C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER A—GENERAL › PART 3—PRODUCT JURISDICTION › Subpart A—Assignment of Agency Component for Review of Premarket Applications

21 C.F.R. § 3.10

Stay of review time

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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.