FDA 21 CFR Part 821 Medical Device Tracking Requirements

FDA 21 CFR Part 821 Medical Device Tracking Requirements:

FDA 21 CFR Part 821 Medical Device Tracking Requirements: The regulations in this part implement section 519(e) of the Federal Food, Drug, and Cosmetic Act (the act), which provides that the Food and Drug Administration may require a manufacturer to adopt a method of tracking a class II or class III device, if the device meets one of the following three criteria and FDA issues an order to the manufacturer.

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FDA 21 CFR Part 821 Medical Device Tracking Requirements:

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