Title 21

PART 801 SUBPART D

Subpart D - Exemptions From Adequate Directions for Use

• 21 U.S.C. 321, 331, 351, 352, 360d, 360i, 360j, 371, 374.
• 41 FR 6896, Feb. 13, 1976, unless otherwise noted.

21:8.0.1.1.2.4.1.1	SECTION 801.109	801.109 Prescription devices.
21:8.0.1.1.2.4.1.2	SECTION 801.110	801.110 Retail exemption for prescription devices.
21:8.0.1.1.2.4.1.3	SECTION 801.116	801.116 Medical devices having commonly known directions.
21:8.0.1.1.2.4.1.4	SECTION 801.119	801.119 In vitro diagnostic products.
21:8.0.1.1.2.4.1.5	SECTION 801.122	801.122 Medical devices for processing, repacking, or manufacturing.
21:8.0.1.1.2.4.1.6	SECTION 801.125	801.125 Medical devices for use in teaching, law enforcement, research, and analysis.
21:8.0.1.1.2.4.1.7	SECTION 801.127	801.127 Medical devices; expiration of exemptions.
21:8.0.1.1.2.4.1.8	SECTION 801.128	801.128 Exceptions or alternatives to labeling requirements for medical devices held by the Strategic National Stockpile.

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