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U.S. Department of Health and Human Services

For Industry

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Medical Device User Fee and Modernization Act (MDUFMA)

The Medical Device User Fee and Modernization Act of 2002 (MDUFMA), P.L. 107-250, amended the Federal Food, Drug, and Cosmetic Act to provide:

  • User fees for device reviews;
  • New provisions allowing establishment inspections to be conducted by accredited persons (third-parties);
  • New regulatory requirements for reprocessed single-use devices.

On September 27, 2007, the President signed an act reauthorizing medical device user fees for fiscal years 2008 - 2012. The legislation — the Medical Device User Fee Amendments of 2007 — is part of a larger bill — the Food and Drug Administration Amendments Act of 2007 (H.R. 3850) — that affects many other FDA programs.

For more information about MDUFMA, please see Medical Device User Fees.