Subpart A—Assignment of Agency Component for Review of Premarket Applications

Sections

• 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.