21 CFR 820.250
Statistical techniques
21 CFR 820.250 is the regulation titled “Statistical techniques” in 21 CFR Part 820, Quality System Regulation (before Feb 2, 2026). Since 2021, 6 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
- 6 since 2021
- Jan 1 to Oct 30, 2026
- 1 against 3 on the same dates in 2025
- Most often cited with
- 21 CFR 820.100, in 5 letters
- Closed out
- 0% 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 820.250 most often, as written in the letters.
- 1 letterFailure to adequately establish and maintain procedures to ensure that sampling methods are adequate for their intended use and to ensure that when changes occur the sampling plans are reviewed, as required by 21 CFR…
- 1 letterFailure to adequately establish and maintain procedures, where appropriate, for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and…
- 1 letterFailure to establish and maintain procedures for identifying valid statistical techniques and to ensure that sampling plans are adequate for their intended use, as required by 21 CFR 820.250
The regulation
Read the text of 21 CFR 820.250 (eCFR, as of Jun 1, 2025)
(a) Where appropriate, each manufacturer shall establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics.
(b) Sampling plans, when used, shall be written and based on a valid statistical rationale. Each manufacturer shall establish and maintain procedures to ensure that sampling methods are adequate for their intended use and to ensure that when changes occur the sampling plans are reviewed. These activities shall be documented.
Text from eCFR as of Jun 1, 2025.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 820.250.
- 21 CFR 820.100Corrective and preventive action5 letters cite both
- 21 CFR 820.30Design controls5 letters cite both
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?3 letters cite both
- 21 CFR 820.50Purchasing controls3 letters cite both
- 21 CFR 820.80Receiving, in-process, and finished device acceptance3 letters cite both
- 21 CFR 803.12How do I submit initial and supplemental or followup reports?2 letters cite both
- 21 CFR 803.3How does FDA define the terms used in this part?2 letters cite both
- 21 CFR 803.50If I am a manufacturer, what reporting requirements apply to me?2 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 820.250 that FDA posted most recently.
- DevicesView Abbott Diabetes Care, Inc.FreeStyle Libre Flash and Continuous Glucose Monitoring Systems including the FreeStyle Libre 3IssuedJan 23, 2026PostedFeb 3, 2026
- DevicesView Meridian Bioscience, Incin-vitro diagnostic (IVD) kits that measure blood lead levels, including LeadCare II Blood Lead Analyzer and Test KitIssuedDec 22, 2025PostedJan 27, 2026
- DevicesView LEVO AGLEVO C3; LEVO Combi; LEVO LAE; and LEVO LCEV, Class II Standup WheelchairsIssuedJul 18, 2025PostedOct 21, 2025
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Counts include every citation in a letter, as the Letters filter does. How this database is built.