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U.S. Department of Health and Human Services

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MDUFMA I (FY 2003 through FY 2007)

FY 2009 MDUFA Performance Report Table of Contents

On October 26, 2002, MDUFMA I was signed into law. [3] MDUFMA I amended the FD&C Act authorizing FDA to collect fees from companies who submit certain applications for marketing of medical devices. In return, MDUFMA I required FDA to pursue a comprehensive set of device review performance goals that were intended to significantly improve the timeliness and predictability of FDA’s review of new devices. A limited number of goals were applied during FY 2003 and FY 2004, allowing FDA time to hire staff, build infrastructure, provide guidance to industry, and take other actions. Consequently, most of the substantive review performance goals went into effect in FY 2005. Additional goals were added in FY 2006 and again in FY 2007, with the goals becoming more demanding each year.

On April 1, 2004, MDUFMA I was amended and expanded by the Medical Device Technical Corrections Act (MDTCA), Public Law (P.L.) 108-214. MDTCA amended MDUFMA I to clarify Congress’ intent and to improve and expand upon some features of MDUFMA I. On August 1, 2005, the Medical Device User Fee Stabilization Act of 2005 (the “Stabilization Act”), P.L. 109-43, amended provisions of the FD&C Act relating to medical device user fees and device labeling; however, these changes did not affect the performance goals FDA pursued under MDUFMA I.

[3] See the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), P.L. 107-250 (October 26, 2002).

Next page: MDUFA II (FY 2008 through FY 2012)