FDA 21 CFR Part 806 Medical Devices: Reports Of Corrections and Removals

FDA 21 CFR Part 806 Medical Devices: Reports Of Corrections and Removals:

FDA 21 CFR Part 806 Medical Devices: Reports Of Corrections and Removals: This part implements the provisions of section 519(g) of the Federal Food, Drug, and Cosmetic Act (the act) requiring device manufacturers and importers to report promptly to the Food and Drug Administration (FDA) certain actions concerning device corrections and removals, and to maintain records of all corrections and removals regardless of whether such corrections and removals are required to be reported to FDA.

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FDA 21 CFR Part 806 Medical Devices: Reports Of Corrections and Removals:

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