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 that was initiated to reduce a risk to health posed by the device, or to remedy a violation of the Federal Food, Drug, and Cosmetic Act that may present a risk to health. 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.