Maps to
21 CFR Part 806: §806.10 Reports of corrections and removals.
Requirement text
Device manufacturers and importers must submit a written report to FDA of any correction or removal of a device initiated by such manufacturer or importer if the correction or removal was initiated (1) to reduce a risk to health posed by the device, or (2) to remedy a violation of the Federal Food, Drug, and Cosmetic Act caused by the device which may present a risk to health, unless the information has already been provided as set forth in 806.10(f) or the corrective or removal action is exempt from the reporting requirements under 806.1(b). Reports must be submitted within 10 working days of initiating the correction or removal and must include specified information about the device, the event giving rise to the action, distribution data, and consignee information.