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The responsibilities and obligations of a U.S. Authorized Representative include:

1. Regulatory Liaison: Acting as the primary point of contact between the FDA and the foreign manufacturer. This involves facilitating communication and addressing any inquiries or issues from the FDA.

2. Compliance Assurance: Ensuring that the manufacturer’s products comply with FDA regulations. This includes assisting with the preparation and submission of necessary documentation and reports.

3. Handling Submissions: Managing the submission of regulatory documents, such as 510(k) premarket notifications, PMA applications, or product labeling information to the FDA.

4. Record Maintenance: Keeping accurate records of all interactions and submissions related to the FDA, including correspondence and documentation.

5. Managing Adverse Events: Reporting any adverse events or product complaints to the FDA and assisting in the resolution of such issues.

6. Product Recalls: Coordinating with the FDA on product recalls or corrective actions, including managing recall processes and communications.

7. Regulatory Updates: Keeping the manufacturer informed of any changes in FDA regulations or requirements that may affect their products.

8. Document Availability: Ensuring that required documents and records are available for FDA inspection or review.

The U.S. Authorized Representative plays a critical role in navigating regulatory requirements and ensuring smooth interaction between the FDA and the foreign manufacturer

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