Contains Nonbinding Recommendations  
User Fees and Refunds for   
De Novo  Classification  Requests   
 
Guidance  for Industry and  
Food and Drug Administration Staff   
 
 
Document  issued on  October 5, 2022.  
 
Document originally issued  on  October 2,  2017.   
 
This document  supersedes  User Fees and Refunds for De Novo Classification  
Requests issued  October 5,  2021.  
 
 
 
 
 
For questions regarding submissions to the Center for Devices and Radiological Health 
(CDRH), contact the  Office of Regulatory Programs / Division of Submission Support /  
Premarket Notification (510(k)) Staff  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  
ADMINISTRATION 
Center for Devices and Radiological Health  
Center  for Biologics Evaluation and Research  
 
    Contains Nonbinding Recommendations  
Preface  
 
Public Comment  
 
You may submit  electronic 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-2017-D-5713. 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 include  the 
document number 16057 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., Bldg. 71, 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 (FAQs) ..........................................................................  2  
1.   Are all De Novo requests subject to user fees?  ...............................................................2  
2.   What are the De Novo user fees?  ....................................................................................2  
3.   How do I pay my user fee(s)?  .........................................................................................2  
4.   What are the circumstances when  FDA will refund my user fee payment?  ...................4  
5.   What are the circumstances when FDA will not refund my user fee payment?  .............4  
6.   Do I have to pay for  a new submission if I previously received a De  Novo decline  
order for my device?........................................................................................................6  
7.   If FDA considers my De  Novo request withdrawn because  I failed to supply a valid 
electronic  copy (eCopy)  or an eSTAR, will FDA  refund my fee payment?  ...................6  
8.   If acceptance criteria are not met for my De Novo  request, will FDA  refund my user  
fee payment?....................................................................................................................7  
9.   Will FDA refund the user fee if  I submit a De Novo request using eSTAR, the  
eSTAR does not pass technical screening and is placed on hold, and I withdraw the 
De Novo request?  ............................................................................................................7  
10.   Will FDA refund the user fee if  I submit an eSTAR and the eSTAR passes  technical  
screening? ........................................................................................................................8  
11.   Do I have to pay an additional fee if  I submit additional information to a pending De  
Novo request? ..................................................................................................................8  
12.   Will FDA refund the user fee if  I withdraw my De Novo request after it has been 
accepted for  review? ........................................................................................................8  
13.   Must I pay a new user fee if  I withdraw and resubmit my De Novo request  after it  
has been accepted for  review (or my eSTAR passes technical screening)? ....................8  
14.   If FDA considers my De Novo request withdrawn  after it has been accepted because 
I  failed to supply requested information, will FDA require a new user fee if  I  
resubmit my De Novo request? .......................................................................................8  
15.   If eligible, how do I request a refund?.............................................................................9  
Appendix 1    Information Summary Tables ......................................................................  10  
 
   Contains Nonbinding Recommendations  
User Fees and Refunds for  
De Novo  Classification  Requests  
 
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 De 
Novo classification  requests (De Novo  requests).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  De Novo requests  
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  also  incorporates  MDUFA V process  
improvements.  
 
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 (FAQs)  
 
1.   Are all De Novo  requests subject to user fees?  
 
Most De Novo requests are  subject to user  fees. Section 738(a)(2)(A)(xi) of the FD&C  
Act requires you to pay a user fee for  any De Novo request 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 De Novo  request  if:  
 
   your submission is for a device intended solely for a pediatric population; see  
section 738(a)(2)(B)(v)(I)  of the FD&C Act4  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  Appendix 1 for  a summary of when a De Novo request is subject to user fees  
(Table 1).  
 
2.   What are the De Novo  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.  
 
3.   How do I pay my user fee(s)?  
 
As outlined below, there  are three ways you may submit your user fee.5  Be sure to  
include the Payment Identification  Number (PIN, beginning with MD)  and  the FDA 
P.O. Box on your check, bank draft, or  U.S. Postal Money Order. A PIN is  obtained 
after  creating a User  Fee Cover Sheet and selecting Submit Cover Sheet to FDA.  
Also, you should include a 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. 
 
 
4  For guidance on the type of safety and effectiveness information  that  may be  needed to support marketing of  
pediatric devices and on protection of  pediatric subjects during the course of clinical trials involving such 
devices,  please see the guidance entitled Premarket Assessment of Pediatric Medical Devices, available at  
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/premarket-assessment-pediatric-
medical-devices.  
5  Additional information regarding payment  of user  fees is available at  
https://userfees.fda.gov/OA_HTML/mdufmaFAQ.html.  
  2  Contains Nonbinding Recommendations  
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  De Novo request. 
 
