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MDUFMA |
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Alliance maintains stringent requirements set forth by MDUFMA and welcomes all regulatory framework that protects patient populations. MTC), (OTCBB:MDSC) of Cherry Hill, New Jersey, a developer of imaging technology for molecular detection of cancer and physiological change, announced: on December 11, 2003 the FDA, after review, qualified the Company under MDUFMA (The Medical Device User Fee and Modernization Act of 2002) allowing both reduced or waived FDA fees for its 2004 medical device 510K market approval submissions. Our session at MD&M West will present an overview of MDUFMA, which includes a summary that is intended to describe three key provisions of the new law: 1) user fees for pre-market reviews; 2) establishment inspections by accredited third parties; and 3) new regulatory requirement for reprocessed single use devices. |
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