The U.S. Food and Drug Administration (FDA) proposed recommendations to Congress for reauthorizing the Medical Device User Fee and Modernization Act (MDUFMA).
Under the MDUFMA program, industry covers a portion of the costs of FDA's premarket review program through various fees. The fees are used in concert with the agency's annual appropriations to help FDA meet its review performance goals, which the agency said would allow it to bring more promising products to market.
The industry user fees represent less than a quarter of the overall device budget for MDUFMA, according to the FDA.
In related news, the Medical Imaging and Technology Alliance (MITA), a division of the National Electrical Manufacturers Association (NEMA) of Rosslyn, VA, stated that it believes that the FDA needs the resources to review products and that it hopes that Congress will concur.
The FDA said it is accepting public comments on the proposal for the next 30 days and is holding a public meeting on April 30.
By AuntMinnie.com staff writers
April 17, 2007
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