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  a phone number is also 
required for  courier delivery, use (314) 418-4013.  
 
3)   Wire Transfer:  Please include your De Novo requests 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  De Novo request  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. 
 
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  
 
  3  Contains Nonbinding Recommendations  
4.   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 De Novo  
request 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 7  and  Appendix 1 (Table 2).  
 
Withdrawal of submission if acceptance  criteria are not met: See FAQ 8  and  Appendix 
1 (Table 2).   
 
Withdrawal of an electronic submission template which did not pass technical  
screening and is placed on hold:  See FAQ 9 and Appendix 1 (Table 2).  
 
 
5.   What  are the  circumstances when  FDA will not refund my user fee  
payment?  
 
1)   Your De Novo request 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, in accordance with  21 CFR 860.230 and as  
detailed in the FDA guidance, Acceptance Review for De Novo Classification  
Requests.6  If  the De Novo request is accepted  for  review, we will not refund your  
user fee payment.  
 
2)   Your  De Novo request submitted via eSTAR has passed technical screening: When  
submitting  an electronic submission (eSubmission) using an electronic submission 
template (e.g., electronic  Submission Template And Resource (eSTAR)7,8 ), the 
refuse to accept (RTA) requirements of 21 CFR 860.230 have been automated 
within the eSTAR.9 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 De Novo  
 
6  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-review-de-novo-
classification-requests    
7  For more information see 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 eSTAR program for CDRH and CBER.  
8  eSTAR is the only type of electronic submission template that is currently available to facilitate the  
preparation of  De  Novo requests  as eSubmissions. For simplicity, the electronic submission created with this  
electronic submission template is often referred to as an eSTAR.   
9  For more information on the  RTA process, please see Acceptance Review for De Novo  Classificaiton  
Requests available at  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-
review-de-novo-classification-requests.  
  4  Contains Nonbinding Recommendations  
eSTAR. FDA intends to begin the technical screening for De Novo electronic  
submissions after confirmation of  user fee payment. If the eSTAR does not pass the  
technical screening process, FDA will notify the submitter via email10 and identify 
the inaccurate or irrelevant information, and the De Novo 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.  
 
3)   Your De Novo request  is declined:  If your De Novo request is accepted for  review  
and declined, we will not refund your  fee payment. Please note that there are 
multiple reasons for declining a De Novo request  that are identified in 21 CFR  
860.260(c), including that the product in the De Novo request is not a device under  
section 201(h) of the  FD&C  Act  and is not a combination product as defined at 21 
CFR 3.2(e) (21 CFR 860.260(c)(4)). Please see the FDA guidance document  
entitled FDA  and Industry Actions on De Novo Classification Requests: Effect on 
FDA Review Clock and Goals11 for more information. 
 
Consultation with FDA personnel before submitting De Novo  requests for products  for 
which a De Novo request is not  the appropriate  pathway  will serve to conserve both 
FDA and industry resources. Among the resources to help you ascertain whether your  
device is eligible for De  Novo classification 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.  
 
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 guidance document entitled User Fees  
for 513(g) Requests for  Information.12   
 
 
 
 
 
 
 
10  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.  
11  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-and-industry-actions-de-
novo-classification-requests-effect-fda-review-clock-and-goals    
12  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/user-fees-513g-requests-
information    
  5  Contains Nonbinding Recommendations  
6.   Do I have to pay for a new submission if I previously received a De  
Novo  decline  order  for my device?  
 
Yes, unless a statutory exception applies. Any new submission for a device  for which a  
previous  De Novo  request was issued a decline order is subject to the fee associated  
with the  submission type, if the type is subject to fees.13  
 
If we decline your  De Novo request for  any of the  reasons  set forth  in 21 CFR  
860.260(c),14  it  may  be appropriate to  submit a different type of marketing application 
for the product that was the subject of the request, such as a  premarket notification  
(510(k)), a humanitarian device exemption (HDE) application, or a premarket  approval  
application (PMA).  HDEs are not subject to user fees.15 However, if you submit a  
510(k) or  PMA, FDA will assess the  510(k) or  PMA fee in  effect at the time of  
submission (https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-
fee-amendments-mdufa).  
 
