On Oct. 26, 2002, the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), P.L 107-250, amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) to provide FDA new responsibilities, resources, and challenges. MDUFMA was signed into law.

In some instances, FDA has developed guidance that explains how we are interpreting and applying a particular MDUFMA provision or program.

Key Features of MDUFMA. MDUFMA has four particularly significant features:

• User fees for premarket reviews of PMAs, PDPs, premarket reports (a new category of premarket application for reprocessed single-use devices), BLAs, certain supplements, and 510(k)s.
• Performance goals for many types of premarket reviews. These goals become more demanding over time, and include FDA decision goals and cycle goals (cycle goals refer to FDA actions prior to our final action on a submission).
• Establishment inspections may be conducted by accredited persons (third-parties), under carefully prescribed conditions.
• New regulatory requirements for reprocessed single-use devices, including a new category of premarket submission, the premarket report.

The user fees authorized by MDUFMA are intended to add $25.1 million to FDA’s medical device budget authority during FY 2003, rising each year until fees amount to $35 million in FY 2007. These sums are protected from inflation and changes in workload and other factors through a set of adjustments. The revenues from these fees, and from additional appropriations, will allow FDA to pursue a set of ambitious performance goals; these goals are summarized in DHHS Secretary Thompson’s November 14, 2002 letter to Congress (referred to as the “FDA commitment letter”) and are incorporated by reference in MDUFMA. The payment of a premarket review fee is not linked in any way to FDA’s final decision on a submission.

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