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Title 21

Displaying title 21, up to date as of 7/08/2026. Title 21 was last amended 7/07/2026.
There have been changes in the last two weeks to Part 888.
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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 888Orthopedic Devices888.1 – 888.5980
Subpart AGeneral Provisions888.1 – 888.9
§ 888.1Scope.
§ 888.3Effective dates of requirement for premarket approval.
§ 888.5Resurfacing technique.
§ 888.6Degree of constraint.
§ 888.9Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
Subpart BDiagnostic Devices888.1100 – 888.1600
§ 888.1100Arthroscope.
§ 888.1240AC-powered dynamometer.
§ 888.1250Nonpowered dynamometer.
§ 888.1500Goniometer.
§ 888.1520Nonpowered goniometer.
§ 888.1600Bone indentation device.
Subpart C [Reserved]
Subpart DProsthetic Devices888.3000 – 888.3810
Subpart ESurgical Devices888.4150 – 888.5980