21 CFR Part 801 - 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.