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  1. Medical Device User Fee Amendments (MDUFA): Fees

MDUFA Cover Sheets

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The Medical Device User Fee Cover Sheet is required for your Medical Device Application Submission. After completing the cover sheet, you will be assigned a unique user fee payment identification number that distinguishes and tracks your fee payment and submission.

How to Fill Out the MDUFA User Fee Cover Sheet On-line:

FDA offers your organization the ability to complete a Medical Device User Fee Cover Sheet online and submit it electronically.

Read the instructions below and then go to Create MDUFA User Fee Cover Sheet to fill out the form.

1. You will register on-line by providing the following information:

  • One of the following: Employer Identification Number (EIN), Dun & Bradstreet Number (DUNS), or Organization Number
  • Contact Name
  • Company Name
  • Address
  • City
  • State
  • Zip Code
  • Country
  • Telephone
  • Fax
  • E-mail

EIN numbers are required for U.S. firms, and DUNS numbers are required for foreign firms. You will need to have an EIN or DUNS number to create a User Fee account and proceed with registration. If you have previously registered with the FDA User Fee System for an ADUFA or PDUFA cover sheet, you will have been issued an Organization ID number (Org ID). The Org ID uniquely identifies your organization to the FDA. You will need one of these three numbers to proceed with registration.

2. Fill out the Medical Device User Fee Cover Sheet. Please answer a series of questions regarding the type of application being submitted for FDA's review. You will have the opportunity to view the cover sheet in draft form before submitting it to FDA.

3. When you are done, click the SUBMIT button to complete the cover sheet submission process. A form will appear with an electronically generated user fee payment identification number that is located in the upper right-hand corner, beginning with the letters MD. This number will assist FDA in tracking your payment and submission for the review process.

Submitting Payment

PLEASE NOTE NEW PAYMENT METHODS BEGINNING FY26

In accordance with the President’s Executive Order 14247- Modernizing Payments to and from America’s Bank Account, the FDA will no longer be accepting checks beginning October 1, 2025. The preferred method of payment is online using electronic check (Automated Clearing House (ACH) also known as eCheck or by bank wire.

Individuals, corporations, or other public or private entities that qualify for an exemption from the use of electronic funds transfers should reach out to the User Fees Support Staff at OO-OFBA-OFM-UFSS-Government@fda.hhs.gov for assistance.

The preferred payment method is online using electronic check (Automated Clearing House (ACH) also known as eCheck) or credit card.

Make an online payment at https://userfees.fda.gov/pay.

If using a wire transfer, you may send your payment using the following information.
You are responsible to pay any administrative costs associated with the processing of a wire transfer. Contact your bank or financial institution regarding additional fees. Please note that the review of your applications can not begin until full payment is received.

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
Please include the user fee payment identification number, beginning with "MD" and ensure that the fee that your bank will charge for the wire transfer is added to your fee payment.

Mailing the Application

Mail application and include a copy of the completed Cover sheet as the first page of your application and each copy to:

U.S. Food and Drug Administration
Center for Devices and Radiological Health
Document Mail Center – WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

or

Food and Drug Administration
Center for Biologics Evaluation and Research
1401 Rockville Pike, Suite 200 N
HFM-99 (Document Control Room)
Rockville, MD 20852-1448

If You Have Problems:

If you already submitted an application and/or payment and forgot your user fee payment identification number or are unable to use the online system:

Contact the FDA User Fees Financial Support Team at 301-796-7200 or via email at userfees@fda.gov.

If you are unsure whether or not you need to file an application with FDA or are unsure what type of application to file

Contact: CDRH-Division of Industry and Consumer Education (DICE)
FDA Center for Devices and Radiological Health
1-800-638-2041 or 301-796-7100

Contact: Office of Communication, Outreach and Development, Division of Manufacturers Assistance and Training (DMAT) at 240-402-8020 and Industry.Biologics@fda.hhs.gov.

Create MDUFA User Fee Cover Sheet

OMB No. 0910-0511
Form FDA 3601 (01/07)

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