21 CFR 820.80
Receiving, in-process, and finished device acceptance
21 CFR 820.80 is the regulation titled “Receiving, in-process, and finished device acceptance” in 21 CFR Part 820, Quality System Regulation (before Feb 2, 2026). Since 2021, 40 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
- 40 since 2021
- Jan 1 to Oct 30, 2026
- 4 against 10 on the same dates in 2025
- Most often cited with
- 21 CFR 820.30, in 29 letters
- Closed out
- 20% of these letters have a published close-out
Letters citing it, by year issued
Most are medical device letters (39 of 40). 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 820.80 most often, as written in the letters.
- 2 lettersFailure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR 820.80(d)
- 1 letterFailure to adequately document and maintain acceptance activities as part of the device history record, as required by 21 CFR 820.80(e)
- 1 letterFailure to adequately ensure that the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated with a high degree of assurance and approved according to…
The regulation
Read the text of 21 CFR 820.80 (eCFR, as of Jun 1, 2025)
(a) General. Each manufacturer shall establish and maintain procedures for acceptance activities. Acceptance activities include inspections, tests, or other verification activities.
(b) Receiving acceptance activities. Each manufacturer shall establish and maintain procedures for acceptance of incoming product. Incoming product shall be inspected, tested, or otherwise verified as conforming to specified requirements. Acceptance or rejection shall be documented.
(c) In-process acceptance activities. Each manufacturer shall establish and maintain acceptance procedures, where appropriate, to ensure that specified requirements for in-process product are met. Such procedures shall ensure that in-process product is controlled until the required inspection and tests or other verification activities have been completed, or necessary approvals are received, and are documented.
(d) Final acceptance activities. Each manufacturer shall establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria. Finished devices shall be held in quarantine or otherwise adequately controlled until released. Finished devices shall not be released for distribution until:
(1) The activities required in the DMR are completed;
(2) the associated data and documentation is reviewed;
(3) the release is authorized by the signature of a designated individual(s); and
(4) the authorization is dated.
(e) Acceptance records. Each manufacturer shall document acceptance activities required by this part. These records shall include:
(1) The acceptance activities performed;
(2) the dates acceptance activities are performed;
(3) the results;
(4) the signature of the individual(s) conducting the acceptance activities; and
(5) where appropriate the equipment used. These records shall be part of the DHR.
Text from eCFR as of Jun 1, 2025.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 820.80.
- 21 CFR 820.30Design controls29 letters cite both
- 21 CFR 820.100Corrective and preventive action25 letters cite both
- 21 CFR 820.198Complaint files21 letters cite both
- 21 CFR 820.50Purchasing controls20 letters cite both
- 21 CFR 820.75Process validation18 letters cite both
- 21 CFR 820.90Nonconforming product17 letters cite both
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?16 letters cite both
- 21 CFR 807.81When a premarket notification submission is required15 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 820.80 that FDA posted most recently.
- DevicesView Peter Schiff Enterprisescardiac electrode pads and AC cardiac fibrillatorsIssuedAug 26, 2026PostedOct 27, 2026
- DevicesView Olympus Medical Systems CorporationSurgical and endotherapy devices including clips, sphincterotomes, cystoscopes, bronchoscopes, and insufflators.IssuedOct 7, 2026PostedOct 20, 2026
- DevicesView Physitemp Instruments, LLCClinical Electronic Thermometers (TH-5; TH-5/AOP; TH-8; TH-8/AOP), Clinical Temperature Monitoring Probes (OT-1; ESO-1; RET-1; SST-1;…IssuedNov 12, 2025PostedMar 31, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.