21 CFR 3.10 - Stay of review time.

Regulations last checked for updates: May 01, 2025

Title 21 - Food and Drugs last revised: Apr 28, 2025

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

§ 3.10 - Stay of review time.

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.

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

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

cite as: 21 CFR 3.10