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U.S. Code of Federal Regulations
Regulations most recently checked for updates: Aug 27, 2025
All Titles
Title 21
Chapter I
Part 801
Subpart A - Subpart A—General Labeling Provisions
§ 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.
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