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Title 21

Displaying title 21, up to date as of 7/09/2026. 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 874Ear, Nose, and Throat Devices874.1 – 874.6000
Subpart AGeneral Provisions874.1 – 874.9
§ 874.1Scope.
§ 874.3Effective dates of requirement for premarket approval.
§ 874.9Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
Subpart BDiagnostic Devices874.1050 – 874.1925
Subpart C [Reserved]
Subpart DProsthetic Devices874.3300 – 874.3950
Subpart ESurgical Devices874.4100 – 874.4800
Subpart FTherapeutic Devices874.5220 – 874.6000
§ 874.5220Ear, nose, and throat drug administration device.
§ 874.5300Ear, nose, and throat examination and treatment unit.
§ 874.5350Suction antichoke device.
§ 874.5370Tongs antichoke device.
§ 874.5550Powered nasal irrigator.
§ 874.5800External nasal splint.
§ 874.5840Antistammering device.
§ 874.5900External upper esophageal sphincter compression device.
§ 874.5950Oropharyngeal electrical stimulator.
§ 874.6000Transcutaneous electrical nerve stimulator for the relief of congestion.