You may also  submit a new  De Novo  request if you believe you have additional  
information, including performance  data, demonstrating that either general  controls  
alone, or general  and special controls, provide reasonable assurance of safety and 
effectiveness  for the device. Because  FDA considers this submission a new  De Novo  
request, we will  assess the fee in  effect for  a De Novo  request  at the time of the new  De 
Novo request. This information is summarized in  Appendix 1 (Table 3).  
 
7.   If FDA considers my  De Novo  request  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.  As outlined in FDAs guidance  eCopy Program for Medical Device  
Submissions,16 if FDA does not receive an eCopy, or 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 Agency considers a De Novo request to be  
withdrawn. A notice of  withdrawal in these circumstances is sometimes referred to as a 
deletion letter. The term deletion is used to differentiate withdrawal due to a lack  
of timely response (21 CFR 860.250(a)(1)-(2)) from a request to withdraw a pending 
 
13  Section 738(a)(2)(A) of the FD&C Act.    
14  For more information, see FDAs guidance entitled, FDA and Industry Actions on De Novo Classification  
Requests: Effect on FDA Review Clock and Goals  available at  https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/fda-and-industry-actions-de-novo-classification-requests-effect-
fda-review-clock-and-goals.  
15  Section 738(a)(2)(B)(i) of the FD&C Act.   
16  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ecopy-program-medical-device-
submissions    
  6  Contains Nonbinding Recommendations  
De Novo request  submitted  by the requester (21 CFR 860.250(a)(4)). If the  De Novo 
request is withdrawn (deleted)  in this manner, 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 also  send  a written  
request to withdraw your submission (see 21 CFR 860.250(a)(4)) 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.17 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  De Novo  
request has been accepted for review  (see  FAQ 14 and Appendix 1 (Table 2)).  
 
8.   If acceptance criteria are not met for my  De Novo request, will FDA  
refund my user fee  payment?  
 
Yes. FDA intends to conduct an acceptance review18 of your submission in accordance 
with  21 CFR 860.230 and as detailed in the FDA  guidance, Acceptance Review for  
De Novo Classification Requests.19  If FDA refuses  to accept  your submission, you 
will be notified within 15  calendar  days of  receipt that your submission has not been 
accepted (21 CFR 860.230(a) and 21 CFR 860.230(c)). You may submit additional  
information to the De Novo request to address the  reasons for the refusal without  
submitting a new user fee. Alternatively, you may send a written request to withdraw  
the submission (see 21 CFR 860.250(a)(4))  and request a refund of the fee  paid if you 
decide not to provide additional information. See FAQ 15 below  for more information 
on how to request a  refund. 
 
9.   Will FDA refund the user fee if  I submit a  De Novo request  using  
eSTAR, the eSTAR does not pass technical screening and is placed on  
hold,  and I withdraw the De Novo request?  
 
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 De Novo request to address the reasons for  the technical screening hold without  
submitting a new user fee. Alternatively, you may send a written request to withdraw  
the submission (see 21 CFR 860.250(a)(4))  and request a refund of the fee  paid if you 
decide not to provide additional information. Additionally, Section V, Question 5 of  
FDAs guidance Acceptance Review for  De Novo Classification Requests20 explains  
that FDA may refuse to accept a  De Novo request, if, on its face, the De Novo request  
is ineligible for De Novo classification due to the  existence of  a legally marketed  
predicate,  an existing classification regulation exists for the same device type, or an 
 
17  https://www.fda.gov/medical-devices/how-study-and-market-your-device/voluntary-estar-program  
18  As stated above in FAQ5, for  De Novo requests  submitted  using eSTAR,  RTA  requirements of 21 CFR  
860.230 have been automated within the eSTAR.    
19  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-review-de-novo-
classification-requests    
20  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-review-de-novo-
classification-requests   
  7  Contains Nonbinding Recommendations  
approved PMA(s)  exists for the same device type. For eSTARs, FDA intends to refund 
user fee payments, upon request, for  an eSTAR that FDA determines to be  ineligible on 
its face for the same  reasons as outlined above. In such instances,  FDA will use the 
technical screening process to place the eSTAR on hold within 15 calendar  days of  
eSTAR receipt. The requester may then request withdrawal of the eSTAR  and request a  
refund.  
 
10.   Will FDA refund the user fee if  I submit an eSTAR  and the  eSTAR  
passes technical screening?  
 
No. The RTA requirements of 21 CFR 860.230 have been automated within eSTAR, 
and therefore, FDA  will consider a De Novo eSTAR that passes the technical screening  
process to have fulfilled the acceptance review requirements.  As such, we  will not 
refund user fees paid for  eSTARs that have passed technical screening.  
 
