Code of Federal Regulations (Last Updated: October 10, 2024) |
Title 21 - Food and Drugs |
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 |
§ 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. |