21 CFR § 3.3 - Scope.

---
identifier: "/us/cfr/t21/s3.3"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 3.3 - Scope."
title_number: 21
title_name: "Food and Drugs"
section_number: "3.3"
section_name: "Scope."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "A"
subchapter_name: "GENERAL"
part_number: "3"
part_name: "PRODUCT JURISDICTION"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
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."
regulatory_source: "56 FR 58756, Nov. 21, 1991, unless otherwise noted."
cfr_part: "3"
---


# 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.