11.   Do I have to pay an  additional fee  if  I submit additional information  
to a pending De Novo  request?  
 
No. There  are no fees when you submit additional information to a  De Novo  request  
for which FDA has not yet rendered a  final decision.  
 
12.   Will FDA refund the user fee if  I withdraw my  De Novo  request  after 
it has been  accepted for review?  
 
No. The FD&C Act does not identify withdrawal  of a De  Novo request  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 supplement21  is withdrawn  after  
filing,22  that authority does not extend to De Novo  requests.  
 
13.   Must I pay a new user fee if  I withdraw  and resubmit my  De Novo  
request  after it has been accepted for review  (or my eSTAR passes 
technical screening)?  
 
Yes. If you withdraw your  De Novo  request  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  De Novo request.  
 
14.   If FDA considers my De Novo  request  withdrawn  after it has been  
accepted  because I failed to supply requested  information, will FDA 
require a new user fee if I resubmit my  De Novo  request?  
 
 
21  These terms are defined by sections  737(1), 737(2),  and 737(4)(A),  of the FD&C Act.  
22  See section 738(a)(2)(D)(iii) of the FD&C Act.  
  8  Contains Nonbinding Recommendations  
Yes. If you fail to respond to an FDA  request for additional information pursuant to 21 
CFR 860.240(b)(1)  (i.e., a supplement or amendment to revise existing information or  
provide additional information), FDA will issue  a notice of withdrawal  (deletion letter)  
stating that it considers your  De Novo  request  to be withdrawn (21 CFR  
860.250(a)(1)). You must pay the  De Novo  fee in  effect at the time of the new  De 
Novo  request.  
 
15.   If eligible, how do I request a refund?  
 
To  facilitate  the Agencys orderly issuance of refunds, you should submit a written  
request23  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.  
 
 
 
 
 
 
 
 
 
 
 
   
 
23  The user fee payment refund request form is available at  https://www.fda.gov/media/96650/download  
  9  Contains Nonbinding Recommendations  
Appendix 1   Information  Summary Tables 
 
 
Table  1. When Is a De  Novo Request Subject to a User Fee?  
 
De Novo  Fee  
De Novo  Request  Submission  Type  
Required  
Original De Novo  request   Yes  
Additional information for a De  Novo request that has not yet  
No  
been accepted  
Additional information for a pending De Novo  request   No  
De Novo  request submitted by a state or  federal government  
No  
sponsor, and  the device  will not be commercially distributed  
De Novo  request intended solely for a pediatric population   No  
De Novo  request for  a device for which the previous  De Novo  
Yes  
request was declined  
De Novo resubmitted after it has been withdrawn   Yes  
 
 
Table  2. When Will  FDA Refund a  De Novo  User Fee?  
 
Will FDA Refund   
FDA Determination or Submitter Action  
My Fee Payment?  
I qualify for one of the  fee exceptions  provided by section 
Yes  
738(a)(2)(B) of the  FD&C  Act.  
FDA declines  my De Novo  request.   No  
I  withdraw my De Novo  request  after acceptance for review.   No  
FDA considers my De Novo  request  to be withdrawn  after  
No  
acceptance for review.  
I fail to submit a  valid  eCopy  or eSTAR  before my Original  
Yes   
De Novo request  is accepted for  review.  
I  fail to submit a valid eCopy or eSTAR  for a  De Novo  
amendment or supplement and FDA  considers the De Novo  No  
request withdrawn.  
FDA determines my  De  Novo request  does not meet the  
Yes  
acceptance criteria during acceptance review.  
FDA determines my eSTAR is incomplete and places the 
Yes  
submission on hold.  
I  withdraw my eSTAR after it passes technical screening.   No  
 
 
 
 
 
  10   Contains Nonbinding Recommendations  
Table  3. What Fee Must  I Pay  for  a New  Device  Submission  Following a De  
Novo  Decline Determination?  
 
Submission Type   Must I Pay a Fee?  
New  De Novo  request   Yes. You must pay the applicable fee for  a  De Novo  request.  
510(k)   Yes. You must pay the applicable fee for  a  510(k).  
Reclassification  petition   No  
PMA   Yes. You must pay the applicable fee for  a PMA.  
HDE   No  
 
  11