To submit this form, complete the Medical Device User Fee Cover Sheet and print a copy. Mail the printed cover sheet along with your payment to: US Bank Lock Box, P.O. Box 956733, St. Louis, MO 63195-6733. For courier delivery, send to: US Bank, ATTN: Government Lockbox 956733, 1005 Convention Plaza, St. Louis, MO 63101. Contact the US Bank at 314-418-4821 for any questions about courier delivery. If using wire transfer, ensure all associated fees are covered and include the user fee payment identification number. Mail the application including a copy of the completed cover sheet as the first page 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 to the FDA's Center for Biologics Evaluation and Research at 1401 Rockville Pike, Suite 200 N, HFM-99 (Document Control Room), Rockville, MD 20852-1448. My advice is to thoroughly review your form before submission to avoid any delays.

The purpose of the MDUFMA User Fee Cover Sheet is to facilitate the submission of medical device applications to the FDA. This form ensures that all necessary information is collected for the FDA to track fee payments and review submissions efficiently. By completing this form accurately, manufacturers and organizations can streamline the application process and comply with regulatory requirements.

• 1. Employer Identification Number (EIN): A unique number assigned to U.S. firms for identification.
• 2. Dun & Bradstreet Number (DUNS): An optional identifier recommended for foreign firms.
• 3. Organization Number: Another identifier option for registration purposes.
• 4. Contact Name: The name of the person to be contacted.
• 5. Company Name: The name of the organization submitting the application.
• 6. Address: The location details of the organization.
• 7. City: The city where the organization is located.
• 8. State: The state where the organization is located.
• 9. Zip Code: The postal code for the organization's address.
• 10. Country: The country where the organization is based.
• 11. Telephone: The contact phone number for the organization.
• 12. Fax: The fax number for the organization.
• 13. E-mail: The contact email address for the organization.

Failure to submit this form can result in delays in application review and potential non-compliance with FDA regulations.

• Delayed Review: Your application will not be processed until the form is submitted.
• Regulatory Non-Compliance: Not submitting the form can result in non-compliance with FDA requirements.
• Tracking Issues: Failure to submit the form can make tracking fee payments and applications difficult.

• 1. New Device Application: Submit this form when applying for a new medical device approval.
• 2. User Fee Payment: Complete the form to accompany your user fee payment.
• 3. Tracking Submissions: Use the form to track your submissions and fee payments.