Contains Nonbinding Recommendations 
User Fees and Refunds for Premarket 
Approval Applications and Device  
Biologics License Applications 
Guidance for Industry and 
Food and Drug Administration Staff 
Document issued on October 5, 2022. 
Document originally issued on April 2, 2013. 
This document supersedes User Fees and Refunds for Premarket Approval 
Applications and Device Biologics License Applications  
issued December 12, 2018.  
For questions regarding submissions to the Center for Devices and Radiological Health (CDRH), 
contact the Office of Regulatory Programs / Division of Submission Support / PMA, HDE, Q-
Submission, and Device Tracking 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 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 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-2009-D-0051. 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 1681 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.  Types of PMA Applications Subject to User Fees .................................................................2 
A.  Original PMAs ..................................................................................................................2 
B.  Modular PMAs..................................................................................................................2 
C.  Premarket Reports .............................................................................................................3 
D.  Licensing Agreement PMAs .............................................................................................3 
E.  Panel-Track Supplements .................................................................................................3 
F.  180-Day Supplements .......................................................................................................4 
G.  Real-Time Supplements ....................................................................................................4 
H.  30-Day Notices .................................................................................................................4 
I.  Periodic Reports ................................................................................................................5 
III.  Types of Biologics License Applications Subject to Device User Fees .................................6 
A.  Original BLAs ...................................................................................................................6 
B.  BLA Efficacy Supplements ..............................................................................................6 
IV.  Exceptions to User Fees ..........................................................................................................7 
V.  User Fee Payments ..................................................................................................................8 
VI.  User Fee Refunds ....................................................................................................................9 
A.  eCopy criteria not met for a PMA Application .................................................................9 
B.  Acceptance criteria not met for a PMA Application ......................................................10 
C.  Applicant requests withdrawal of an Original PMA or Panel-Track Supplement before 
filing ................................................................................................................................10 
D.  Filing criteria not met for an Original PMA or Panel-Track Supplement ......................10 
E.  Applicant requests withdrawal of a filed Original PMA or Panel-Track Supplement, but 
FDA has not taken a first action .....................................................................................10 
F.  FDA has taken a first action on an Original PMA or Panel-Track Supplement .............11 
G.  Modular PMAs................................................................................................................12 
H.  Premarket Reports ...........................................................................................................12 
I.  Licensing Agreement PMAs ...........................................................................................12 
J.  180-Day Supplements .....................................................................................................13 
K.  Real-Time Supplements ..................................................................................................13 
L.  30-Day Notices ...............................................................................................................13 
M. Periodic Reports ..............................................................................................................13 
N.  eCopy criteria not met for a BLA Application ...............................................................13 
O.  Applicant requests withdrawal of an Original BLA or Efficacy Supplement before 
filing ................................................................................................................................14 
P.  Filing criteria not met for an Original BLA or Efficacy Supplement .............................14 
Q.  Applicant requests withdrawal of a filed Original BLA or Efficacy Supplement, but 
FDA has not taken a first action .....................................................................................14 
R.  FDA has taken a first action on an Original BLA or Efficacy Supplement ...................15 
VII.  How to Request a User Fee Refund ......................................................................................15 
 
  Contains Nonbinding Recommendations 
User Fees and Refunds for Premarket 
Approval Applications and Device 
Biologics License Applications 
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 
approval applications (PMAs) and certain biologics license applications (BLAs).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 For more information on performance goals for PMAs, see the 
guidance FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on 
FDA Review Clock and Goals Performance.4 
The purpose of this guidance document is to identify: (1) the types of PMAs and BLAs subject to 
device user fees; (2) exceptions to user fees; and (3) the actions that may result in refunds of user 
fees that have been paid. 
 
