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All medical device Companies need to be aware of these changes from the FDA concerning the new user fees.

Important Information on Device Facility User Fee & Registration

A New Way of Processing Effective October 1, 2008 (FY 2009)

On October 1, 2008, the United States Food and Drug Administration (USFDA) will introduce an improved process for collecting device facility (also known as "establishment") user fees and registrations. The most significant change in the process will be that you must pay your user fee before you register your facility. In other words, you cannot register until you pay your user fee (if applicable). Additional information can be found on FDA’s website at:
http://www.fda.gov/cdrh/mdufma/FY09UserFeeReg.pdf

Important Information on the Medical Device User Fee Rates for FY 2009 Submissions

The United States Food and Drug Administration (USFDA) has published the fee rates and payment procedures for medical device user fees for fiscal year 2009 (October 1, 2008-September 30, 2009). The Federal Food, Drug, and Cosmetic Act (FD&C), as amended by the Medical Device User Fee Amendments of 2007 ("the 2007 Amendments") authorizes FDA to collect user fees for certain medical device applications. Additional information can be found on FDA’s website at:
http://www.fda.gov/cdrh/mdufma/FY09UserFee.pdf

A 4 page letter addressing the above changes has also been mailed to your Owner Operator and to all identified Official Correspondents. If they have not received this letter by September 12, 2008, you may advise USFDA at dsmica@fda.hhs.gov with the complete mailing address for the recipient.

For more information on this please contact mdi at info@mdiconsultants.com.

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