21 CFR § 3.10 - Stay of review time.

---
identifier: "/us/cfr/t21/s3.10"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 3.10 - Stay of review time."
title_number: 21
title_name: "Food and Drugs"
section_number: "3.10"
section_name: "Stay of review time."
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"
---


# 3.10 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.