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, including the user fees for the current fiscal year, 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. Performance goals established for BLAs are also outlined in this 
commitment letter. 
4 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-and-industry-actions-premarket-
approval-applications-pmas-effect-fda-review-clock-and-goals  
1  Contains Nonbinding Recommendations 
For information regarding bundling of multiple submissions, see Bundling Multiple Devices or 
Multiple Indications in a Single Submission.5  
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 use of 
the word should in Agency guidances means that something is suggested or recommended, but 
not required. 
II.  Types of PMAs Subject to User Fees6 
In accordance with the FD&C Act, as amended by MDUFA V, the following types of PMAs7 are 
subject to user fees: 
  Original PMAs; 
  Modular PMAs; 
  Premarket Reports; 
  Licensing Agreement PMAs; 
  Panel-Track Supplements; 
  180-Day Supplements; 
  Real-Time Supplements; 
  30-day Notices; and 
  Periodic Reports. 
A.  Original PMAs 
An original PMA is one in which all elements required under 21 CFR 814.20 are submitted at the 
same time in a single application. For original PMAs submitted on or after October 1, 2022, 
FDA will assess the user fee in effect at the time of the submission.8 
B.  Modular PMAs 
A modular PMA is a compilation of sections or modules that are submitted at different times 
that together become a complete application. For modular PMAs submitted on or after October 
1, 2002, FDA will assess the user fee in effect for an original PMA at the time of submission of 
 
5 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/bundling-multiple-devices-or-
multiple-indications-single-submission  
6 See section 738(a)(2)(A) of the FD&C Act. 
7 Section 737(1) of the FD&C Act includes product development protocols within the definition of premarket 
applications subject to user fees. 
8 See section 738(b)(2) of the FD&C Act. 
2  Contains Nonbinding Recommendations 
the first module.9 For more information on the modular PMA process, see the guidance 
document, Premarket Approval Application Modular Review.10  
C.  Premarket Reports 
A premarket report (PMR) is a marketing application for class III reprocessed single use devices 
(SUDs) that otherwise would have required a PMA.11 Among other information, a PMR must 
include validation data regarding cleaning, sterilization, and functional performance of the 
reprocessed device to ensure it is substantially equivalent to a legally marketed device. For 
PMRs submitted on or after October 1, 2022, FDA will assess the user fee in effect for an 
original PMA at the time of the submission. 
D.  Licensing Agreement PMAs 
A licensing agreement PMA involves a PMA applicant (hereafter referred to as a licensor) 
entering a licensing agreement with another party (hereafter referred to as a licensee) to provide 
that party with permission to reference the data in its PMA. The licensee, after submitting the 
licensing agreement PMA to FDA, may request FDA to approve its own device, by referencing 
all the information that was used as a basis for approval of the licensors device. Upon receiving 
FDAs approval, the licensee assumes all the responsibilities of a PMA applicant, including the 
manufacture and distribution of a device that is identical to the licensors. In addition, following 
approval of the licensing agreement PMA, licensees may choose to make changes to their 
product. As for all PMA applicants, such changes may require the submission of a PMA 
supplement. 
Under the FD&C Acts user fee provisions, there is no distinction with respect to fee amounts for 
PMAs based on licensing agreements and those based on original data.12 Therefore, original 
PMAs and PMA supplements based on licensing agreements are subject to the same fees as 
submissions based on original data. Similarly, certain PMA supplements submitted to a 
licensees PMA would be subject to a user fee just as such supplements to a licensors PMA 
would be subject to user fees. 
E.  Panel-Track Supplements 
Section 737(4)(B) of the FD&C Act defines panel-track supplement as supplement to an 
approved premarket application or premarket report under section 515 that requests a significant 
change in design or performance of the device, or a new indication for use of the device, and for 
which substantial clinical data are necessary to provide a reasonable assurance of safety and 
effectiveness. For more information on panel-track supplements, see the guidance document, 
 
