Title 21

PART 812 SUBPART A

Subpart A - General Provisions

• 21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f, 360h-360j, 360bbb-8b, 371, 372, 374, 379e, 379k-1, 381, 382, 383; 42 U.S.C. 216, 241, 262, 263b-263n.
• 45 FR 3751, Jan. 18, 1980, unless otherwise noted.

21:8.0.1.1.9.1.1.1	SECTION 812.1	812.1 Scope.
21:8.0.1.1.9.1.1.2	SECTION 812.2	812.2 Applicability.
21:8.0.1.1.9.1.1.3	SECTION 812.3	812.3 Definitions.
21:8.0.1.1.9.1.1.4	SECTION 812.5	812.5 Labeling of investigational devices.
21:8.0.1.1.9.1.1.5	SECTION 812.7	812.7 Prohibition of promotion and other practices.
21:8.0.1.1.9.1.1.6	SECTION 812.10	812.10 Waivers.
21:8.0.1.1.9.1.1.7	SECTION 812.18	812.18 Import and export requirements.
21:8.0.1.1.9.1.1.8	SECTION 812.19	812.19 Address for IDE correspondence.

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