FDA U.S. Agent Services by Wesolve

UM can serve as your FDA U.S. Agent, facilitating regulatory compliance for foreign medical device manufacturers operating in the United States.

Why Do You Need an FDA U.S. Agent?

As mandated by the FDA, any foreign establishment involved in the production, preparation, or processing of a device for import into the U.S. must designate a United States agent. This role is critical for maintaining legal and effective communication with the FDA.

Understanding 21 CFR 807 and the Unified Registration and Listing System (FURLS)

21 CFR 807 and the FDA Unified Registration and Listing System (FURLS) outline the registration process and requirements for foreign establishments, including U.S. Agent designation. Each foreign establishment may designate only one U.S. Agent and may optionally appoint the agent as the official correspondent.

U.S. Agent Responsibilities

The U.S. Agent must have a U.S.-based residence or place of business and cannot use just a P.O. box or an answering service. They must be available during normal business hours to:

• Assist the FDA in communications with the foreign establishment.

• Respond to questions about the imported devices.

• Assist the FDA in scheduling inspections.

Note that U.S. Agents are not responsible for adverse event reporting or submitting 510(k) Premarket Notifications.

Consent and Verification Process

Upon designation, the U.S. Agent will undergo an automated verification process to confirm their agreement to serve as the U.S. Agent. Failure to confirm within 10 business days will necessitate the designation of a new U.S. Agent.

Key Features of Wesolve's FDA U.S. Agent Services

• Compliance and Regulatory Communications: Seamless interaction with FDA for regulatory matters.

• FDA Inspections: Effective preparation and facilitation of FDA inspections.

Conclusion

UM's FDA U.S. Agent Services are essential for any foreign medical device company wishing to operate in the United States. With our expertise, you can ensure compliance with all FDA requirements, thereby promoting a smooth and transparent business operation.