U.S. Agent, Initial Importer and FDA Representation for Medical Devices and IVDs

Accessing the U.S. Market

Foreign medical device manufacturers marketing products in the United States must appoint a U.S. Agent in accordance with 21 CFR Part 807.40, and in many cases designate an Initial Importer for logistics and regulatory compliance purposes.

The U.S. Agent acts as the official point of contact between the manufacturer and the FDA, facilitating communication and supporting regulatory obligations.

ALTRION provides U.S. Agent representation and regulatory support, ensuring direct interaction with the FDA and oversight of product importation and compliance activities.

Our Services

U.S. Agent Appointment & FDA Registration

• Appointment of U.S. Agent
• FDA Establishment Registration
• Assignment of FEI and Owner/Operator numbers

Device Listing & Regulatory Support

• Support for Establishment Registration and Device Listing
• Review and update of 510(k) or De Novo submissions

Importation & Logistics Coordination

• Coordination with customs and importation partners
• Support for compliant product entry into the U.S. market

Initial Importer Services (Optional)

• Designation of Initial Importer for distribution purposes

Regulatory Communication

• Assistance during FDA inspections
• Support for FDA communications and requests

Our Approach

We ensure that manufacturers entering the U.S. market have a reliable regulatory presence, clear communication with the FDA, and structured support for compliance and importation activities.