirmation of user fee payment. If the eSTAR is not complete when submitted, FDA will
notify the submitter via email30 and identify the incomplete information, and the 510(k) will
be placed and remain on hold until a complete replacement eSTAR is submitted to FDA.
FDA will not refund user fees paid for eSTARs that have passed technical screening.
13. 	Do I have to pay an additional fee 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 FDA
has not yet rendered a final decision. However, if you submit unsolicited additional
information that constitutes a new indication for use or new or different technology, (i.e.,
changes that would typically require submission of a new 510(k)),31 you will be required to
submit a new 510(k) and pay the associated fee.
14. 	Will FDA refund the user fee if I withdraw my 510(k) after
it has been accepted for review?
No. The FD&C Act does not identify withdrawal of a 510(k) submission under substantive
review as a basis for a refund; see section 738(a)(2)(D) of the FD&C Act. Although the
FD&C Act provides FDA limited authority to provide a partial refund when a premarket
application, premarket report, or supplement 32 is withdrawn after filing,33 that authority
does not extend to 510(k) submissions.
28 After a submitter completes all necessary sections in their eSTAR file correctly, the status message at the top
of the PDF will indicate “eSTAR Complete” to represent a complete submission.
29 For more information on the RTA process, please see “Refuse to Accept Policy for 510(k)s,” available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/refuse-accept-policy-510ks.
30 For additional information about email communications with CBER, please see the “SOPP 8119: Use of
Email for Regulatory Communications,” available at https://www.fda.gov/media/108992/download.
31 See FDA’s guidance Deciding When to Submit a 510(k) for a Change to an Existing Device, available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-
change-existing-device
32 These terms are defined by sections 737(1), 737(2), and 737(4)(A), respectively, of the FD&C Act.
33 See section 738(a)(2)(D)(iii) of the FD&C Act.
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15. 	Must I pay a new user fee if I withdraw and resubmit my
510(k) after it has been accepted for review (or my eSTAR
passes technical screening)?
Yes. If you withdraw your 510(k) submission after it has been accepted for review (or, for an
eSTAR, after it passes technical screening), and resubmit at a later time, you must pay the fee
in effect at the time of the new submission.
16. 	If FDA considers my 510(k) withdrawn after it has been
accepted 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 an FDA request for additional information within the specified
timeframe, FDA will issue a notice of withdrawal stating that it considers your 510(k) to be
withdrawn.34 You must pay the 510(k) fee in effect at the time of the new 510(k) submission.
17. 	If eligible, how do I request a refund?
To facilitate the Agency’s orderly issuance of refunds, you should submit a written request35
for a refund to the appropriate Center in FDA within 180 calendar days after the fee was due.
For devices regulated by CDRH, requests for refunds should be submitted to the current
mailing address displayed on the website https://www.fda.gov/cdrhsubmissionaddress.
For devices regulated by CBER, requests for refunds should be submitted to the current
mailing address displayed on the website https://www.fda.gov/about-fda/center-biologics-
evaluation-and-research-cber/regulatory-submissions-electronic-and-paper.
34 See 21 CFR 807.87(m) and FDA and Industry Actions on Premarket Notification (510(k)) Submissions:
Effect on FDA Review Clock and Goals, available at https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/fda-and-industry-actions-premarket-notification-510k-submissions-effect-fda-review-
clock-and-goals
35 The user fee payment refund request form is available at https://www.fda.gov/media/96650/download.
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Appendix: Information Summary Tables
Table 1. When is a 510(k) Subject to a User Fee?
510(k) Submission Type 510(k) Fee
Required?
Original 510(k) submission 	Yes
Additional information provided for existing 510(k) in response to
Refuse to Accept notification No
Additional information for a pending 510(k) 	No
510(k) submitted by a state or federal government sponsor and the
device will not be commercially distributed No
510(k) eligible for review and reviewed by an FDA-accredited third-
party reviewer No
510(k) intended solely for a pediatric population 	No
510(k) submission for a device previously found NSE 	Yes
510(k) resubmitted after it has been withdrawn 	Yes
Table 2. When Will FDA Refund a 510(k) User Fee?
FDA Determination or Submitter Action Will FDA Refund
My Fee Payment?
FDA determines my 510(k) is not required.
Basis for FDA’s decision:
• 	I qualify for one of the fee exceptions provided by section
738(a)(1)(B) of the Act Yes
• 	My product is not a device 	No
• 	My device is exempt from premarket notification
requirements No
FDA determines my device is “NSE.” No
I withdraw my 510(k) after acceptance for review. 	No
FDA considers my 510(k) to be withdrawn after acceptance for
review. See 21 CFR 807.87(m). No
I fail to submit a valid eCopy or eSTAR before my original
510(k) is accepted for review. Yes
I fail to submit a valid eCopy or eSTAR for a 510(k) response to
an additional information request and FDA considers the 510(k)
withdrawn.
No
FDA determines my submission does not meet the acceptance
criteria during acceptance review. Yes
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Contains Nonbinding Recommendations
FDA Determination or Submitter Action Will FDA Refund
My Fee Payment?
FDA determines my eSTAR does not pass technical screening
and places the submission on hold. Yes
I withdraw my eSTAR after it passes technical screening. 	No
Table 3. What Fee Must I Pay for a New Device Submission
Following a 510(k) “NSE” Determination?
Submission Type 	Must I Pay a Fee?
New 510(k) 	Yes. You must pay the applicable fee for a 510(k).
De Novo Request (see section
513(f)(2) of the Act) Yes. You must pay the applicable fee for a De Novo.
Reclassification Petition 	No.
PMA 	Yes. You must pay the applicable fee for a PMA.
HDE 	No.
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