Subpart A—Assignment of Agency Component for Review of Premarket Applications
Sections
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3.1
§ 3.1 Purpose. -
3.2
§ 3.2 Definitions. -
3.3
§ 3.3 Scope. -
3.4
§ 3.4 Designated agency component. -
3.5
§ 3.5 Procedures for identifying the designated agency component. -
3.6
§ 3.6 Product jurisdiction officer. -
3.7
§ 3.7 Request for designation. -
3.8
§ 3.8 Letter of designation. -
3.9
§ 3.9 Effect of letter of designation. -
3.10
§ 3.10 Stay of review time.