21 CFR Subpart A
Assignment of Agency Component for Review of Premarket Applications
June 25, 2020
§
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
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