To designate a U.S. agent for FDA registration, follow these steps:

1. Understand the Requirement:

   • Foreign manufacturers of medical devices must designate a U.S. agent. The U.S. agent acts as a liaison between the FDA and the manufacturer, handling communications and regulatory matters.

2. Select a U.S. Agent:

   • Choose a U.S. agent who meets the FDA’s requirements. The agent must be located in the United States and be available during normal business hours to handle regulatory communications.

3. Draft an Agreement:

   • Prepare a written agreement outlining the responsibilities and duties of the U.S. agent. This should include handling FDA correspondence, regulatory submissions, and compliance issues.

4. Submit Designation to the FDA:

   • Include the U.S. agent’s details in your FDA registration. When filling out the FDA Establishment Registration and Device Listing forms (FDA Form 2891 and FDA Form 2892), provide the U.S. agent’s name, address, and contact information.

5. Update Registration:

   • If there are any changes to the U.S. agent or if a new agent is appointed, update the FDA registration promptly by submitting a new Form 2891. This ensures that the FDA has current contact information.

6. Maintain Communication:

   • Ensure regular communication with your U.S. agent to stay updated on any regulatory changes or requirements. The agent will be responsible for managing FDA interactions on your behalf.

By following these steps, you ensure compliance with FDA requirements and maintain effective communication channels for your medical device’s registration and regulatory matters in the United States.

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