21 CFR 806.20
Records of corrections and removals not required to be reported
21 CFR 806.20 is the regulation titled “Records of corrections and removals not required to be reported” in 21 CFR Part 806, Medical Devices; Reports of Corrections and Removals. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 820.100, in 1 letter
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
It is a medical device letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 02022
- 02023
- 12024
- 02025
- 02026
What FDA writes when it cites it
The finding headings that cite 21 CFR 806.20 most often, as written in the letters.
- 1 letterFailure to keep a record of a correction or removal that contains information including a justification for not reporting the correction or removal action to FDA which shall contain conclusions and any follow-ups, and…
The regulation
Read the text of 21 CFR 806.20 (eCFR, as of Sep 1, 2026)
(a) Each device manufacturer or importer who initiates a correction or removal of a device that is not required to be reported to FDA under § 806.10 shall keep a record of such correction or removal.
(b) Records of corrections and removals not required to be reported to FDA under § 806.10 shall contain the following information:
(1) The brand name, common or usual name, classification, name and product code if known, and the intended use of the device.
(2) The unique device identifier (UDI) of the device, or the device identifier, universal product code (UPC), model, catalog, or code number of the device and the manufacturing lot or serial number of the device or other identification number.
(3) A description of the event(s) giving rise to the information reported and the corrective or removal action that has been, and is expected to be taken.
(4) Justification for not reporting the correction or removal action to FDA, which shall contain conclusions and any followups, and be reviewed and evaluated by a designated person.
(5) A copy of all communications regarding the correction or removal.
(c) The manufacturer or importer shall retain records required under this section for a period of 2 years beyond the expected life of the device, even if the manufacturer or importer has ceased to manufacture or import the device. Records required to be maintained under paragraph (b) of this section must be transferred to the new manufacturer or importer of the device and maintained for the required period of time.
[62 FR 27191, May 19, 1997, as amended at 63 FR 42233, Aug. 7, 1998; 78 FR 58821, Sept. 24, 2013]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 806.20.
- 21 CFR 820.100Corrective and preventive action1 letter cites both
- 21 CFR 820.184Device history record1 letter cites both
- 21 CFR 820.30Design controls1 letter cites both
- 21 CFR 820.40Document controls1 letter cites both
- 21 CFR 820.50Purchasing controls1 letter cites both
- 21 CFR 820.72Inspection, measuring, and test equipment1 letter cites both
- 21 CFR 820.80Receiving, in-process, and finished device acceptance1 letter cites both
Latest letters citing it
The letter citing 21 CFR 806.20 that FDA posted most recently.
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