What is the 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. MDUFMA was signed into law October 26, 2002. MDUFMA has three particularly significant provisions: • User fees for premarket reviews. PMAs, PDPs, BLAs, certain supplements, and 510(k)s are now subject to fees. The revenues from these fees, and from additional appropriations for infrastructure, will allow FDA to pursue a set of ambitious performance goals that will provide patients earlier access to safe and effective technology, and will provide more interactive and rapid review to the medical device industry. A small business (sales and receipts of $30 million or less) may pay a reduced fee. The payment of a premarket review fee is not related in any way to FDA’s final decision on a submission. • Establishment inspections may be conducted by accredited persons (third-parties), under c
