19. U.S. Agent (cont.)

Overview of Registration and Prior Notice Interim Final Rules

April 2004

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U.S. Agent (cont.)

• Acts as a communications link between FDA and the facility
  • for both routine and emergency communications,
  • unless the facility opts to designate a different emergency contact
• 
  
• Having one U.S. agent for registration purposes does not preclude a foreign facility from having multiple agents for other purposes (E.g., sales)