Medical Device User Fee Cover Sheet - FDA Form 3601

MDUFMA User Fees Cover Sheet

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For Industry
MDUFMA User Fees Cover Sheet
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.
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:
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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

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MDUFMA User Fees Cover Sheet

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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 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 314-4184821 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
TREAS NYC
33 Liberty Street

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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

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Center for Biologic Evaluation and Research 301-827-2000
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Create MDUFMA User Fee Cover Sheet

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

http://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFeeandModernizationAct/...

12/10/2009