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U.S. Department of Health and Human Services

Medical Devices

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FDA Device Establishment Registration and Listing Newsletter - September 2010

The following information is for the Registration/Listing Period of FY2011. Registration information must be submitted each year between October 1 and December 31, even if no changes have occurred. Listing information must be reviewed at the same time you review your registration information.

Firms that are required to pay must visit the Device Facility User Fee (DFUF) Website and pay the user fee for FY 2011 before logging onto the electronic registration and listing system known as the FDA Unified Registration and Listing System (FURLS).

Once your payment has been received and processed and you have received your Payment Identification Number (PIN)/Payment Confirmation Number (PCN), please log onto the FURLS Registration & Listing System using your FURLS Account ID and Password to complete your annual registration. FURLS can be found at https://www.access.fda.gov/oaa/.

You will receive an email with your FURLS Account ID shortly. If you do not receive the email or do not know your FURLS ID or Password, please send an email to reglist@cdrh.fda.gov immediately.

The Registration & Listing System (FURLS) will be down for scheduled maintenance starting noon on Tuesday, September 28 th until 8:00am on Friday, October 1st, 2010. You will not be able to register your firm, update your firm’s registration or complete your annual registration during this time.

Copies of this newsletter can be found by selecting the Document link on the Registration and Listing website listed below:

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ HowtoMarketYourDevice/RegistrationandListing/default.htm.

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