9 See section 738(a)(2)(C) of the FD&C Act. 
10 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/premarket-approval-application-
modular-review  
11 See section 515(c)(2)(A) of the FD&C Act. 
12 See section 738(a)(2)(A) of the FD&C Act. 
3  Contains Nonbinding Recommendations 
Modifications to Devices Subject to Premarket Approval (PMA)  The PMA Supplement 
Decision-Making Process.13  
For panel-track supplements submitted on or after October 1, 2022, FDA will assess the user fee 
in effect at the time of submission.14  
F.  180-Day Supplements 
Section 737(4)(C) of the FD&C Act defines 180-day supplement as a supplement to an 
approved premarket application or premarket report under section 515 that is not a panel-track 
supplement and requests a significant change in components, materials, design, specification, 
software, color additives, or labeling. For more information on 180-day supplements, see the 
guidance document, Modifications to Devices Subject to Premarket Approval (PMA)  The 
PMA Supplement Decision-Making Process.15  
For 180-day supplements submitted on or after October 1, 2022, FDA will assess the user fee in 
effect at the time of the submission.16 
G.  Real-Time Supplements 
Section 737(4)(D) of the FD&C Act defines real-time supplement as a supplement to an 
approved premarket application or premarket report under section 515 that requests a minor 
change to the device, such as a minor change to the design of the device, software, sterilization, 
or labeling, and for which the applicant has requested and the Agency has granted a meeting or 
similar forum to jointly review and determine the status of the supplement. For more 
information on real-time supplements, see the guidance documents, Real-Time Premarket 
Approval Application (PMA) Supplements17  and Modifications to Devices Subject to 
Premarket Approval (PMA)  The PMA Supplement Decision-Making Process.18 
For real-time supplements submitted on or after October 1, 2022, FDA will assess the user fee in 
effect at the time of the submission.19 
H.  30-Day Notices 
Section 737(5) of the FD&C Act defines 30-day notice as a notice under section 515(d)(5) 
that is limited to a request to make modifications to manufacturing procedures or methods of 
 
13 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/modifications-devices-subject-
premarket-approval-pma-pma-supplement-decision-making-process  
14 See section 738(a)(2)(A)(iii) of the FD&C Act. 
15 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/modifications-devices-subject-
premarket-approval-pma-pma-supplement-decision-making-process  
16 See section 738(a)(2)(A)(iv) of the FD&C Act. 
17 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/real-time-premarket-approval-
application-pma-supplements  
18 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/modifications-devices-subject-
premarket-approval-pma-pma-supplement-decision-making-process  
19 See section 738(a)(2)(A)(v) of the FD&C Act. 
4  Contains Nonbinding Recommendations 
manufacture affecting the safety and effectiveness of the device. Additionally, per 21 CFR 
814.39(f) If the [30-day] notice is not adequate, FDA shall inform the applicant in writing that a 
135-day PMA supplement is needed and shall describe what further information or action is 
required for acceptance of such change. For more information on 30-day notices and 135-day 
supplements, see the guidance documents, 30-Day Notices, 135-Day Premarket Approval 
(PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for 
Manufacturing Method or Process Changes20 and Modifications to Devices Subject to 
Premarket Approval (PMA)  The PMA Supplement Decision-Making Process.21  
For 30-day notices received on or after October 1, 2022, FDA will assess the user fee in effect at 
the time of the submission.22 If a 30-day notice is converted to a 135-day supplement, the user 
fee paid for the 30-day notice will not be refunded. 
I.  Periodic Reports 
In accordance with 21 CFR 814.82(a)(7), FDA may require, as a condition of approval, 
submission to FDA at intervals specified in the approval order of periodic reports containing the 
information required by 21 CFR 814.84(b). In most cases, after the PMA is approved, the PMA 
applicant is required to submit reports to FDA annually unless a different timeframe is specified 
in the approval order. Accordingly, periodic reports are typically referred to by FDA and 
industry as annual reports. Periodic reports are separate from the post-approval study reports, 
which are discussed in the guidance document, Procedures for Handling Post-Approval Studies 
Imposed by Premarket Approval Application Order.23 Under section 738(a)(2)(A)(x) of the 
FD&C Act, PMA applicants are subject to an annual fee for periodic reporting concerning a 
class III device. FDA will assess the user fee in effect at the time of the submission of the 
periodic report.24 Note that PMAs are not subject to the periodic reporting user fee until the first 
fiscal year following approval of the original PMA. Typically, this corresponds to when the first 
periodic report would be due. Also, devices with approved PMAs that have been subsequently 
reclassified into class II or withdrawn are not subject to PMA regulations and therefore will not 
be assessed a periodic reporting user fee. Although FDA has allowed some applicants to submit 
bundled periodic reports, the annual fee is required for each approved PMA identified in the 
periodic report. 
 
