eCFR Reference Browser

---

title: "21 CFR §3.10"

source: "https://www.ecfr.gov/current/title-21/section-3.10"

title_number: "21"

volume_number: "1"

chapter_number: "Unknown"

subchapter_code: "A"

subchapter_subject: "GENERAL"

part_code: "3"

part_subject: "PRODUCT JURISDICTION"

subpart_code: "A"

subpart_subject: "Assignment of Agency Component for Review of Premarket Applications"

section_number: "3.10"

section_subject: "Stay of review time."

cfr_reference: "21 CFR 3.10"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 1 to 99"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

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.

§3.10 - Stay of review time.