Medical Devices; Reports of Corrections and Removals

The information collection requirements in 21 CFR Part 806 require each device manufacturer or importer to submit a written report to FDA of any action to correct or remove a device which may present a risk to health within 10-working days of initiating such correction or removal. The Information Collection also requires that each device manufacturer or importer of a device who initiates a correction or removal of a device that is not required to be reported to FDA, shall keep a record of such correction or removal.

The latest form for Medical Devices; Reports of Corrections and Removals expires 2023-10-31 and can be found here.

Device corrections and removals

Federal Enterprise Architecture: Health - Consumer Health and Safety