U.S. Food and Drug Administration

Medical Device User Fee and Modernization Act of 2002

The Act

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. MDUFMA was signed into law Oct. 26, 2002. MDUFMA has three particularly significant provisions:

  • User fees for device reviews.
  • Establishment inspections may be conducted by accredited persons (third-parties),
  • New regulatory requirements for reprocessed single-use devices.

Summary of the Law
PDF (67.6 KB)

Complete Text of the Law
PDF (172 KB)

Bill Summary

Performance Goals
PDF (72.2 KB)

Medical Device User Fee Stabilization Act of 2005
PDF (50 KB)




FY 2007 MDUFMA Performance Report
PDF (558 KB)

FY 2007 MDUFMA Financial Report
PDF (269 KB)

Report Archives

More MDUFMA Information

Other User Fee Information


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