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Regulations last checked for updates: May 23, 2025

Title 21 - Food and Drugs last revised: May 19, 2025
All TitlesTitle 21Chapter IPart 3Subpart A - Subpart A—Assignment of Agency Component for Review of Premarket Applications
  • § 3.1 - Purpose.
  • § 3.2 - Definitions.
  • § 3.3 - Scope.
  • § 3.4 - Designated agency component.
  • § 3.5 - Procedures for identifying the designated agency component.
  • § 3.6 - Product jurisdiction officer.
  • § 3.7 - Request for designation.
  • § 3.8 - Letter of designation.
  • § 3.9 - Effect of letter of designation.
  • § 3.10 - Stay of review time.
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.
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