§3.3. Scope.

21 C.F.R. § 3.3

This section applies to:

(a)

Any combination product, or

(b)

Any product where the agency component with primary jurisdiction is unclear or in dispute.

Notes, amendments, and revision history

Authority: 21 U.S.C. 321, 351, 353, 355, 360, 360c-360f, 360h-360j, 360gg-360ss, 360bbb-2, 371(a), 379e, 381, 394; 42 U.S.C. 216, 262, 264.

Source: 56 FR 58756, Nov. 21, 1991, unless otherwise noted.