20 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/30-day-notices-135-day-premarket-
approval-pma-supplements-and-75-day-humanitarian-device-exemption  
21 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/modifications-devices-subject-
premarket-approval-pma-pma-supplement-decision-making-process  
22 See section 738(a)(2)(A)(vi) of the FD&C Act. 
23 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/procedures-handling-post-approval-
studies-imposed-pma-order  
24 See section 738(a)(2)(A)(x) of the FD&C Act. 
5  Contains Nonbinding Recommendations 
III.  Types of Biologics License Applications Subject to 
Device User Fees 
In accordance with the FD&C Act, as amended by MDUFA V, the following applications for 
devices subject to licensure under section 351 of the Public Health Service Act, are subject to 
user fees: 
  Original biologics license applications (BLAs), which are included in the user fee 
definition of premarket application in section 737(1) of the FD&C Act; and 
  BLA Efficacy Supplements (BLSs), which are defined for user fee purposes in section 
737(4)(E) of the FD&C Act. 
Under sections 738(a)(2)(A)(i) and (vii) of the FD&C Act, both applications are assessed the 
user fee applicable to a premarket application that is in effect at the time of the submission. 
A.  Original BLAs 
An original BLA is one in which all elements required under 21 CFR 601.2 are submitted at the 
same time in a single application. User fees will be assessed for original applications.  
B.  BLA Efficacy Supplements 
According to section 737(4)(E) of the FD&C Act, efficacy supplement is defined as a 
supplement to an approved premarket application under section 351 of the Public Health Service 
Act that requires substantive clinical data.  
User fees will be assessed for efficacy supplements containing the types of clinical data that are 
required to form the primary basis for approval, e.g., study reports or literature reports that are 
explicitly or implicitly represented by the applicant to be adequate and well-controlled trials. 
 
For purposes of assessing user fees, clinical data do not include data used solely to modify the 
labeling to add a restriction that would improve the safe use of the product (e.g., to add a 
limitation or warning to the labeling). In addition, supplements to BLAs based solely on 
equivalence studies (in-house testing with limited external testing) are not considered to contain 
clinical data for purposes of assessing user fees. 
 
For the types of changes listed below, substantive clinical data are generally necessary to 
demonstrate the equivalence of the identity, strength, quality, purity, or potency of the product as 
they may relate to the safety or effectiveness of the product. Therefore, applicants should submit 
an efficacy supplement and pay the associated fee for: 
 
 a new indication for use (e.g., new platform, new patient population/disease state); 
 a significant change in design; or 
 a significant change in performance. 
6  Contains Nonbinding Recommendations 
 
For example, a change in an HIV test kit for blood donor screening to include an additional strain 
or a change in a Blood Grouping Reagent to include a different source of raw material (e.g., 
changing from one monoclonal antibody cell line to another) both require substantive clinical 
data to support the change. Therefore, these would be classified as efficacy supplements and 
would require payment of the associated user fee. 
 
