21 CFR 820.86
Acceptance status
21 CFR 820.86 is the regulation titled “Acceptance status” in 21 CFR Part 820, Quality System Regulation (before Feb 2, 2026). Since 2021, 7 FDA warning letters have cited it.
Part 820 changed when FDA's Quality Management System Regulation took effect on February 2, 2026. This is the earlier text these letters cite.
- Letters citing it
- 7 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 3 on the same dates in 2025
- Most often cited with
- 21 CFR 820.198, in 6 letters
- Closed out
- 29% of these letters have a published close-out
Letters citing it, by year issued
All are medical device letters. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
What FDA writes when it cites it
The finding headings that cite 21 CFR 820.86 most often, as written in the letters.
- 2 lettersFailure to identify by suitable means the acceptance status of product, to indicate the conformance or nonconformance of product with acceptance criteria, as required by 21 CFR 820.86
The regulation
Read the text of 21 CFR 820.86 (eCFR, as of Jun 1, 2025)
Each manufacturer shall identify by suitable means the acceptance status of product, to indicate the conformance or nonconformance of product with acceptance criteria. The identification of acceptance status shall be maintained throughout manufacturing, packaging, labeling, installation, and servicing of the product to ensure that only product which has passed the required acceptance activities is distributed, used, or installed.
Text from eCFR as of Jun 1, 2025.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 820.86.
- 21 CFR 820.198Complaint files6 letters cite both
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?5 letters cite both
- 21 CFR 820.30Design controls5 letters cite both
- 21 CFR 820.75Process validation4 letters cite both
- 21 CFR 820.100Corrective and preventive action3 letters cite both
- 21 CFR 820.120Device labeling3 letters cite both
- 21 CFR 820.184Device history record3 letters cite both
- 21 CFR 820.70Production and process controls3 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 820.86 that FDA posted most recently.
- DevicesView LEVO AGLEVO C3; LEVO Combi; LEVO LAE; and LEVO LCEV, Class II Standup WheelchairsIssuedJul 18, 2025PostedOct 21, 2025
- DevicesView DFI Co., Ltd.CYBOW 11 Reagent Strips for UrinalysisIssuedMay 6, 2025PostedJun 3, 2025
- DevicesView Exer Labs, Inc.Exer ScanIssuedFeb 10, 2025PostedMar 25, 2025
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Counts include every citation in a letter, as the Letters filter does. How this database is built.