21 CFR Part 806 – Medical Device Corrections & Removals

This topic is part of the SG Systems Global regulatory glossary series.

Updated October 2025 • FDA / QSR • Field Action & Recall Management

21 CFR Part 806 defines the FDA requirements for medical-device corrections and removals — actions taken to reduce a risk to health or address regulatory non-compliance. It ensures that manufacturers, importers, and distributors report significant field actions and document all corrections for traceability and patient safety.

“Every field action — from label updates to recalls — must be recorded, evaluated, and reported under Part 806 when public health could be impacted.”

1) What It Is

Part 806 operationalizes Section 519 of the FD&C Act to track and control field actions for medical devices. It requires written records of all corrections and removals and submission to FDA if the action was initiated to reduce a risk to health or to remedy a violation that may present a health risk.

Scope & application. Applies to all U.S. medical-device manufacturers, importers, and distributors. Hospitals and clinics are excluded unless acting as manufacturers or reprocessors.

Selected requirements under Part 806:

• 806.10 Reporting requirements. Notify FDA within 10 working days of initiating a correction or removal for health risk or non-compliance.
• 806.20 Recordkeeping. Maintain records of all field actions — including rationale, risk assessment, and correspondence — for 2 years beyond device life.
• 806.40 Availability for inspection. All records must be readily accessible to FDA inspectors under Part 820.
• Exemptions & distinctions. Market withdrawals or routine servicing are not reportable if not health-risk related.

Relation to other rules. Closely linked with Part 803 (MDR), Part 820 (QSR/CAPA), and Part 11 (Electronic Records & Signatures).

2) FAQ

Q1. What is a “correction” vs “removal”?
A correction is a fix to a device still in the market (e.g., software update); a removal is physically retrieving the product from the field.

Q2. When must FDA be notified?
Within 10 working days if the action was taken to reduce a health risk or correct a violation posing a health hazard.

Q3. What records must be kept?
Written justifications, risk evaluations, copies of correspondence, distribution lists, and follow-up results of corrective actions.

Q4. Are software updates reportable?
Only if they are initiated to reduce a risk to health or correct a non-compliance that could affect safety or performance.

Q5. How does Part 806 relate to MDR (Part 803)?
MDR addresses event reporting; Part 806 addresses the manufacturer’s field response once a risk is identified.

Q6. Where is the official text?
See the eCFR for 21 CFR Part 806.

3) How It Relates to V5

V5 by SG Systems Global helps device manufacturers comply with Part 806 by integrating field action tracking, CAPA, and electronic sign-off within the Quality Management System (QMS).

• Field action workflow. Create and track correction/removal records linked to MDR or CAPA events.
• Electronic approvals & audit trail. Part 11 signatures record authorization and submission timelines.
• Device traceability. Integrate with eDHR to identify affected lots or serial numbers.
• CAPA integration. Corrections trigger root-cause investigations under Part 820 QSR.
• Automated records retention. Archived digitally for inspection readiness under Part 806 and 820.

End-to-end example. A firm discovers a potential labeling error; QA initiates a V5 correction record linked to the affected lots; CAPA is opened for root cause; corrective labels are issued with Part 11 sign-offs and all records archived for FDA review.

Primary References:
• FDA eCFR: 21 CFR Part 806
• Related Rules: Part 803 (MDR) | Part 820 (QSR) | Part 11