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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.
There have been changes in the last two weeks to Part 878.
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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 878General and Plastic Surgery Devices878.1 – 878.5910
Subpart AGeneral Provisions878.1 – 878.9
§ 878.1Scope.
§ 878.3Effective dates of requirement for premarket approval.
§ 878.9Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
Subpart BDiagnostic Devices878.1800 – 878.1820
§ 878.1800Speculum and accessories.
§ 878.1820Software-aided adjunctive diagnostic device for use on skin lesions by physicians trained in the diagnosis and management of skin cancer.
Subpart C [Reserved]
Subpart DProsthetic Devices878.3250 – 878.3925
Subpart ESurgical Devices878.4010 – 878.5050
Subpart FTherapeutic Devices878.5070 – 878.5910
§ 878.5070Air-handling apparatus for a surgical operating room.
§ 878.5080Air-handling apparatus accessory.
§ 878.5350Needle-type epilator.
§ 878.5360Tweezer-type epilator.
§ 878.5400Low level laser system for aesthetic use
§ 878.5650Topical oxygen chamber for extremities.
§ 878.5900Nonpneumatic tourniquet.
§ 878.5910Pneumatic tourniquet.