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Last updated
General regulatory information, not legal or medical advice. Checked 2026-11-01 against the eCFR text of 21 CFR Part 806 and the FDA page on device recalls, corrections and removals.
Short answer
21 CFR Part 806 is the US rule that makes a device manufacturer or importer report to FDA a correction or removal it initiates to reduce a risk to health, within 10 working days of starting it. Actions that are not reportable still need a written record. The duty sits with the firm that initiates the action, not with the lab or clinic that bought the device.
Definition and scope
Part 806 implements section 519(g) of the Federal Food, Drug, and Cosmetic Act. Under 806.1(a) it requires manufacturers and importers to report certain device corrections and removals promptly, and to keep records of all of them whether or not a report is due (eCFR, 21 CFR Part 806).
Four things are exempt from reporting under 806.1(b): actions that improve performance or quality without reducing a risk to health or remedying a violation; market withdrawal; routine servicing; and stock recovery.
What counts as a correction or removal
- Correction (806.2(d)): repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a device without physically removing it from its point of use.
- Removal (806.2(j)): physically removing a device from its point of use to another location for one of those purposes.
- Risk to health (806.2(k)): either a reasonable probability that use or exposure will cause serious adverse health consequences or death, or that it may cause temporary or medically reversible adverse consequences, or an outcome where the probability of serious consequences is remote.
- Manufacturer (806.2(h)) includes a firm that repackages or changes the container or labeling, and one that initiates specifications for a device made by a second party.
The 10-working-day report
Under 806.10(a), a manufacturer or importer must send FDA a written report of a correction or removal it initiated to reduce a risk to health, or to remedy a violation of the act caused by the device that may present a risk to health. Under 806.10(b) the report is due within 10 working days of initiating the action.
The report content in 806.10(c) runs to 13 items. Those most relevant to a buyer are the UDI or the model, catalog or code number with the lot or serial number (806.10(c)(5)), the description of the event and the action (c)(7), any illnesses or injuries (c)(8), the quantity affected (c)(9), all domestic and foreign consignees with dates and quantities (c)(11), and copies of the communications about the action (c)(12). If an item is not immediately available, the report must say why and when it will follow (c)(13). If the action later extends to more lots, an amendment citing the original report number is due within 10 working days of starting the extension (806.10(d)).
No Part 806 report is required if a report of the same action has been submitted under Part 803 (medical device reporting) or Part 1004 (806.10(f)). Reports are available for public disclosure under Part 20, with trade secret and personal information removed first (806.40).
Records when no report is filed
Under 806.20, a firm that initiates a non-reportable correction or removal keeps a record containing the device identification and UDI or lot information, a description of the event and action, a copy of the communications, and a justification for not reporting. That justification must contain conclusions and any follow-ups and be reviewed and evaluated by a designated person. Records are kept for 2 years beyond the expected life of the device, even if the firm stops making or importing it, and transfer to a new manufacturer or importer. FDA may access and copy the records at reasonable times (806.30).
Reportable, recordable or exempt: a decision table
| Situation | Part 806 outcome | Source |
|---|---|---|
| Correction or removal initiated to reduce a risk to health, or to remedy a violation that may present a risk to health | Report to FDA within 10 working days | 806.10(a), (b) |
| Same action already required and submitted under Part 803 or Part 1004 | No separate Part 806 report | 806.10(f) |
| Action initiated without a risk to health | No report; record required | FDA page; 806.20 |
| Performance or quality improvement that reduces no risk to health | Exempt from reporting | 806.1(b)(1) |
| Market withdrawal (minor or no violation, such as normal stock rotation) | Exempt from reporting | 806.1(b)(2); 806.2(i) |
| Routine servicing, such as calibration or battery replacement | Exempt from reporting | 806.1(b)(3); 806.2(l) |
| Stock recovery of devices that never left the manufacturer’s control | Exempt from reporting | 806.1(b)(4); 806.2(m) |
Routine servicing has limits: 806.2(l) states that repairs of an unexpected nature, replacement of parts earlier than normal life expectancy, and identical repairs or replacements of multiple units are not routine servicing.
