Title 21

PART 812 SUBPART D

Subpart D - IRB Review and Approval

• 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.

21:8.0.1.1.9.4.1.1	SECTION 812.60	812.60 IRB composition, duties, and functions.
21:8.0.1.1.9.4.1.2	SECTION 812.62	812.62 IRB approval.
21:8.0.1.1.9.4.1.3	SECTION 812.64	812.64 IRB's continuing review.
21:8.0.1.1.9.4.1.4	SECTION 812.65	812.65 [Reserved]
21:8.0.1.1.9.4.1.5	SECTION 812.66	812.66 Significant risk device determinations.

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