Full device user fee chart and guidance reprinted from "The Gray Sheet" - August 10, 2009
Medical Device User Fees and Guidance - FY 2010 - DOWNLOAD THE FREE 40-PAGE PDF
FDA published its fiscal year 2010 fees for pre-market submissions and other regulatory filings Aug. 3, plus guidance for small businesses in the U.S. and abroad with updated certification instructions. The new fees reflect an across-the-board 8.5% increase over fiscal 2009, in accordance with the FDA Amendments Act of 2007. The rates apply from Oct. 1, 2009, through Sept. 30, 2010.
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