Medical Device User Fee Cover Sheet
The Medical Device User Fee Cover Sheet is the initial step required for your Medical Device Submission. By completing this cover sheet, you will be assigned a unique Payment Identification Number that distinguishes your fee payment and submission.
What you need to do:
- Complete the Medical Device User Fee Cover Sheet online (See
browser requirements below) before payment is sent. The completed cover sheet, when printed, automatically assigns a unique Payment Identification Number that appears only on the printed copy.
- Include a printed copy of the completed Cover Sheet with a check made payable to the Food and Drug Administration. Remember that the Payment Identification Number must be written on the check.
- Mail them to the US Bank Lock Box, P.O. Box 956733, St. Louis, MO 63195-6733. (Note:
In no case should payment be submitted with the application.)
- If you prefer to send a check by courier, the courier may deliver the check and Cover Sheet to: US Bank, Attn: Government Lockbox 956733, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This address is for courier delivery only. Contact the US Bank at 314-418-4821 if you have any questions concerning courier delivery.)
- For Wire Transfer Payment Procedures, please refer to the MDUFMA Fee Payment Instructions at the following link http://www.fda.gov/cdrh/mdufma/faqs.html#3a. Please remember that your bank or financial institution may assess a fee for sending a wire transfer. You are responsible for paying all fees associated with wire transfers.
- Include a copy of the completed Cover Sheet in volume one of the application when submitting to the FDA at either the CBER or CDRH Document Mail Center.
Medical Device User Fee Cover Sheet
Instructions for Completing the Medical Device User Fee Cover Sheet
How to get help if you:
- Already submitted an application and/or payment and forgot your Payment Identification Number
- Are unable to use the online system;
- Are unsure whether or not you need to file an application with FDA; and
- Are unsure what type of application to file.
Please Contact:
- Medical Devices - 1-800-638-2041 or 1-301-443-6597; or
- Biologics - 1-301-827-3503.
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