21 CFR Part 3 · Product Jurisdiction

§ 3.10 Stay of review time

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

Any filing with or review by the product jurisdiction officer stays the review clock or other established time periods for agency action for an application for marketing approval or required investigational notice during the pendency of the review by the product jurisdiction officer.

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.

FDA guidance that cites § 3.10

How to Write a Request for Designation (RFD): Guidance for Industry 14 Apr 2011

Amendment history

Federal Register documents that created or amended this section.

56 FR 58756 21 Nov 1991
78 FR 4321 22 Jan 2013
90 FR 51765 18 Jun 2024