21 CFR 806 vs recall classification vs MDR
| Rule | What it covers | Who acts | Source |
|---|---|---|---|
| 21 CFR Part 806 | Reports of corrections and removals; records of unreported ones | Manufacturer or importer that initiates the action | eCFR |
| 21 CFR Part 7 (recalls) | Voluntary recalls; FDA assigns Class I, II or III | Recalling firm; FDA classifies | FDA page |
| 21 CFR Part 810 | Procedures for FDA’s mandatory device recall authority under section 518(e) | FDA | FDA page |
| 21 CFR Part 803 | Medical device reporting; a report there can satisfy 806.10(f) | Reporting entity under Part 803 | eCFR |
FDA states that the definition of risk to health in Part 806 tracks the Class I and Class II recall definitions in 21 CFR 7.3(m), so corrections and removals are reportable for Class I and Class II situations, while a firm that has no risk-to-health action must still keep a record. FDA also notes that when no Part 806 report is required, the firm may report voluntarily under Part 7 (FDA, Recalls, Corrections and Removals (Devices)). For the recall side, see the guide to medical device recalls.
Where it matters for labs, clinics and supply decisions
Because the rule puts the report and the record on the initiating manufacturer or importer, a purchaser’s practical interest is in what the supplier can show after an action. These are questions to ask, framed from the rule’s own content requirements:
- Does the supplier’s notice identify the device by UDI or model, catalog or code number and by lot or serial number, as 806.10(c)(5) and 806.20(b)(2) require the firm’s own file to do?
- Does the notice describe the event and the action being taken, as in 806.10(c)(7)?
- Was the action reported to FDA, or does the supplier hold a 806.20 record with a justification for not reporting?
- Is the purchaser on the consignee list the firm must compile (806.10(c)(11))?
These checks pair with a supplier’s quality system (21 CFR Part 820, CAPA under FDA rules), its handling of field safety corrective actions, and your own vendor documentation checklist. FDA publishes recall information in its enforcement reports.
Common misunderstandings
“Every correction or removal is a recall.”
Not under the FDA’s framing. Part 806 can apply to a correction or removal that is not a Part 7 recall, and exempt categories such as market withdrawal sit outside the reporting duty.
“The distributor or the hospital files the report.”
806.10(a) assigns the report to the manufacturer or importer that initiated the action.
“No report means no paperwork.”
806.20 requires a record, including a reviewed written justification for not reporting.
“The 10 days run from when the problem was found.”
806.10(b) counts 10 working days from initiating the correction or removal.
FAQ
What is 21 CFR Part 806?
It is the FDA regulation, titled Medical Devices; Reports of Corrections and Removals, that requires manufacturers and importers to report certain device corrections and removals and to keep records of all of them.
Does 21 CFR 806 medical device recall reporting apply to every recall?
It applies to corrections and removals initiated to reduce a risk to health or to remedy a violation that may present one, unless an exemption in 806.1(b) or the Part 803 and 1004 carve-out in 806.10(f) applies.
Who must file a Part 806 report?
The manufacturer or importer that initiated the correction or removal (806.10(a)). FDA states that only the person that initiates the action is required to report.
What is the Part 806 reporting deadline?
10 working days from initiating the correction or removal (806.10(b)).
How long are Part 806 records kept?
For corrections and removals that were not reported, 2 years beyond the expected life of the device (806.20(c)).
Are Part 806 reports public?
They are available for public disclosure under Part 20, after FDA deletes trade secret and personal information (806.40).
Sources
- eCFR, 21 CFR Part 806, Medical Devices; Reports of Corrections and Removals (https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-806), date checked 2026-11-01.
- FDA, Recalls, Corrections and Removals (Devices) (https://www.fda.gov/medical-devices/postmarket-requirements-devices/recalls-corrections-and-removals-devices), date checked 2026-11-01.
