FDA’s Registration and Listing requirements for FY 2010

The following information was sent out to all US Agents and Official Correspondents to notify the companies and clients as to what would be required for the FY 2010 Registration and device listing requirements.

This information is about the Fiscal Year (FY) 2010 annual device establishment registration and listing cycle which begins on October 1, 2009.

Who must complete an annual device establishment registration?
Establishments that are involved in the production and distribution of medical devices intended for commercial distribution in the United States are required to register annually with the FDA.

When do I complete the FY 2010 annual device establishment registration?
All device establishments must complete their annual registration for FY 2010 between October 1, 2009 and December 31, 2009.

How much is the registration user fee for FY 2010?
If your establishment is required to pay, the fee amount for FY 2010 is $2008 per establishment. There are no small business reductions for this fee.

What information should I know before starting the FY 2010 annual registration?

• Your account ID and password for the electronic registration and listing system (FURLS). If you need assistance with your FURLS account ID or password, send an email to reglist@cdrh.fda.gov. Provide us with your account ID (if known) or your registration number and owner operator number.
• Your establishment type (for example: manufacturer, specification developer, etc.). The user fee is based on the establishment type that you certify in FURLS.
•  If you are required to pay the fee, your username and password for FDA's User Fee system. This is different from your account ID and password for FURLS. Establishments required to pay the fee must pay before they can submit their annual registration. If you need assistance with your User Fee system username and password, send an email to userfees@fda.gov or call (301) 827-9539.
• Devices that you want to add, change or remove from your active listings. Know the FDA clearance/approval number if you want to add a new listing for a device that has received premarket clearance/approval. If you are no longer commercially distributing a device in the U.S., you should deactivate that listing.

What if I still have questions or need help?
Information on how to complete annual registration is found at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053185.htm
If you have questions about device registration and listing, contact us at reglist@cdrh.fda.gov.

If you need assistance with your Annual FDA Registration and Listing requirements you can contact mdi Consultants at info@mdiconsultants.com and reference Reg/List for 2010.