21 CFR Part 3
PART 3—PRODUCT JURISDICTION
- PART 3—PRODUCT JURISDICTION
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter A—General
- 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.
- Subpart B [Reserved]
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