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Library / 21 CFR / Part 3

21 CFR

Part 3 Product Jurisdiction

10 sections Official text on eCFR

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

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