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FY 2003 PERFORMANCE REPORT TO CONGRESS

for the

Medical Device User Fee and Modernization Act of 2002

Food and Drug Administration
Department of Health and Human Services

Commissioner's Report

Twenty-first century technology is creating new medical devices at an unprecedented pace and has challenged FDA's ability to keep apace with timely review of safety and effectiveness, to ensure that patients have early access to new medical devices. Last year, Congress passed the Medical Device User Fee and Modernization Act (MDUFMA), providing the added resources needed to ensure that FDA can provide that rapid review. In return for these user fees, FDA is pursuing a comprehensive set of device review performance goals that will significantly improve the timeliness and predictability of FDA's review of new device applications. This report identifies what we expect to accomplish under MDUFMA and presents our accomplishments for the first year of MDUFMA.

MDUFMA authorizes FDA to do the following:

• Collect user fees for premarket reviews of medical device applications.
• Accredit persons (third-parties) to conduct establishment inspections, under carefully prescribed conditions.
• Require new regulations for reprocessed single-use devices, including the submission of additional data on devices now being reprocessed, and a new category of premarket submission, the premarket report.

FDA met or exceeded all of MDUFMA's FY 2003 commitments and initiative expectations. In addition, we published and developed guidances for industry and FDA staff, hired additional staff, and initiated outreach efforts to stakeholders. While this first year of the program was primarily one of transition, and we still have some building blocks to put in place, I am proud to say we are off to a great start.

As we implement MDUFMA, we are applying the best biomedical science and risk management. Determining whether products are safe and effective in the least costly and burdensome manner translates into lower costs for innovating and more new products for more patients. MDUFMA will help bring innovative, affordable products to the market quickly, without compromising product safety and efficacy and help FDA fulfill our increasingly complex public health mission.

Mark B. McClellan, M.D., Ph.D.
Commissioner of Food and Drugs

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