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U.S. Department of Health and Human Services

Medical Devices

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FDA Device Establishment Registration and Listing Update - July 2009

This information is about the annual device establishment registration user fee, which some firms are required to pay annually.

How do I know if I need to pay the Annual Device Establishment Registration User Fee (also know as a Device Facility User Fee)?
A chart of who is responsible for paying the annual fee can be found on our website at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/ RegistrationandListing/ucm053165.htm

Can I complete the annual registration and listing first and pay the fee later?
No. If your firm is required to pay, you must first pay the fee before you start the annual registration and listing process. The FY 2010 annual registration fee cannot be paid until after October 1, 2009.

Can I use the Account ID and password that I have for the electronic registration and listing system (FURLS) to pay my fee?
No. The FDA User Fee website uses a 'Username' and password that is different from FURLS. The Username and password for the FDA User Fee system were created by you when you first set up your account in the User Fee system.

What if I don't remember my password or Username for the User Fee system?
If you know your Username, but don't remember your password, click on the 'Forgot Your Username/Password information?' link. You will be asked to enter your Username and the email address you used when you first set up your FDA User Fee system account. Your password will be reset and sent to you by email.

If you don't remember your Username or need any additional help accessing your User Fee account, please send an email to userfees@fda.gov or contact them by phone at (301) 796-7200 and the User Fee Helpdesk will assist you.

What is an Organization Number?
The Organization Number uniquely identifies your business in the FDA User Fee system and is assigned when you first create an FDA User Fee system account. This number enables FDA to track payments received for the annual device establishment user fee that you submit. The Organization Number is not used or found in any other FDA website, including the electronic registration and listing system (FURLS). Please contact the helpdesk at userfees@fda.gov or (301) 796-7200 if you need to retrieve your Organization Number.

What forms of payment are accepted?
You can pay the fee online with a credit card or use an ACH electronic check. Information is also available on the User Fee website on how to mail in a paper check. Foreign firms who cannot pay for the device establishment registration fee by credit card, electronic check, or a check drawn on a US bank, must pay by wire transfer. Foreign firms that are paying by wire transfer should send their payment to the wire transfer address listed on the order form that will be generated once you create an order to pay the fee. Foreign firms can also contact userfees@fda.gov for assistance on how to pay.

When completing the annual registration process, how do I indicate that I have paid the user fee?
When you create an order to pay the fee, you are assigned a Payment Identification Number (PIN). You need the PIN in order to submit a payment. Once FDA receives and processes your payment, FDA will send you an email with instructions on how to retrieve your Payment Confirmation Number (PCN). Your PIN and PCN are your proof of payment. You will be asked to enter these numbers in the electronic registration and listing system (FURLS) during the annual registration and listing process. If your firm is responsible for paying the annual user fee and you complete your electronic registration and were not asked to enter the PIN/PCN number, there may be a problem with your registration. Please contact us for assistance at reglist@cdrh.fda.gov.

What if I still have questions or need help?
If you have any questions about the payment process, you may contact userfees@fda.gov or by phone at (301) 796-7200. If you have questions about device registration and listing, please contact us at reglist@cdrh.fda.gov. Copies of this newsletter can be found on our website by going to the Registration and Listing website and selecting the Documents link.

Theresa McDonald
Chief, Regulatory Policy and Systems Branch
Division of Risk Management Operations
Office of Compliance
Center for Devices and Radiological Health