IV.  Exceptions to User Fees 
Under the FD&C Acts user fee provisions, any PMA or BLA that is intended solely for a 
pediatric population is exempt from user fees.25 There may be situations where, upon review of 
the device and its intended population, FDA determines that the application qualified for the 
pediatric exception although the applicant did not request a waiver. In such a case, FDA would 
refund the user fee upon request. However, if after approval of an original or modular PMA or a 
BLA for pediatric use, the applicant proposes conditions of use for an adult population, the 
supplement is subject to the full user fee of a traditional PMA or BLA in effect at the time of 
submission.26 
A first ever original PMA or BLA submitted by a qualifying small business is also granted a one-
time waiver of the user fee. To quality for this exception, a business, together with its affiliates, 
must have gross receipts or sales of no more than $30 million for the most recent tax year.27 
Additionally, a BLA submitted under section 351 of the Public Health Service Act for a product 
licensed for further manufacturing use only is exempt from user fees.28 
The FD&C Act also allows an exception from user fees for a PMA or BLA submitted by a state 
or federal government entity unless the device involved is to be distributed commercially.29 
While permitted by statute, FDA does not commonly receive PMAs or BLAs submitted under 
these circumstances. 
The following PMA supplements are not subject to user fees and do not require submission of 
user fee cover sheets: 
  Special PMA supplement  Changes Being Effected (CBE); 
  PMA supplement for manufacturing/sterilization site change without associated design 
changes; 
  PMA supplement for trade name change; 
  PMA supplement for post approval study protocol; and 
  PMA post approval study labeling update. 
 
 
25 See section 738(a)(2)(B)(v)(I) of the FD&C Act. 
26 See section 738(a)(2)(B)(v)(II) of the FD&C Act. 
27 See section 738(d)(1) of the FD&C Act. 
28 See section 738(a)(2)(B)(ii) of the FD&C Act. 
29 See section 738(a)(2)(B)(iii) of the FD&C Act. 
7  Contains Nonbinding Recommendations 
The following BLA supplements submitted in accordance with 21 CFR 601.12 are not subject to 
user fees: 
 
  Prior Approval Supplements (PASs) that do not meet the definition of an efficacy 
supplement 
  Changes Being Effected in 30 days (CBE-30s) 
  Changes Being Effected (CBEs) 
  Annual reports (ARs) 
V.  User Fee Payments 
As outlined below, there are three ways you may submit your user fee.30 Be sure to include the 
Payment Identification Number (PIN, beginning with MD)31 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 $24,499.99. 
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 application. 
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. 
 
30 Additional information regarding payment of user fees is available at 
https://userfees.fda.gov/OA_HTML/mdufmaFAQ.html. 
31 A PIN is obtained after creating a User Fee Cover Sheet and selecting Submit Cover Sheet to FDA. 
8  Contains Nonbinding Recommendations 
3)  Wire Transfer: Please include your application'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 
application 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 
 
VI.  User Fee Refunds 
User fee refunds are handled as described below. 
A.  eCopy criteria not met for a PMA  
FDA has issued the guidance, eCopy Program for Medical Device Submissions,32 to 
implement section 1136 of Food and Drug Administration Safety and Innovation Act (FDASIA), 
which added section 745A(b) of the FD&C Act, and provides statutory authority to require 
eCopy. 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 the applicant in writing to aid in their creation of a valid replacement eCopy. If 
a valid eCopy 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 also send a written request to withdraw your submission before receiving a 
deletion letter and request a refund of the fee paid. Note that your fee will not be refunded if you 
fail to provide a valid eCopy of a response to an additional information request after first action 
on the PMA. 
 
