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Passed in 1990, the SMDA has greatly broadened FDA authority over the medical devices industry. The act requires Medical Device Reports; not filing the reports can result in fines. The SMDA also formally changed the 510(k) procedure, which was originally intended to be a notification procedure, to a premarket approval procedure. The SMDA also permitted the assessment of substantial civil penalties for violating the Food, Drug, and Cosmetic Act relating to devices.
Publication Source: Committees on Human Research
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