21 CFR 806.1
Scope
21 CFR 806.1 is the regulation titled “Scope” 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
- 1 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 7.3, 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
- 02024
- 02025
- 12026
What FDA writes when it cites it
The finding headings that cite 21 CFR 806.1 most often, as written in the letters.
- 1 letterFailure to submit to the FDA within 10 working days of initiating a correction or removal a report required by 21 CFR 806.10. For example:
The regulation
Read the text of 21 CFR 806.1 (eCFR, as of Sep 1, 2026)
(a) This part implements the provisions of section 519(g) of the Federal Food, Drug, and Cosmetic Act (the act) requiring device manufacturers and importers to report promptly to the Food and Drug Administration (FDA) certain actions concerning device corrections and removals, and to maintain records of all corrections and removals regardless of whether such corrections and removals are required to be reported to FDA.
(b) The following actions are exempt from the reporting requirements of this part:
(1) Actions taken by device manufacturers or importers to improve the performance or quality of a device but that do not reduce a risk to health posed by the device or remedy a violation of the act caused by the device.
(2) Market withdrawal as defined in § 806.2(i)
(3) Routine servicing as defined in § 806.2(l).
(4) Stock recovery as defined in § 806.2(m).
[62 FR 27191, May 19, 1997, as amended at 63 FR 42232, Aug. 7, 1998; 84 FR 12083, Apr. 1, 2019]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 806.1.
- 21 CFR 7.3Definitions1 letter cites both
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1 letter cites both
- 21 CFR 803.3How does FDA define the terms used in this part?1 letter cites both
- 21 CFR 803.50If I am a manufacturer, what reporting requirements apply to me?1 letter cites both
- 21 CFR 803.52If I am a manufacturer, what information must I submit in my individual adverse event reports?1 letter cites both
- 21 CFR 806.10Reports of corrections and removals1 letter cites both
- 21 CFR 820.100Corrective and preventive action1 letter cites both
- 21 CFR 820.198Complaint files1 letter cites both
Latest letters citing it
The letter citing 21 CFR 806.1 that FDA posted most recently.
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Counts include every citation in a letter, as the Letters filter does. How this database is built.