What is a FDA (Food & Drug Administration) US Agent?

An FDA Agent, also known as a U.S. Agent, is a person or company that is designated by a foreign establishment to represent the establishment in the United States for all communications from the FDA. This includes emergency communications, responding to questions concerning imported drugs, assisting the FDA in scheduling inspections, and receiving information and documents from the FDA on behalf of the foreign registrant.

FDA Agents are required for all registered foreign drug manufacturing establishments, as well as for foreign medical device establishments. The FDA Agent must be a resident of the United States and must be available to answer the phone or have an employee available to answer the phone during normal business hours.

Some of the specific roles and responsibilities of an FDA US Agent may include:

1. Assisting with communication: The FDA US Agent helps facilitate communication between the foreign company and the FDA. They may receive and respond to FDA inquiries, notifications, and requests on behalf of the foreign company.
2. Registering with the FDA: For certain regulated products, such as medical devices and food facilities, the foreign company must register with the FDA. The FDA US Agent may assist in this registration process.
3. U.S. Agent Authorization: The foreign company must authorize the FDA US Agent to act on their behalf in matters related to FDA regulations and compliance. This authorization is typically a formal agreement between the two parties.
4. Providing an address for FDA correspondence: The FDA US Agent provides a U.S. address where the FDA can send regulatory correspondence and official communications.
5. Assisting with inspections: In the event of an FDA inspection of the foreign company's facilities, the FDA US Agent may be required to assist with the inspection process and serve as a contact point during the inspection.

Foreign companies seeking to import regulated products into the United States are typically required to designate an FDA US Agent as part of their regulatory obligations. This helps the FDA ensure that products entering the U.S. market meet the necessary safety and quality standards and allows for efficient communication between the FDA and foreign entities.

Important notes:

• The FDA US Agent does not assume legal liability for the foreign company's products, and their role is primarily administrative and communicative. The foreign company remains responsible for ensuring that its products comply with FDA regulations.
• The FDA US Agent designation is established through an agreement between the foreign company and the chosen FDA US Agent.

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Kimpalou Consulting & Services can act as FDA US Agent for foreign medical device companies.

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FDA U.S. Agent Appointment Form

FDA U.S. Agent Service Offering - KC&S