32 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ecopy-program-medical-device-
submissions  
9  Contains Nonbinding Recommendations 
B.  Acceptance criteria not met for a PMA 
If after an administrative review, FDA refuses to accept the PMA, the applicant will be notified 
within 15 calendar days of receipt that the submission has not been accepted. The applicant may 
submit additional information to the PMA to address the reasons for the refusal without 
submitting a new user fee. Alternatively, the applicant may send a written request to withdraw 
the submission and request a refund of the fee paid if the applicant decides not to provide 
additional information.   
C.  Applicant requests withdrawal of an Original PMA or 
Panel-Track Supplement before filing 
If an applicant requests withdrawal of an original PMA or panel-track supplement after the 
acceptance decision but before FDA makes the filing decision, we will refund 75% of the user 
fee.33 
D.  Filing criteria not met for an Original PMA or Panel-
Track Supplement 
If FDA issues a not-filed letter for an original PMA or panel-track supplement, the applicant can 
request a refund of 75% of the fee paid.34 When an applicant amends a PMA to respond to a not-
filed letter, FDA will require the full user fee in effect at the time of submission. If FDA does not 
receive a response to a not-filed letter within 360 days, the PMA will be deleted from our 
system.35 For additional information, please refer to the guidance, Acceptance and Filing 
Reviews for Premarket Approval Applications (PMAs).36 
E.  Applicant requests withdrawal of a filed Original PMA or 
Panel-Track Supplement, but FDA has not taken a first 
action 
FDA has the discretion to refund fees if an applicant withdraws its PMA or panel-track 
supplement after FDA has filed it but before we have taken a first action.37 First actions may be 
the issuance of a major deficiency letter, a not approvable letter, an approvable letter, an 
approval order, or a withdrawal letter. See the guidance document, FDA and Industry Actions 
 
33 See section 738(a)(2)(D)(ii) of the FD&C Act. 
34 See section 738(a)(2)(D)(i) of the FD&C Act. 
35 Under FDA regulations for review of PMAs, FDA also considers an original PMA or PMA supplement to have 
been voluntarily withdrawn if an applicant fails to respond in writing to a written request for an amendment within 
180 days after the date FDA issues such request. See 21 CFR 814.44(g).  
36 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-and-filing-reviews-
premarket-approval-applications-pmas  
37 See section 738(a)(2)(D)(iii) of the FD&C Act. 
10  Contains Nonbinding Recommendations 
on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals,38 for 
more information regarding PMA actions. 
FDA will base any refund it issues when the application is withdrawn  after a filing but before a 
first action is taken on the level of effort already expended on the review, as required by the 
FD&C Act.39 FDA believes that, in most instances, our level of effort can be appropriately 
assessed by the number of calendar days that an application was under review. This approach 
permits FDA to calculate and process refunds much more efficiently than if we were to attempt 
to estimate factors on a case-by-case basis, such as the amount of time each member of the 
review team spent on the review and the significance and complexity of the scientific, medical, 
technical, and regulatory issues examined during the course of the review. 
For these reasons, FDA intends to make refunds by referring to the following guidelines for 
original PMAs and panel-track supplements: 
  when withdrawn between the date of the filing decision and day 90, a 50% refund of the 
user fee; 
  when withdrawn between day 91 and day 135, a 25% refund of the user fee; or 
  when withdrawn after day 135, no user fee refund. 
FDA recognizes, however, that when there are unusual circumstances, the number of calendar 
days that an application was under review may not provide a complete picture. Under such 
unusual circumstances, FDA may take additional factors other than the number of calendar days 
under review into consideration. 
Although you may request that FDA reconsider its decision about a user fee refund, the Secretary 
has sole discretion to refund a fee or portion of the fee for an application withdrawn after filing 
but before a first action.40 A determination by the Secretary concerning a refund is not 
reviewable.41  
F.  FDA has taken a first action on an Original PMA or 
Panel-Track Supplement 
In accordance with the FD&C Act, if an applicant requests withdrawal of an original PMA or 
panel-track supplement at any time after FDA has taken its first action, regardless of when the 
action is taken, FDA will not refund any portion of the user fee.42 
 
