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Removal vs Correction (21 CFR 806)
Reporting categories for field actions: removal physically retrieves the device; correction modifies it in place.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed September 19, 2026
Definition
Manufacturers must report to FDA within 10 working days corrections or removals initiated to reduce health risk or remedy violations. Some actions are exempt (e.g., normal service, market withdrawal not for safety/violation). A correction is the repair, modification, adjustment, relabeling, destruction or inspection of a device without physically removing it from where it is used; a removal is moving it to another location for those actions. Reports go to the FDA district office and must include specific information listed in 21 CFR 806.10. Actions that are not reportable must still be recorded, with the reason, under 806.20. What the regulation says
Under 21 CFR Part 806, manufacturers are mandated to report to the FDA certain corrections and removals of medical devices. This regulation distinguishes between actions taken to reduce a health risk posed by a device or to remedy a violation of the FD&C Act, and routine servicing or minor market withdrawals not related to safety or compliance concerns.What this means in practice
806 reporting is separate from recall classification; the two systems intersect but have distinct triggers and timelines.Examples
- A manufacturer discovers a software bug that could cause inaccurate therapy delivery and issues a software update to all installed devices, this would be a correction.
- A medical device company recalls a batch of sterilization pouches after discovering a breach in sterility, leading to the physical retrieval of the products from distributors and hospitals, this is a removal.
- A company identifies a labeling error on an in vitro diagnostic (IVD) kit that could lead to incorrect test interpretations and sends corrected labels and instructions to all customers without retrieving the kits, this constitutes a correction.
Common pitfalls
- •A common pitfall is misunderstanding the reporting criteria, leading to underreporting or overreporting of events to the FDA.
- •Manufacturers often incorrectly assume that all product withdrawals constitute a reportable removal under 21 CFR Part 806.
- •Failing to initiate appropriate corrective and preventive actions (CAPA) following a reported correction or removal can lead to repeat issues and regulatory scrutiny.
- •Not adequately documenting the decision-making process for whether an action is a correction or removal, or an exempt activity, can result in compliance deficiencies.
- •Confusing the reporting requirements of 21 CFR Part 806 with Medical Device Reporting (MDR) under 21 CFR Part 803 can lead to incorrect submissions and timelines.
Frequently asked questions
A removal involves the physical removal of a device from its point of use or sale, while a correction involves modification, inspection, or repair of a device without its physical removal. Both are initiated to address health risks or regulatory violations.
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Sources
3 sourcesSources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
Tier 1Binding law and standards· 1Tier 2Regulator guidance and consensus· 2
Link health: 3 verified· last checked 2026-06-20
eCFR·1FDA·1European Commission·1
- 121 CFR 806Tier 1 VerifiedeCFRecfr.gov
- 2FDA Recalls - Medical DevicesTier 2 VerifiedFDAfda.gov
- 3EUDAMED Public SiteTier 2 VerifiedEuropean Commissionec.europa.eu
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