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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.
FDA offers your organization the ability to complete a Medical Device User Fee Cover Sheet online and submit it electronically. To fill out the form online, you need Microsoft Internet Explorer 5.5 or higher or Netscape Navigator 4.7 or higher. Instructions for checking and updating your browser can be found at www.fda.gov/cber/browser.htm.
Read the instructions below and then go to the MDUFMA User Fee Coversheet to fill out the form.
1. You will register on-line by providing the following information:
EIN numbers are required for U.S. firms, and DUNS numbers are recommended (but optional) for foreign firms. 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.
Please send a printed copy of the completed Cover sheet along with a check, bank draft, or U.S. Postal money order made payable to the Food and Drug Administration for the fee amount due. Remember to include the Payment Identification Number, beginning with 'MD', and the FDA P.O. Box on the enclosed check.
US Bank Lock Box
P.O. Box 956733
St. Louis, MO 63195-6733
Note:
In no case should payment be submitted with the application.
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.
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.
Account Name: Food and Drug Administration
Account Number:
152302010631
Routing Number: 081000210
Swift Number: USBKUS44IMT
Also
include your user fee payment identification number from your Medical Device
User Fee Cover sheet when you send payment by wire transfer.
Contact US Bank at 314-418-4821 if you have any questions on how to send payment(s) by wire transfer.
Mail application and include a copy of the completed Cover sheet as the first page of your application and each copy to:
Food and Drug Administration
Center for Devices and Radiological Health
(CDRH)
Document Mail Center
HFZ-401
9200 Corporate Blvd.
Rockville,
MD 20850
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 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 301-827-9539 or via email at [email protected].
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: Division of Small Manufacturers, Internet, and Consumer Assistance
(DSMICA)
FDA Center for Devices and Radiological Health
1-800-638-2041 or
240-276-3150
Contact: Office of Communication, Training and Manufacturers
Assistance
FDA Center for Biologics Evaluation and Research
301-827-2000
OMB No. 0910-0511
Form FDA 3601 (08/05)