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U.S. Code of Federal Regulations
Regulations most recently checked for updates: Aug 28, 2025
All Titles
Title 21
Chapter I
Part 801
Subpart D - Subpart D—Exemptions From Adequate Directions for Use
§ 801.109 - Prescription devices.
§ 801.110 - Retail exemption for prescription devices.
§ 801.116 - Medical devices having commonly known directions.
§ 801.119 - In vitro diagnostic products.
§ 801.122 - Medical devices for processing, repacking, or manufacturing.
§ 801.125 - Medical devices for use in teaching, law enforcement, research, and analysis.
§ 801.127 - Medical devices; expiration of exemptions.
§ 801.128 - Exceptions or alternatives to labeling requirements for medical devices held by the Strategic National Stockpile.
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