Contains Nonbinding Recommendations  
User Fees for  513(g) Requests for  
Information  
 
Guidance for Industry  and  
Food and Drug Administration  Staff  
Document  issued on  October 5, 2022.  
Document originally issued  on  April  6, 2012.  
This document supersedes User  Fees and Refunds for 513(g) Requests for  
Information 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  
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 Division of Dockets Management, 
Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD  
20852-1740. Identify all  comments with the docket number  FDA-2010-D-0144. 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 1709 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., 
Building 71, Room 3128, Silver Spring, MD 20993-0002, or by calling 1-800-835-4709 or 240-
402-8010, or by e-mail,  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  Concerning  User  Fees  for 513(g)  Requests  ...........................  2  
1.   Are all  513(g)  requests  subject  to  a user fee?  ......................................................................  2  
2.   What  are the 513(g)  user  fees?  ............................................................................................  2  
3.   How do I pay my user fee(s)?  ..............................................................................................  2  
4.   Will FDA refund my user fee payment if you determine that my submission is not a  
513(g) Request for  Information? .................................................................................................  3  
5.   Are there other  circumstances under  which FDA will refund my user fee payment for a  
513(g) Request for  Information? .................................................................................................  4  
6.   Do  I  have to  pay a new  user fee if  I  submit  a  510(k), De Novo Request, or Premarket  
Approval  Application  (PMA)  for my device following  my 513(g)  Request for Information? ....  4  
8.   Will  FDA  refund  my user  fee payment  if  I  withdraw  my 513(g)  request? ..........................  4  
9.   If  FDA  requests  additional  information  about  my product,  must  I  submit a new  user fee 
with  such  information? .................................................................................................................  4  
10.   Is  the completion  of  a medical  device user fee cover  sheet  required?  ..............................  4  
 
 
      Contains Nonbinding Recommendations  
User Fees  for  513(g)  Requests for  
Information  
 
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, 2022,2 including requests for 
information under section 513(g) of  the  FD&C Act (513(g) request).3  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.4  
The  purpose  of this  guidance  document is to assist  FDA  staff and regulated industry by 
describing the  user  fees  associated with 513(g)  requests.  
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  
 
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  A  request  for  classification  information  is  a  request  made  under  section  513(g) for  information  respecting  the  
class  in  which  a  device  has  been  classified  or  the  requirements applicable  to  a  device.  This  guidance  and  other  FDA  
publications  use  the  term  513(g) request  and  Request  for  Information  as a  synonym  for  this  term.  FDAs  
response  to  a  513(g) request  will  provide  information  regarding  device  classification  and/or  applicable  regulatory 
requirements.   
4  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  
the word should in Agency guidances means that  something is suggested or recommended, but  
not required.  
II.   Frequently Asked  Questions Concerning  User  Fees 
for  513(g) Requests  
1.   Are all  513(g)  requests  subject  to  a user fee?  
Yes. Section 738(a)(2)(A)(ix)  of the  FD&C  Act  requires  you to pay a  user  fee  for  any 513(g)  
request  that  you submit  to  FDA.  Unlike  other  types  of  medical  device  application fees, the  law  
does  not  provide  any exception to the  requirement  to pay the  fee  for  a  513(g)  request.5 For  
example, you will  have  to pay a  user  fee  for  your  513(g)  request  even if  your  submission is for  a  
device  intended solely for  a pediatric  population  or  you are  a  State  or  Federal  Government  
entity,  because neither the exception in section 738(a)(2)(B)(v)(I)  of the  FD&C Act nor the one  
in section 738(a)(2)(B)(iii) extends  to requests for  classification information.  
FDA  will  not  accept  your  513(g)  request  for  review  until  you have  paid all  fees  owed.6 FDAs  
review  of  your  513(g)  request  will  begin on the  date  that  all  owed fees  have  been received.  
2.   What  are the 513(g)  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.7 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. 
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. 
 
 
5  Section 738(a)(2)(B) of the FD&C Act provides certain exceptions to medical device user fees. However,  none  of 
these  apply to 513(g) requests.  
6  See section 738(f)  of the FD&C Act.  
7  Additional information regarding payment  of user  fees is available at  
https://userfees.fda.gov/OA_HTML/mdufmaFAQ.html.  
2    Contains Nonbinding Recommendations  
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  a phone number is also required for  
courier delivery, use (314) 418-4013.  
 
3)   Wire Transfer: Please include your  513(g)  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  
513(g)  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  
4.   Will  FDA refund my user fee payment if you determine that my  
submission is not a 513(g)  Request for Information?  
Yes. Section  513(g)  of  the  FD&C  Act  governs  requests  for  information  respecting  the  class  in  which  
a  device  has  been  classified  or  the  requirements applicable  to  a  device  under  [the]  Act. Submissions  
that  do  not  request  such information  are  outside  the  scope  of  section  513(g)  and  do  not  require  a  
response  from  FDA. If  FDA  determines  that  a  submission  is  not  a  513(g)  Request  for  Information  
and therefore  cannot be reviewed, FDA  intends  to  refund  the  user  fee.  
3     Contains Nonbinding Recommendations  
5.   Are there other circumstances under which FDA will refund  my user fee 
payment  for a 513(g)  Request for Information?   
No.  When a  513(g) request is submitted  to FDA for review  and the user fee is paid, the request  will 
undergo  review and FDA  will not refund your  user fee payment, regardless of the decision.  
 
6.   Do  I  have to  pay a new  user fee if  I  submit  a  510(k), De Novo Request,  or 
Premarket Approval  Application  (PMA)  for my device following  my 
513(g)  Request  for Information?  
Yes. You must  pay any applicable  fee  for  any new  submission type  following your  513(g)  
request.8  
7.   After I  submit  a 513(g)  Request  for  Information,  can  I  subsequently add a  
new  question,  use,  or technology without  submitting  a new  user fee?  
No. Once  FDA  has  received your  513(g)  Request  for  Information and user  fee, you may not  
modify that  513(g)  request  by subsequently adding a  new  question, use, or  technology. We  
consider  the  addition of a  new  question, use, or  technology to be  a  new  513(g)  request  subject  to 
an additional  user  fee, to which we  intend to respond separately.  
8.   Will  FDA  refund  my user  fee payment  if I  withdraw  my 513(g)  request?  
No. When a 513(g) request is submitted to FDA for review  and the user fee is paid, the request  
will undergo review  and FDA  will not  refund your user fee  payment.  
9.   If  FDA  requests  additional  information  about  my product,  must  I  submit 
a new  user fee with  such  information?  
No. Information submitted in response  to direct  FDA  requests  for  additional  information does  
not  require  an additional  user  fee  payment.  
10.    Is  the completion  of  a medical  device user fee cover sheet  required?  
Yes. You must  complete  and submit  FDA  Form  3601, Medical  Device  User  Fee  Cover  Sheet, 
along with your  request  for  information on classification. FDA Form 3601 is designed to provide  
the minimum necessary information to determine  whether a  fee is required for review of an 
application submission, to determine the amount of the fee required, and to help FDA track 
payments. The  form  may  be  found at https://www.fda.gov/industry/medical-device-user-fee-
amendments-mdufa/mdufa-cover-sheets.  
 
8  See section 738(a) of the FD&C Act.  
4