FDA 21 CFR Part 806 Medical Device Corrections & Removals

21 CFR Part 806 is the FDA regulation that requires medical device manufacturers and importers to maintain records and, in certain cases, submit reports when they initiate a correction or removal of a device to reduce a health risk or remedy a violation that may present a risk to health. It is a key post-market compliance requirement tied to field actions.

A 21 CFR 806 report is the formal submission made to FDA when a manufacturer or importer undertakes a reportable correction or removal. It typically includes device identification, the reason for the action, dates, quantity affected, distribution details, and an explanation of the health risk or regulatory issue being addressed. Even non-reportable actions still require proper records in many cases.

FDA 806 guidance helps manufacturers interpret when a correction or removal must be reported, what records must be maintained, and how to distinguish reportable field actions from routine servicing or stock recovery. It supports consistent decision-making, but companies still need a documented, case-specific regulatory rationale based on the facts, risk profile, and applicable post-market obligations.

A correction or removal becomes reportable when it is initiated to reduce a risk to health posed by the device or to remedy a violation of the FD&C Act caused by the device that may present a risk to health. The decision should be based on documented risk evaluation, device performance issues, complaint data, and the nature of the field action—not just internal business preference.

No. Some actions may be exempt from reporting, such as routine servicing or certain stock recoveries, depending on the facts and regulatory context. However, exempt does not mean undocumented. Manufacturers still need clear records showing why the action was considered non-reportable, what devices were affected, and how the decision was reached in case FDA reviews the file later.

Manufacturers should maintain records that identify the device, describe the issue, explain the correction or removal, document dates and quantities, show where affected units were distributed, and capture the rationale for whether the action was reportable. These records should also align with complaint files, CAPA records, risk management documentation, and any related FDA correspondence to support inspection readiness.

Part 806 does not operate in isolation. A correction or removal often originates from complaint trends, adverse events, nonconformances, or CAPA investigations. In some cases, the same underlying issue may also trigger Medical Device Reporting obligations under 21 CFR Part 803. The key is ensuring your complaint handling, CAPA, risk management, and field action documentation tell one consistent and defensible compliance story.

Yes. Experienced regulatory consultants can help assess reportability, prepare the 806 submission if needed, organize supporting records, and align the action with complaint, CAPA, and risk files. This reduces the chance of inconsistent documentation, missed reporting obligations, or weak justifications that could create problems during FDA follow-up, inspections, or broader post-market reviews.