FDA-regulated testing labs: GLP and cGMP

21 CFR Part 58 (GLP) governs nonclinical laboratory studies supporting FDA applications. cGMP regulations (e.g. 21 CFR 211 for drugs, Part 820 for devices) govern labs testing regulated products for release.

No FDA lab license

FDA does not issue a general lab license; compliance is assessed through inspections and submissions.

General guidance, not legal advice. Requirements depend on industry, jurisdiction and test purpose; confirm with the relevant agency.