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FDA Recommends Medical Device User Fee Program - Monday, September 17, 2007

The FDA has proposed a recommendation to Congress for reauthorizing the Medical Device User Fee and Modernization ACT (MDUFMA), which would help to ensure that safe and effective medical devices get to patients in a timely fashion. Under this program, industry covers a portion of the costs of the FDA's pre-market review program through a variety of fees. The additional revenues generated from the fees paid by the medical device industry would continue to be used to ensure patients have timely access to safe and effective medical devices.

This proposal, if adopted, would foster the development of innovative in vitro diagnostic tests by issuing new industry guidance on emerging issues and reviewing some low-risk devices to determine whether any of them could be exempted from the need for product review.

The Medical Device User Fee and Modernization Act of 2002, which expires on September 30, 2007, amended the federal Food, Drug and Cosmetic Act to provide the FDA with new responsibilities and resources to keep with the rapidly growing device industry and advancing medical device technology.