Update Aug 12, 05Medical
Device User Fee Rates for Fiscal Year
(FY) 2006
The Food and Drug Administration (FDA) is announcing the fee rates
and payment procedures for medical device user fees for the fiscal year
2006. The Federal Food, Drug, and Cosmetic Act, as amended by the
Medical Device User Fee and Modernization Act of 2002 (MDUFMA) and the
Medical Device User Fee Stabilization Act of 2005 (MDUFSA) authorizes
FDA to collect user fees for certain medial device applications.
For all applications submitted on or after October 1, 2005 and
through September 30, 2006, fees must be paid at the FY 2006 rates. Fee
is assessed based on the date when the application is received by the
FDA or the date when the check is received, whichever is later.
To qualify for the Small Business fee, the firms’ annual gross sales
or receipts should be $30 million or less, and this includes gross sales
and receipts of all affiliates, partners, and parent firms. Firms should
apply for this qualification at least 60 days before they intend to
submit their application and fee. Also, even if a firm qualified under
the act as a small business for MDUFMA fees in FY 2005, it must obtain a
new small business certification and decision number for FY 2006 and for
each subsequent FY.
Medical Device User Fee Rates for FY 2006
For more information on the FDA User Fees contact the FDA at
www.fda.gov/cdrh/mdufma or mdi at
Userfees@mdiconsultants.com.
If any questions on the report or comments please email us at
info@mdiconsultants.com.
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