21 CFR 111.320
§ 111.320 What requirements apply to laboratory methods for testing and examination?
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 111.320, § 111.320 What requirements apply to laboratory methods for testing and examination?, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/84185
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Full text
(a) You must verify that the laboratory examination and testing methodologies are appropriate for their intended use.
(b) You must identify and use an appropriate scientifically valid method for each established specification for which testing or examination is required to determine whether the specification is met.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.