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August 22, 2008 

FDA Increases Medical Device Registration Fees

The U.S. Food and Drug Administration (FDA) has announced in the Federal Register new registration fee amounts and payment procedures for medical devices for fiscal year (FY) 2009.

These changes, which were authorized by the Medical Device User Fee Amendments of 2007, will impact medical devices that are imported into the U.S. This is because foreign establishments engaged in the manufacture of medical devices imported into the U.S. must register their establishments and provide the FDA with the name of the U.S. agent representing their establishment.

The FDA's Establishment Registration Fee for medical device manufacturers will be $1,851 for FY 2009, an increase from $1,706 in FY 2008.

The FDA also announced that registration payments must be received on or before the time of submission. Previously, a medical device manufacturer could register its establishment and submit a subsequent payment. Under the new process, a company cannot register until it pays the $1,851 fee. Companies can pay online, or submit a check issued by a U.S. bank. Additional instructions for establishment registrations are available here on the FDA's website.

All annual establishment registration fees for FY 2009 must be submitted to FDA between October 1, 2008 and December 31, 2008.




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