Medical Devices; Reports of Corrections and Removals
The FDA regulation requiring device manufacturers and importers to report corrections and removals undertaken to reduce a risk to health, or to remedy a violation of the FD&C Act that may present a risk to health — within 10 working days of initiating the action. Corrections and removals that do not meet the reporting threshold must instead be recorded and the records kept available to FDA. Part 806 is the postmarket duty that sits between Part 803 adverse-event reporting and the recall framework of 21 CFR Part 7.
What this does not cover
stated in the document's own scope- Covers corrections and removals undertaken for risk-to-health reasons; actions within the §806.1(b) exemptions — such as routine servicing and stock recoveries — are outside the reporting duty.
- A reporting and records rule: the classification and conduct of recalls follows FDA's recall framework in 21 CFR Part 7.
- Distinct from Part 803: an adverse event and the corrective field action it triggers are separate reportable facts under separate parts.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
21 CFR Part 806 requires device manufacturers and importers to tell FDA when they take field corrective action for safety reasons: any correction or removal initiated to reduce a risk to health, or to remedy a violation of the FD&C Act that may present a risk to health, must be reported within 10 working days of initiating the action. A correction is action taken on a device at its point of use — repair, modification, relabeling, or inspection; a removal physically relocates the device to correct it. Corrections and removals below the reporting threshold are not filed with FDA but must be recorded, with the records kept for FDA review. The part is the transparency mechanism that sits between Part 803 adverse-event reporting and the recall framework of Part 7.
Scope & applicability
Manufacturers and importers of medical devices distributed in the US that initiate a correction (repair, modification, relabeling, inspection at the device's location) or removal (physical removal to another location). Exemptions in §806.1(b) include routine servicing and stock recoveries.
Legal basis & how it acquires force
A regulation issued under section 519(g) of the FD&C Act, which directs reports of device corrections and removals, implemented by FDA in 1997 as Part 806 of subchapter H. Exemptions in §806.1(b) carve out actions such as routine servicing and stock recoveries. Compliance is enforced through the device postmarket inspection programme alongside Parts 803 and 820/QMSR.
Document structure
| Part | Covers |
|---|---|
| Subpart A — General provisions | Scope, the correction and removal definitions, and the §806.1(b) exemptions |
| Subpart B — §806.10 Reports of corrections and removals | The 10-working-day report, its required content, and amendment when the action extends to further lots |
| Subpart B — §806.20 Records of non-reported actions | The records kept for corrections and removals that do not meet the reporting threshold |
| Interfaces with Part 7 and Part 803 | How reported actions relate to the recall classification framework and to adverse-event reporting |
Key requirements
- Report qualifying corrections and removals to FDA within 10 working days of initiating the action
- Report content covering the device, the reason for the action, and the distribution and communication details
- Amend the report within 10 working days when the action extends to additional lots or batches
- Keep records of corrections and removals not required to be reported, available for FDA review
Implementation tips
- Wire the 10-working-day clock into the CAPA/field-action workflow — the trigger is initiating the action, not completing the health-hazard evaluation, and the documented risk decision is what supports a not-reportable call
Revision notes
Issued in 1997 and stable since in substance; it operates alongside Part 7 (recall policy and procedures) and Part 803 (medical device reporting).
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
Part 806 completes the US device postmarket triad: Part 803 reports what the device did (deaths, serious injuries, malfunctions), Part 806 reports what the firm did about risk (corrections and removals), and Part 7 supplies the recall policy and classification machinery FDA applies to the action. The EU parallel is the field safety corrective action and field safety notice regime of the MDR and IVDR vigilance provisions.
21 CFR Part 806: frequently asked questions
Quick answers to common questions about 21 CFR Part 806.
What deadline applies to a Part 806 report?
The manufacturer or importer must submit the report within 10 working days of initiating the correction or removal, and must amend it within 10 working days if the action is extended to additional lots or batches.
What is the difference between a correction and a removal?
A correction is action taken on the device where it is used or held — repair, modification, adjustment, relabeling, or inspection. A removal means physically moving the device to some other location for the corrective action. Both are reportable when done to reduce a risk to health.
Are all corrections and removals reportable?
No. Only those initiated to reduce a risk to health, or to remedy an FD&C Act violation that may present a risk to health. Non-reportable corrections and removals must instead be recorded under §806.20, and §806.1(b) exempts categories such as routine servicing and stock recoveries entirely.
How does Part 806 relate to recalls under Part 7?
Part 806 is the reporting duty; Part 7 is the recall framework. A reported correction or removal is typically evaluated and classified by FDA under Part 7's recall machinery, and the firm's conduct of the recall follows that part's policy and procedures.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.