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Medical devices must receive FDA approval before being marketed (since the 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act). Similar to an IND, an IDE allows companies to sell and use a limited number of devices for investigation purposes and clinical trials. The IDE exempts the device not only from the pre-market approval regulation but also from a host of other reporting and recording regulations. The Amendments divided medical devices into three classes.
Publication Source: Committees on Human Research
See also: Class
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