FDA Device Establishment Registration and Listing Update - September 2009
The following letter was sent to the owner operator and official correspondent of all active medical device establishments.
Your firm has an obligation to complete your Annual Registration for Fiscal Year (FY) 2010 between October 1, 2009 and December 31, 2009. Establishments required to pay must do so before completing their annual registration in the electronic device registration and listing system (FURLS).
When can I complete my FY 2010 annual registration?
You cannot complete your FY 2010 annual registration until after October 1, 2009. You may also not pay your FY 2010 annual registration fee, if required, until after October 1, 2009.
The electronic registration and listing system (FURLS) will be undergoing scheduled maintenance and will be unavailable to all users from September 28, 2009 through September 30, 2009. During this time you will be unable to register a new facility or make any updates to your firm's FY 2009 registration.
What is my account information to access the electronic registration and listing system?
Your account information is below. If you do not remember your password, please review the password reset instructions.
For information about the different types of accounts,please visit our website.
|Account ID||Account Type||Owner Operator
Are there any changes to the payment process for those firms required to pay?
For FY2010, the following changes have been made to the payment process.
- The device establishment registration user fee for FY2010 is $2008 per facility.
- If you pay the fee by paper check, the mailing address has changed.
- If you are a foreign establishment and you pay by wire transfer, you can find revised instructions on our website.
Information about these changes and the payment process can be found on our website.
(Reminder: establishments required to pay must do so before completing their annual registration.)
What if I still have questions or need help?
If you have any questions about your account or about device registration and listing, please contact us at firstname.lastname@example.org. For questions about paying the device establishment registration user fee, please send an email to email@example.com. Copies of this newsletter can be found on our website by going to the Registration & Listing Website and selecting the Documents link.
Chief, Regulatory Policy and Systems Branch
Division of Risk Management Operations
Office of Compliance
Center for Devices and Radiological Health