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  & DRUG  Food and Drug Administration  
1
Center for Devices and Radiological Health  
ADIMINISi RATION 
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, FDAs guidance documents do not establish legally enforceable  responsibilities. 
Instead, guidances describe the Agencys 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.  
1 
  Contains Nonbinding Recommendations  
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 partys 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.  
2 
  Contains Nonbinding Recommendations  
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 FDAs 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  submissions 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.  
3 
  Contains Nonbinding Recommendations  
 
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  FDAs 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   
4 
  Contains Nonbinding Recommendations  
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 FDAs 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.  
13
eSTAR 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  
5 
  Contains Nonbinding Recommendations  
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    
6 
  Contains Nonbinding Recommendations  
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  
7 
  Contains Nonbinding Recommendations  
outlined in FDAs 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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  Contains Nonbinding Recommendations  
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 FDAs 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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  Contains Nonbinding Recommendations  
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 Agencys 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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  Contains Nonbinding Recommendations  
Appendix: Information Summary Tables  
Table 1.   When is  a  510(k)  Subject  to  a  User Fee?  
510(k) Fee  
510(k)  Submission Type  
Required?  
Original 510(k) submission   Yes  
Additional information provided for existing 510(k) in response to 
No  
Refuse to Accept notification  
Additional information for a pending 510(k)   No  
510(k) submitted by a state or  federal government sponsor  and the 
No  
device will not be commercially  distributed  
510(k) eligible for review  and  reviewed by an FDA-accredited  third-
No  
party reviewer  
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?  
Will FDA Refund  
FDA Determination or Submitter Action  
My Fee Payment?  
FDA determines my  510(k) is not required.  
Basis for FDAs decision:  
   I qualify for one of the fee exceptions provided by section 
Yes  
738(a)(1)(B) of the  Act   
   My product is not a device   No  
   My device is exempt  from  premarket notification  
No  
requirements  
No  
FDA determines my  device is NSE.  
 
I  withdraw  my  510(k) after acceptance for review.   No  
FDA considers my 510(k) to be withdrawn after acceptance for 
No  
review.  See 21 CFR 807.87(m).  
I fail to submit a valid eCopy or eSTAR before  my original  
Yes  
510(k) is accepted for review.  
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)   No  
withdrawn.  
FDA determines my submission does not  meet the acceptance 
Yes  
criteria during acceptance review.  
11  Contains Nonbinding Recommendations  
Will FDA Refund  
FDA Determination or Submitter Action  
My Fee Payment?  
FDA determines my eSTAR does not pass technical screening  
Yes  
and places the submission on hold.   
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  
Yes. You must pay the applicable fee for  a De Novo.  
513(f)(2) of the Act)  
Reclassification Petition   No.  
PMA   Yes.  You must pay the applicable  fee for  a PMA.  
HDE   No.  
 
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