21 CFR 820.25
Personnel
21 CFR 820.25 is the regulation titled “Personnel” in 21 CFR Part 820, Quality System Regulation (before Feb 2, 2026). Since 2021, 18 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
- 18 since 2021
- Jan 1 to Oct 30, 2026
- 2 against 8 on the same dates in 2025
- Most often cited with
- 21 CFR 820.198, in 14 letters
- Closed out
- 28% 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 820.25 most often, as written in the letters.
- 1 letterFailure to adequately ensure that all personnel are trained to adequately perform their assigned responsibilities, and document training, as required by 21 CFR 820.25(b). Specifically,
- 1 letterFailure to adequately establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b)
- 1 letterFailure to adequately establish procedures for identifying training needs and ensuring that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b). For example,…
The regulation
Read the text of 21 CFR 820.25 (eCFR, as of Jun 1, 2025)
(a) General. Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed.
(b) Training. Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented.
(1) As part of their training, personnel shall be made aware of device defects which may occur from the improper performance of their specific jobs.
(2) Personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job functions.
Text from eCFR as of Jun 1, 2025.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 820.25.
- 21 CFR 820.198Complaint files14 letters cite both
- 21 CFR 820.100Corrective and preventive action13 letters cite both
- 21 CFR 820.30Design controls11 letters cite both
- 21 CFR 807.81When a premarket notification submission is required10 letters cite both
- 21 CFR 820.50Purchasing controls10 letters cite both
- 21 CFR 820.22Quality audit9 letters cite both
- 21 CFR 820.70Production and process controls9 letters cite both
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?8 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 820.25 that FDA posted most recently.
- DevicesView BlephEx, LLCBlephEx Powered Eyelid Cleaning Sponge, OptiVize Ophthalmic Battery-Powered Electrolysis Unit, OptiVize Ophthalmic ForcepsIssuedJun 3, 2026PostedJul 7, 2026
- DevicesView 3B Medical, Inc. dba Reach Health, Inc.Cloud-based software and APAP/BPAP ventilator devices for obstructive sleep apneaIssuedMay 20, 2026PostedJun 30, 2026
- DevicesView Exactech, Inc. dba Advita OrthoEquinoxe Reverse Shoulder Compression Screw and accessoriesIssuedDec 19, 2025PostedMar 10, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.