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  1. Regulations
    All Titles
  2. title 21
    Food and Drugs
  3. chapter I-i7
    CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
  4. part 801
    PART 801—LABELING
  5. subpart D
    Subpart D—Exemptions From Adequate Directions for Use

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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