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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 880General Hospital and Personal Use Devices880.1 – 880.6992
Subpart AGeneral Provisions880.1 – 880.9
§ 880.1Scope.
§ 880.3Effective dates of requirement for premarket approval.
§ 880.9Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
Subpart B [Reserved]
Subpart CGeneral Hospital and Personal Use Monitoring Devices880.2200 – 880.2930
§ 880.2200Liquid crystal forehead temperature strip.
§ 880.2400Bed-patient monitor.
§ 880.2420Electronic monitor for gravity flow infusion systems.
§ 880.2460Electrically powered spinal fluid pressure monitor.
§ 880.2500Spinal fluid manometer.
§ 880.2700Stand-on patient scale.
§ 880.2720Patient scale.
§ 880.2740Surgical sponge scale.
§ 880.2750Image processing device for estimation of external blood loss.
§ 880.2800Sterilization process indicator.
§ 880.2900Clinical color change thermometer.
§ 880.2910Clinical electronic thermometer.
§ 880.2920Clinical mercury thermometer.
§ 880.2930Apgar timer.
Subparts D-E [Reserved]
Subpart FGeneral Hospital and Personal Use Therapeutic Devices880.5025 – 880.5970
Subpart GGeneral Hospital and Personal Use Miscellaneous Devices880.6025 – 880.6992