Title 21

PART 812 SUBPART B

Subpart B - Application and Administrative Action

• 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.

21:8.0.1.1.9.2.1.1	SECTION 812.20	812.20 Application.
21:8.0.1.1.9.2.1.2	SECTION 812.25	812.25 Investigational plan.
21:8.0.1.1.9.2.1.3	SECTION 812.27	812.27 Report of prior investigations.
21:8.0.1.1.9.2.1.4	SECTION 812.28	812.28 Acceptance of data from clinical investigations conducted outside the United States.
21:8.0.1.1.9.2.1.5	SECTION 812.30	812.30 FDA action on applications.
21:8.0.1.1.9.2.1.6	SECTION 812.35	812.35 Supplemental applications.
21:8.0.1.1.9.2.1.7	SECTION 812.36	812.36 Treatment use of an investigational device.
21:8.0.1.1.9.2.1.8	SECTION 812.38	812.38 Confidentiality of data and information.

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