21 CFR 58.130
Conduct of a nonclinical laboratory study
21 CFR 58.130 is the regulation titled “Conduct of a nonclinical laboratory study” in 21 CFR Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies. Since 2021, 3 FDA warning letters have cited it.
- Letters citing it
- 3 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 1 on the same dates in 2025
- Most often cited with
- 21 CFR 58.33, in 3 letters
- Closed out
- 33% of these letters have a published close-out
Letters citing it, by year issued
Most are medical device letters (2 of 3). 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 58.130 most often, as written in the letters.
- 2 lettersFailure to conduct nonclinical laboratory studies in accordance with the protocols [21 CFR 58.130(a)]
- 1 letterFailure to properly identify specimens used in nonclinical laboratory studies by test system, study, nature, and date of collection [21 CFR 58.130(c)]
The regulation
Read the text of 21 CFR 58.130 (eCFR, as of Sep 1, 2026)
(a) The nonclinical laboratory study shall be conducted in accordance with the protocol.
(b) The test systems shall be monitored in conformity with the protocol.
(c) Specimens shall be identified by test system, study, nature, and date of collection. This information shall be located on the specimen container or shall accompany the specimen in a manner that precludes error in the recording and storage of data.
(d) Records of gross findings for a specimen from postmortem observations should be available to a pathologist when examining that specimen histopathologically.
(e) All data generated during the conduct of a nonclinical laboratory study, except those that are generated by automated data collection systems, shall be recorded directly, promptly, and legibly in ink. All data entries shall be dated on the date of entry and signed or initialed by the person entering the data. Any change in entries shall be made so as not to obscure the original entry, shall indicate the reason for such change, and shall be dated and signed or identified at the time of the change. In automated data collection systems, the individual responsible for direct data input shall be identified at the time of data input. Any change in automated data entries shall be made so as not to obscure the original entry, shall indicate the reason for change, shall be dated, and the responsible individual shall be identified.
[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33781, Sept. 4, 1987; 67 FR 9585, Mar. 4, 2002]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 58.130.
- 21 CFR 58.33Study director3 letters cite both
- 21 CFR 58.35Quality assurance unit3 letters cite both
- 21 CFR 58.185Reporting of nonclinical laboratory study results2 letters cite both
- 21 CFR 58.190Storage and retrieval of records and data2 letters cite both
- 21 CFR 58.202Grounds for disqualification2 letters cite both
- 21 CFR 58.90Animal care2 letters cite both
- 21 CFR 58.120Protocol1 letter cites both
- 21 CFR 58.29Personnel1 letter cites both
Latest letters citing it
The 3 letters citing 21 CFR 58.130 that FDA posted most recently.
- DevicesView CCIC Huatongwei International Inspection Co., Ltd.GLP nonclinical safety testing for medical devicesIssuedJun 25, 2025PostedAug 26, 2025
- DevicesView Mid-Link Testing Company, Ltdnonclinical laboratory studies for medical devicesIssuedSep 10, 2024PostedSep 11, 2024
- BiologicsView Valley BiosystemsNonclinical GLP studies for investigational productsIssuedAug 3, 2022PostedAug 9, 2022
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Counts include every citation in a letter, as the Letters filter does. How this database is built.