38 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-and-industry-actions-premarket-
notification-510k-submissions-effect-fda-review-clock-and-goals  
39 See section 738(a)(2)(D)(iii) of the FD&C Act. 
40 See section 738(a)(2)(D)(vi) of the FD&C Act. 
41 Id. 
42 See section 738(a)(2)(D)(iii). 
11  Contains Nonbinding Recommendations 
G.  Modular PMAs 
For a modular PMA, the applicant is required by statute to pay a full fee for an original PMA 
when the first module is submitted.43 Although there is no filing review completed on the 
individual modules, actions can be taken. Module actions include an acceptance letter or a 
deficiency letter. 
Upon receipt of the last module, the modular PMA is converted to an original PMA review track. 
At that point, the filing review for that PMA is initiated. See the guidance document, Premarket 
Approval Application Modular Review,44 for a complete discussion of the modular PMA 
review program. 
User fee refunds for modular PMAs will be handled in the following manner: 
  when withdrawn prior to submission of a second module and before a first action on the 
first module, a 75% refund of the user fee;45 or 
  when withdrawn after a second or subsequent module is submitted but before any first 
action on that module, the refund, if any, will be based on the level of effort already 
expended on the review on the modules submitted.46 For this situation, FDA intends to 
make refunds by referring to the following guidelines: 
  after a second module but before any first action on that module, 50% refund of 
o
the user fee; 
  after a third module but before any first action on that module, 25% refund of the 
o
user fee; or 
  after a fourth or subsequent module, no user fee refund. 
o
 
H.  Premarket Reports 
For premarket reports, FDA will follow the same user fee refund provisions as described above 
for original PMAs in section VI, parts C through F. 
I.  Licensing Agreement PMAs 
Licensing agreement PMAs are considered filed upon receipt. As stated previously, FDA will 
base any refund it issues after a filing but before a first action is taken on the level of effort 
already expended on the review, as required by the FD&C Act.47 In cases where an applicant 
submits a licensing agreement PMA that includes new manufacturing procedures and/or a new 
manufacturing facility and requests withdrawal before FDA takes its first action, we intend to 
apply the refund policy discussed above for original PMAs (see section VI, part E above). If, 
 
43 See section 738(a)(2)(C) of the FD&C Act. 
44 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/premarket-approval-application-
modular-review  
45 See section 738(a)(2)(D)(iv) of the FD&C Act. 
46 See section 738(a)(2)(D)(v) of the FD&C Act. 
47 See section 738(a)(2)(D)(iii) 
12  Contains Nonbinding Recommendations 
however, the licensing agreement PMA incorporates by authorized reference all the information 
required by 21 CFR 814.20, including the same manufacturing procedures and facilities, and an 
applicant requests withdrawal before a first action (generally an approval order), FDA plans to 
refund the full user fee based on the level of effort. 
J.  180-Day Supplements 
For 180-day supplements, FDA considers the application filed upon receipt. The fees for these 
types of supplements are significantly less than those required for original PMAs, and, generally, 
the reviews are conducted over a shorter period of time. Therefore, in accordance with FDAs 
authority under section 738(a)(2)(D)(iii) of the FD&C Act, which bases the refund on the 
amount of effort expended, FDA does not intend to refund any amount of the user fee for this 
type of supplement after it has been filed. 
K.  Real-Time Supplements 
For real-time supplements, FDA will follow the same user fee refund provisions as described 
above for 180-day supplements. 
L.  30-Day Notices 
For 30-day notices, or for 30-day notices that are converted to 135-day PMA supplements, FDA 
will follow the same user fee refund provisions as described above for 180-day supplements. 
M.  Periodic Reports 
FDA does not intend to refund any amount of the annual fee for periodic reports. 
N.  eCopy criteria not met for a BLA  
If FDA does not receive an eCopy,48 or receives an eCopy that cannot be accepted because it 
does not meet our technical requirements, the omission or reasons for that failure will be 
communicated to the applicant in writing to aid in their creation of a valid replacement eCopy. If 
a valid eCopy is not received within 180 calendar days of this notification, the submission will 
be closed in 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 also send a written request to withdraw your submission before receiving a 
deletion letter and request a refund of the fee paid. Note that your fee will not be refunded if you 
fail to provide a valid eCopy of a response to an additional information request after first action 
on the BLA.  
 
