21 CFR 820.72
Inspection, measuring, and test equipment
21 CFR 820.72 is the regulation titled “Inspection, measuring, and test equipment” in 21 CFR Part 820, Quality System Regulation (before Feb 2, 2026). Since 2021, 10 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
- 10 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 2 on the same dates in 2025
- Most often cited with
- 21 CFR 820.30, in 9 letters
- Closed out
- 30% 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 820.72 most often, as written in the letters.
- 2 lettersFailure to ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid…
- 1 letterFailure to adequately document equipment inspections, checks and maintenance activities, as required by 21 CFR 820.72(a)
- 1 letterFailure to adequately establish and maintain procedures to ensure equipment is routinely calibrated, inspected, checked, and maintained as required by 21 CFR 820.72(a)
The regulation
Read the text of 21 CFR 820.72 (eCFR, as of Jun 1, 2025)
(a) Control of inspection, measuring, and test equipment. Each manufacturer shall ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results. Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained. The procedures shall include provisions for handling, preservation, and storage of equipment, so that its accuracy and fitness for use are maintained. These activities shall be documented.
(b) Calibration. Calibration procedures shall include specific directions and limits for accuracy and precision. When accuracy and precision limits are not met, there shall be provisions for remedial action to reestablish the limits and to evaluate whether there was any adverse effect on the device's quality. These activities shall be documented.
(1) Calibration standards. Calibration standards used for inspection, measuring, and test equipment shall be traceable to national or international standards. If national or international standards are not practical or available, the manufacturer shall use an independent reproducible standard. If no applicable standard exists, the manufacturer shall establish and maintain an in-house standard.
(2) Calibration records. The equipment identification, calibration dates, the individual performing each calibration, and the next calibration date shall be documented. These records shall be displayed on or near each piece of equipment or shall be readily available to the personnel using such equipment and to the individuals responsible for calibrating the equipment.
Text from eCFR as of Jun 1, 2025.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 820.72.
- 21 CFR 820.30Design controls9 letters cite both
- 21 CFR 820.100Corrective and preventive action7 letters cite both
- 21 CFR 820.50Purchasing controls6 letters cite both
- 21 CFR 820.70Production and process controls6 letters cite both
- 21 CFR 820.75Process validation6 letters cite both
- 21 CFR 807.81When a premarket notification submission is required5 letters cite both
- 21 CFR 820.198Complaint files5 letters cite both
- 21 CFR 820.184Device history record4 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 820.72 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 The Richline Group, Inc.Inverness Ear Care Antiseptic, Inverness Ear Care Solution, Inverness Home Ear Piercing KitIssuedAug 25, 2025PostedSep 23, 2025
- DevicesView Wissner-Bosserhoff GmbHnursing beds including the Sentida SC Nursing Bed and SafeControl handsetIssuedAug 30, 2024PostedSep 3, 2024
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Counts include every citation in a letter, as the Letters filter does. How this database is built.