What is the Medical Device User Fee and Modernization Act of 2002 (MDUFMA)?
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 October 26, 2002. MDUFMA has three particularly significant provisions: • It establishes fees for premarket reviews of medical devices; • It permits establishment inspections by accredited persons (third-parties); and • It provides new regulatory requirements for reprocessed single-use devices.
