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21 CFR Part 3 · Product Jurisdiction

§ 3.3 Scope

Subpart A - Assignment of Agency Component for Review of Premarket Applications Official text on eCFR Amendment history

This section applies to:

(a) Any combination product, or

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

Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.

Amendment history

Federal Register documents that created or amended this section.