Medical Device User Fee Cover Sheet - FDA Form 3601

Medical Device User Fee and Modernization Act (MDUFMA) > MDUFMA User Fees Cover Sheet

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User Fees

Medical Device User Fee and Modernization Act (MDUFMA)

MDUFMA User Fees Cover Sheet

Medical Device User Fee and
Modernization Act (MDUFMA)
MDUFMA User Fees Cover
Sheet
MDUFMA Annual Reports to
Congress

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 MDUFMA 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. To fill out the form online, you need Microsoft Internet Explorer 5.5 or higher or Netscape
Navigator 4.7 or higher.

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Read the instructions below and then go to Create MDUFMA 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 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 righthand corner, beginning with the letters MD. This number will assist FDA in tracking your payment and
submission for the review process.

Submitting Payment
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.

Mail payment and cover sheet to:
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 checks are to be sent by a courier that requires a street address, the courier can
deliver the checks 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 314-418-4013 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.
US Department of Treasury

http://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFeeandModernizationAct/ucm155274.htm[2/6/2013 7:57:13 AM]

Medical Device User Fee and Modernization Act (MDUFMA) > MDUFMA User Fees Cover Sheet
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 [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, International, and Consumer Assistance (DSMICA)
FDA Center for Devices and Radiological Health
1-800-638-2041 or 301-796-7100
Contact:  Office of Communication, Training and Manufacturers Assistance FDA Center for Biologic Evaluation
and Research 301-827-2000
Create MDUFMA User Fee Cover Sheet
OMB No. 0910-0511
Form FDA 3601 (01/07)
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Page Last Updated: 07/11/2012
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