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U.S. Department of Health and Human Services

Medical Devices

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April 2008 Letter to Firms Who Did not Fulfill Their Annual Registration and Listing Requirements for Fiscal Year 2008 - Version 2

April 14, 2008


TO: Official Correspondent of [Name of device establishment], Ref. No. [Insert establ. regis. #]
RE: Registration and Listing with the Food and Drug Administration


We are writing to you concerning your obligation to submit annual registration and listing information to the Food and Drug Administration (FDA) on behalf of your establishment as required by section 510 of the Federal Food, Drug, and Cosmetic Act (the Act)(21 U.S.C. 360). As you may know, in September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (FDAAA)(Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means during the period beginning on October 1st and ending on December 31st of each year1. As a result of this new law, annual registration and listing for fiscal year 2008 was required to have been completed by December 31, 2007.

Our records indicate that you have not yet fulfilled your annual registration and listing requirements for fiscal year 2008. As the owner, operator, or official correspondent of a device establishment that is required to register with FDA, we request that you register your establishment with FDA within thirty (30) working days from the date of this letter. You can access FDA’s Internet site at http://www.access.fda.gov/oaa/ to submit your registration and listing information. If you require assistance, contact the registration staff at: reglist@cdrh.fda.gov. You must register and list electronically unless you can show that using the Internet to register and list is not reasonable for you and FDA grants your request for a waiver. Information about how to request a waiver from electronic registration and listing is available on-line, or you may contact our office at 240-276-0110.

We request that you reply to us in writing within ten (10) working days from the date of this letter if you will not be able to complete your establishment's annual registration and listing obligations within the timeframe specified in this letter. In your reply, please inform us of the specific reasons for the delay in registering with FDA. Please send your reply to:

Terry McDonald
Center for Devices and Radiological Health
Office of Compliance
9200 Corporate Boulevard, HFZ- 307
Rockville, MD 20850.

Please be advised that the failure to register your establishment within thirty (30) working days from the date of this letter may result in your establishment being removed from FDA's database of active registrants without any further notice to you. If you have any questions about this letter, you may call this office for assistance at 240-276-0110.

Sincerely yours,

Timothy A. Ulatowski
Director
Office of Compliance
Center for Devices and
Radiological Health

 


 1Establishment registrations are based on FDA's fiscal year, which runs from October 1 through September 30. Section 510 of the Act, as amended by FDAAA, requires annual registration and listing information to be submitted during the first 3 months of each fiscal year (i.e., October 1 to December 31).