1. Regulations
  2. title 21
  3. chapter I
  4. part 3
  5. subpart A
  6. § 3.3

View all text of Subpart A [§ 3.1 - § 3.10]

§ 3.3 - Scope.

This section applies to:

(a) Any combination product, or

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

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.

CITE AS: 21 CFR 3.3