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Title 21

Displaying title 21, up to date as of 7/10/2026. Title 21 was last amended 7/09/2026.
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Title 21Food and DrugsPart / Section
Chapter IFood and Drug Administration, Department of Health and Human Services1 – 1299
Subchapter HMedical Devices800 – 898
Part 862Clinical Chemistry and Clinical Toxicology Devices862.1 – 862.3970
Subpart AGeneral Provisions862.1 – 862.9
§ 862.1Scope.
§ 862.2Regulation of calibrators.
§ 862.3Effective dates of requirement for premarket approval.
§ 862.9Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
Subpart BClinical Chemistry Test Systems862.1020 – 862.1840
Subpart CClinical Laboratory Instruments862.2050 – 862.2920
Subpart DClinical Toxicology Test Systems862.3030 – 862.3970