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US Agent Services
FDA-Required US Agent for Foreign Medical Device Manufacturers
Do You Need a US Agent for FDA Registration?
Under 21 CFR Part 807, every foreign medical device manufacturer that registers an establishment with the FDA must designate a US Agent. This is a legal requirement not optional. Sequence Group provides this service with the regulatory expertise to ensure your FDA registration is accurate, timely, and compliant.
What is a US Agent?
The FDA requires that foreign establishments designate a US Agent an individual or company physically located in the United States to serve as the official point of contact with the FDA. The US Agent is responsible for facilitating communication between the foreign manufacturer and the FDA, including responding to regulatory inquiries, coordinating inspections, and handling urgent safety communications.
Choosing the right US Agent is critical. Your US Agent must be reachable during US business hours and have the expertise to understand and respond to FDA communications accurately. Sequence Group brings over 15 years of FDA regulatory experience to this role.
US Agent & FDA Registration Services
Who Needs a US Agent?
- Foreign manufacturers exporting medical devices to the US market
- Companies seeking FDA 510(k) clearance or PMA approval from outside the US
- Foreign-owned companies registering a US establishment for the first time
- Manufacturers whose current US Agent is unavailable or unresponsive
- Companies that have received an FDA warning related to registration compliance
Ready to designate your US Agent?
Contact us for a free consultation. We can have you registered quickly.