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Title 21

Displaying title 21, up to date as of 9/22/2021. Title 21 was last amended 9/21/2021.
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Title 21 Food and Drugs Part / Section
Chapter I Food and Drug Administration, Department of Health and Human Services 1 – 1299
Subchapter H Medical Devices 800 – 898
Part 801 Labeling 801.1 – 801.437
Subpart A General Labeling Provisions 801.1 – 801.18
§ 801.1 Medical devices; name and place of business of manufacturer, packer or distributor.
§ 801.3 Definitions.
§ 801.4 Meaning of intended uses.
§ 801.5 Medical devices; adequate directions for use.
§ 801.6 Medical devices; misleading statements.
§ 801.15 Medical devices; prominence of required label statements; use of symbols in labeling.
§ 801.16 Medical devices; Spanish-language version of certain required statements.
§ 801.18 Format of dates provided on a medical device label.
Subpart B Labeling Requirements for Unique Device Identification 801.20 – 801.57
Subpart C Labeling Requirements for Over-the-Counter Devices 801.60 – 801.63
§ 801.60 Principal display panel.
§ 801.61 Statement of identity.
§ 801.62 Declaration of net quantity of contents.
§ 801.63 Medical devices; warning statements for devices containing or manufactured with chlorofluorocarbons and other class I ozone-depleting substances.
Subpart D Exemptions From Adequate Directions for Use 801.109 – 801.128
Subpart E Other Exemptions 801.150
§ 801.150 Medical devices; processing, labeling, or repacking.
Subparts F-G [Reserved]
Subpart H Special Requirements for Specific Devices 801.405 – 801.437