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U.S. Department of Health and Human Services

Medical Devices

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Communication to Firms Regarding Annual Registration for FY2009 (September 3, 2008)

TO: Official Correspondent

Device Establishment

This notice is being sent to:

  1. Remind you of your firm's obligation to complete your Annual Registration for Fiscal Year 2009 (FY 2009) between October 1, 2008 and December 31, 2008.
  2. Provide you with your current Account ID to access the electronic registration and listing system.
  3. Inform you that beginning October 1, 2008, you must pay your device establishment registration fee (if applicable) first, before completing your FY 2009 Annual Registration.

All medical device establishments must use the electronic registration and listing system (FURLS) to complete their FY 2009 Annual Registration no earlier then October 1, 2008 and no later than December 31, 2008. You will need your Account ID and Password that you used in FY 2008 to access FURLS. Please note that the electronic registration and listing system (FURLS) will not be available beginning 12 PM EST on Friday, September 26, 2008 until 5 PM EST on October 1, 2008.

Account Information

Your Account ID is:

If you do not remember the Password that you used in FY 2008, please review the Password reset instructions

Payment Information

The device establishment registration user fee for FY2009 is $1851 per facility. There are no reductions in annual establishment registration fees for small businesses or any other group.

If you are required to pay the device establishment user fee, beginning October 1, 2008, you must first visit the Device Facility User Fee (DFUF) website and pay the user fee(s) for those facilities. Credit cards, electronic checks and checks by mail will be accepted for payment. More information about this process can be found online. 

Annual Registration Information

Once you have paid your device establishment user fee (if required), log on to FURLS at https://www.access.fda.gov/oaa/ and select the Annual Registration link to complete your FY 2009 registration. If required to pay, you will be prompted during the Annual Registration process to provide the payment confirmation numbers (PIN/PCN) you received when you paid your FY 2009 establishment registration fee.

If you have any questions, please first visit our website. If you need more information, please send an email to reglist@cdrh.fda.gov.

Office of Compliance
Center for Devices and Radiological Health
U.S. Food and Drug Administration