A U.S. agent is a representative designated by a foreign manufacturer of medical devices to act as their liaison with the FDA. Here’s an overview of their role and duties:

Role of a U.S. Agent:

1. Regulatory Liaison:

   • Acts as the primary contact between the FDA and the foreign manufacturer. They facilitate communication and manage regulatory matters on behalf of the manufacturer.

2. Compliance Facilitator:

   • Ensures that the foreign manufacturer complies with FDA regulations and guidelines. This includes managing and responding to FDA inquiries, inspections, and compliance issues.

Duties of a U.S. Agent:

1. Handling Communications:

   • Receives and responds to communications from the FDA, including questions, notices, and requests for information. The U.S. agent must be available during business hours to manage these communications.

2. Submission Management:

   • Assists in preparing and submitting required documentation to the FDA, such as establishment registration and device listing forms. Ensures that all submissions are complete and accurate.

3. Reporting:

   • Manages the reporting of adverse events and other significant issues related to the medical device. They ensure that all necessary reports are filed with the FDA in a timely manner.

4. Regulatory Guidance:

   • Provides guidance on FDA requirements and helps the manufacturer understand and comply with U.S. regulations. This includes advising on regulatory changes and procedural updates.

5. Record-Keeping:

   • Maintains records of all communications and submissions related to FDA interactions. Ensures that documentation is organized and accessible for review.

In summary, the U.S. agent plays a critical role in ensuring smooth communication between the FDA and the foreign manufacturer, facilitating regulatory compliance, and managing the documentation and reporting processes required for medical device registration and maintenance in the U.S.

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