US Agent and Correspondent

U.S. Agent Services for Non-US Manufacturers

Medical Devices and Pharma offers U.S. Agent and Correspondent services to our clients. Click here to request more information.

When a U.S. company serves as an FDA U.S. agent/correspondent for a foreign device manufacturer, it takes on several important roles and responsibilities to ensure compliance with regulations and facilitate communication with the Food and Drug Administration (FDA). Here’s an overview of the typical roles and responsibilities:

FDA Communication

The U.S. agent serves as the primary point of contact between the FDA and the foreign device manufacturer. They receive communications from the FDA on behalf of the foreign manufacturer and may also communicate with the FDA on behalf of the manufacturer regarding regulatory matters, submissions, and compliance issues.

Facilitation of Regulatory Submissions

The U.S. agent assists the foreign device manufacturer in preparing and submitting required documents to the FDA. This may include applications for device marketing authorization, premarket notifications (510(k)), premarket approval (PMA) applications, investigational device exemptions (IDE), or other regulatory submissions.

Record Keeping and Reporting

The U.S. agent is responsible for maintaining accurate records of communications and regulatory submissions between the foreign manufacturer and the FDA. They may also be required to submit reports to the FDA on behalf of the foreign manufacturer, such as adverse event reports or annual registrations.

Compliance Assistance

The U.S. agent helps ensure that the foreign device manufacturer complies with FDA regulations and requirements. This involves staying up-to-date with regulatory changes, providing guidance on compliance matters, and advising the manufacturer on steps needed to maintain compliance with applicable regulations.

Emergency Response Coordination

In the event of a device recall or other emergency situation involving the foreign manufacturer’s products, the U.S. agent may assist in coordinating communication between the manufacturer, the FDA, and other relevant parties to ensure a timely and appropriate response.

Representation in FDA Inspections

If the FDA conducts an inspection of the foreign device manufacturer’s facilities, the U.S. agent may be asked to represent the manufacturer during the inspection process. This involves facilitating communication between the FDA inspector and the manufacturer, providing access to requested records and facilities, and ensuring that any observations or findings are appropriately addressed.

Legal Obligations

The U.S. agent must comply with all legal obligations associated with serving as an agent for a foreign device manufacturer, including maintaining confidentiality of sensitive information and adhering to relevant laws and regulations governing medical devices and FDA interactions.

Conclusion

Overall, the role of a U.S. agent for a foreign device manufacturer is crucial in ensuring compliance with FDA regulations and facilitating smooth communication between the manufacturer and the regulatory authorities in the United States.

Medical Devices & Pharma provides services as a U.S. Agent/Correspondent for foreign manufacturers. To request more information, click this link to access our US Agent Information Request Form.