In Force Checked October 24, 2026
In force and unchanged by the QMSR.
What It Covers
What must be reported to FDA when a manufacturer or importer corrects or removes devices already in the field, and what must be recorded when no report is required.
Who It Applies To
Device manufacturers and importers.
Key Requirements
- A written report within 10 working days of starting a correction or removal made to reduce a risk to health, or to remedy a violation that may present a risk to health (§806.10).
- A record kept for corrections and removals that do not need reporting, with the reason (§806.20).
- Routine servicing, stock recoveries and market withdrawals are outside the reporting duty, but should be documented as such.
What an Auditor Asks to See
- The decision record for each field action: reportable or not, and why.
- Reports filed within 10 working days, with their content.
- Links between the field action, the CAPA, and the complaint trend that triggered it.
Where Systems Fall Short
- Field actions labeled “market withdrawal” without a documented health-risk assessment.
- No record kept for the actions that were judged not reportable.
How QES Helps
A field-action procedure that forces the health-risk decision and records it either way.
Related Standards
Sources. eCFR — 21 CFR Part 806 (opens in a new tab). Status checked October 24, 2026. This page summarizes 21 CFR Part 806; it does not reproduce or replace it. Buy the standard from its publisher, or read the regulation in its official text, before relying on a detail. Not legal advice.