Subpart D—Exemptions From Adequate Directions for Use

1. CFR
2. ›
3. Title 21
4. ›
5. Chapter I
6. ›
7. Part 801
8. ›
9. Subpart D

Sections

Section numbering in the official eCFR can be non-consecutive. Omitted section numbers are not treated here as reserved unless the source explicitly labels them that way.

• 801.109
  § 801.109 Prescription devices.
• 801.110
  § 801.110 Retail exemption for prescription devices.
• 801.116
  § 801.116 Medical devices having commonly known directions.
• 801.119
  § 801.119 In vitro diagnostic products.
• 801.122
  § 801.122 Medical devices for processing, repacking, or manufacturing.
• 801.125
  § 801.125 Medical devices for use in teaching, law enforcement, research, and analysis.
• 801.127
  § 801.127 Medical devices; expiration of exemptions.
• 801.128
  § 801.128 Exceptions or alternatives to labeling requirements for medical devices held by the Strategic National Stockpile.