Exemptions From Adequate Directions for Use

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Medical Devices
  6. Labeling
  7. Exemptions From Adequate Directions for Use

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Section
801.109

Prescription devices.

Section
801.110

Retail exemption for prescription devices.

Section
801.116

Medical devices having commonly known directions.

Section
801.119

In vitro diagnostic products.

Section
801.122

Medical devices for processing, repacking, or manufacturing.

Section
801.125

Medical devices for use in teaching, law enforcement, research, and analysis.

Section
801.127

Medical devices; expiration of exemptions.

Section
801.128

Exceptions or alternatives to labeling requirements for medical devices held by the Strategic National Stockpile.