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U.S. Department of Health and Human Services

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FY 2002 ODE Annual Report - Part 4 - Major Program Initiative

Medical Device User Fee and Modernization Act of 2002

The Medical Device User Fee and Modernization Act of 2002 (MDUFMA), P.L. 107-250, amends the Federal Food, Drug, and Cosmetic Act to provide FDA important new responsibilities, resources, and challenges. FDA expended a great deal of effort in the preparation of MDUFMA during this fiscal year, and it was signed into law October 26, 2002. Negotiations began in the Spring 2002, and ODE and other Offices within CDRH worked with CBER, ORA, and the Office of the Commissioner, as well as our stakeholders, to make this legislation a reality. Key provisions include:

  • User fees for premarket reviews, with significant performance goals to timeliness of reviews.
  • Establishment inspections by accredited persons (third-parties).
  • New regulatory requirements for reprocessed single-use devices.

More detailed information on the new law is available on CDRH Internet site.