Assignment of Agency Component for Review of Premarket Applications

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. General
  6. Product Jurisdiction
  7. Assignment of Agency Component for Review of Premarket Applications

Checkout our iOS App for a better way to browser and research.

Section
3.1

Purpose.

Section
3.2

Definitions.

Section
3.3

Scope.

Section
3.4

Designated agency component.

Section
3.5

Procedures for identifying the designated agency component.

Section
3.6

Product jurisdiction officer.

Section
3.7

Request for designation.

Section
3.8

Letter of designation.

Section
3.9

Effect of letter of designation.

Section
3.10

Stay of review time.