48 See the guidance document, eCopy Program for Medical Device Submissions, available at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ecopy-program-medical-device-
submissions. 
13  Contains Nonbinding Recommendations 
O.  Applicant requests withdrawal of an Original BLA or 
Efficacy Supplement before filing 
If an applicant requests withdrawal of an original BLA or efficacy supplement before FDA 
makes the filing decision, we will refund 75% of the user fee.49 
P.  Filing criteria not met for an Original BLA or Efficacy 
Supplement 
If FDA issues a refusal to file letter for an original BLA or efficacy supplement, the applicant 
can request a refund of 75% of the fee paid.50 When an applicant resubmits a BLA in response to 
a refusal to file letter, FDA will require the full user fee in effect at the time of resubmission. 
Q.  Applicant requests withdrawal of a filed Original BLA or 
Efficacy Supplement, but FDA has not taken a first action 
FDA has the discretion to refund fees if an applicant withdraws its BLA or efficacy supplement 
after FDA has filed it but before we have taken a first action.51 First action means the issuance of 
a complete response letter, an approval letter, or a withdrawal letter after the complete review of 
a filed complete application. 
FDA will base any refund it issues when the application is withdrawn after a filing but before a 
first action is taken on the level of effort already expended on the review, as required by the 
FD&C Act.52 FDA believes that, in most instances, our level of effort can be appropriately 
assessed by the number of calendar days that an application was under review. This approach 
permits FDA to calculate and process refunds much more efficiently than if we were to attempt 
to estimate factors on a case-by-case basis, such as the amount of time each member of the 
review team spent on the review and the significance and complexity of the scientific, medical, 
technical, and regulatory issues examined during the course of the review. 
For these reasons, FDA intends to make refunds by referring to the following guidelines for 
original BLAs and efficacy supplements: 
  when withdrawn between the date of the filing decision and day 152, a 50% refund of the 
user fee; 
  when withdrawn between day 152 and day 228, a 25% refund of the user fee; or 
  when withdrawn after day 228, no user fee refund. 
FDA recognizes, however, that when there are unusual circumstances, the number of calendar 
days that an application was under review may not provide a complete picture. Under such 
 
49 See section 738(a)(2)(D)(ii) of the FD&C Act. 
50 See section 738(a)(2)(D)(i) of the FD&C Act. 
51 See section 738(a)(2)(D)(iii) of the FD&C Act. 
52 Ibid. 
14  Contains Nonbinding Recommendations 
unusual circumstances, FDA may take additional factors other than the number of calendar days 
under review into consideration. 
Although you may request that FDA reconsider its decision about a user fee refund, [t]he 
Secretary has sole discretion to refund a fee or portion of the fee for an application withdrawn 
after filing but before a first action.53 A determination by the Secretary concerning a refund is 
not reviewable.54 
R.  FDA has taken a first action on an Original BLA or 
Efficacy Supplement 
In accordance with the FD&C Act, if an applicant requests withdrawal of an original BLA or 
efficacy supplement at any time after FDA has taken its first action, regardless of when the 
action is taken, FDA will not refund any portion of the user fee.55 
VII. How to Request a User Fee Refund 
To facilitate the Agencys orderly issuance of refunds, you should submit a written request56  for 
a refund to the appropriate Center in FDA within 180 calendar days after the fee was due.57  
 
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.  
 
 
 
 
53 See section 738(a)(2)(D)(vi) of the FD&C Act. 
54 Ibid.  
55 Section 738(a)(2)(D)(iii) of the FD&C Act does not provide FDA with authority to refund any portion of fees 
after the Agency has taken a first action on an application. 
56 The user fee payment refund request form is available at https://www.fda.gov/media/96650/download. 
57 See Section 738(j) of the FD&C Act. 
15