United States (FDA)
21 CFR Part 806: Reports of Corrections and Removals
When a manufacturer or importer corrects or removes devices already in the field, Part 806 decides whether FDA must be told. Some field actions must be reported; others only need a record explaining why they were not. Both sides of that decision are reviewed on inspection.
At a Glance
- Regulation
- 21 CFR Part 806
- Subject
- Reports of Corrections and Removals
- Group
- United States (FDA)
- Industries
- 10 industry guides reference it
A plain-language summary, not legal advice. Always read the current official text.
What It Covers
A correction is the repair, modification, adjustment, relabeling, destruction or inspection of a device without moving it from where it is used or sold. A removal is the physical movement of a device to another location for any of those purposes. Part 806 requires manufacturers and importers to report a correction or removal to FDA if it was initiated to reduce a risk to health posed by the device, or to remedy a violation of the Federal Food, Drug, and Cosmetic Act caused by the device that may present a risk to health.
Not every field action is reportable. The regulation excludes certain actions, such as market withdrawals, routine servicing and stock recoveries, and actions already reported to FDA under another requirement. For corrections and removals that are not reported, the firm must still keep a record that includes the reason the action was not reported, so the decision can be reviewed later.
Part 806 sits next to FDA's recall policies and procedures, which address how recalls are classified and conducted. Corrections and Removals is one of the other applicable FDA requirements named in Compliance Program 7382.850. Investigators often reach it through CAPA, complaint trends and nonconforming product records, looking for field actions the firm did not recognize as such.
Who It Applies To
- Device manufacturers, including foreign manufacturers of devices marketed in the United States
- Importers of devices into the United States
- Firms that relabel, rework or retrofit devices already distributed
- Software device makers pushing fixes to products in the field, where the update is made to reduce a risk to health
What Auditors Check
Field Action Identification
Whether the firm recognizes corrections and removals when they happen, including software patches, labeling updates and service bulletins that change devices in the field.
Reportability Decisions
A documented assessment of whether each action was taken to reduce a risk to health or remedy a violation, and a reasoned conclusion on whether it was reportable.
Records of Non-Reported Actions
For actions the firm decided not to report, a record that includes the justification. Missing records here are a frequent gap.
Links to CAPA and Complaints
Investigators trace from CAPAs, complaint trends and nonconformances to see whether any of them led to a field action that should have been evaluated under Part 806.
Distribution Records and Effectiveness
Whether the firm could identify affected units and customers, and how it confirmed the action reached them.
Related Services
FDA Inspection Readiness (CP 7382.850)
FDA device inspection preparation built around Compliance Program 7382.850 and its risk-based approach.
CAPA System Remediation
Fixing a CAPA system auditors keep citing: the procedure, the records, root cause, effectiveness and backlog.
Warning Letter Response and Remediation
A thorough, systemic response to an FDA warning letter, and the remediation and updates that follow it.
Industry Guides That Reference 21 CFR Part 806
Questions
Is every recall a Part 806 report?
Not exactly. Part 806 covers corrections and removals initiated to reduce a risk to health or remedy a violation that may present a risk to health, and many such actions are also handled as recalls. Some actions, like routine servicing or a market withdrawal, are excluded from reporting. The classification of a specific action depends on its facts.
What do we need if we decide not to report?
You still need a record of the correction or removal that includes the reason it was not reported. Investigators may review that justification, so it should explain the risk assessment rather than state a conclusion. Keeping these records in one place makes them easy to produce.
Does a software update count as a correction?
It can. A change made to devices already in the field is a correction if it modifies or adjusts the device, and it is reportable if it was made to reduce a risk to health. Software changes should go through the same Part 806 evaluation as hardware changes.
21 CFR Part 806
Check Your Quality System Against 21 CFR Part 806
An AI-assisted first pass maps your existing documents against the requirements in scope, and an advisor reviews every result. Please don't send confidential documents yet: secure upload is set up after onboarding.
