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If your company is based outside the United States and you export food, drugs, medical devices, or cosmetics to the US market, the FDA requires you to appoint a US Agent before your products can legally enter the country. This is not a formality. Without a designated US Agent, foreign establishments cannot complete FDA registration, and shipments can be refused at US ports of entry.
What is a US FDA Agent?
A US FDA Agent, often called the US Authorized Representative, is a person or company that resides in the United States or maintains a physical place of business there. The agent acts as the official communication link between the FDA and your foreign establishment. Each foreign establishment may designate only one US Agent, and the designation is submitted electronically through the FDA Unified Registration and Listing System (FURLS) during establishment registration. The agent must confirm consent through an automated FDA email, and if they fail to respond within 10 business days, the FDA contacts the establishment to confirm the designation.
Who needs a US FDA Agent?
- Food facilities: Foreign facilities that manufacture, process, pack, or hold food for US consumption (21 CFR 1.227).
- Drug establishments: Foreign manufacturers, repackers, and relabelers (21 CFR 207.69).
- Medical device establishments: Foreign manufacturers, specification developers, and other registered establishments (21 CFR 807.40).
- Cosmetics facilities: Foreign facilities subject to registration under MoCRA, in force since 2024.
What does the US Agent actually do?
The US Agent receives all official FDA communications, including inspection notices and questions about your products, and must be reachable by phone during normal US business hours. A simple answering service does not qualify. The agent also assists the FDA in scheduling inspections of your foreign facility and can receive documents on your behalf. Importantly, the US Agent role is a communication role. It does not automatically make the agent your importer, distributor, or official correspondent, although you may choose to combine these roles.
Main Regulatory Responsibilities
- Assist FDA communications with the foreign establishment.
- Respond to FDA questions concerning the foreign establishment or its devices.
- Assist FDA in arranging inspections of the foreign establishment.
- Receive FDA information or documents when direct communication with the manufacturer is unsuccessful or delayed.
- Maintain accurate and current contact information.
What is new for 2026?
Three updates matter right now. First, the FY2026 medical device establishment registration fee is USD 11,423, valid from October 1, 2025 to September 30, 2026, with annual renewal open from October 1 to December 31 each year. Second, 2026 is a biennial renewal year for food facilities, so foreign food facilities must renew registration between October 1 and December 31, 2026, and reconfirm their US Agent details. Third, on June 29, 2026 the FDA published a proposed rule that would extend establishment registration, product listing, and the US Agent requirement to foreign tobacco product manufacturers for the first time, with comments open through September 14, 2026.
Common compliance mistakes
The most frequent gaps we see are outdated agent contact details, which for device establishments must be corrected within 10 business days of any change, missed renewal windows, and confusing the US Agent with the EU Authorized Representative. These are separate roles under separate laws, and one cannot substitute for the other.
How NexorTest can help
NexorTest Technologies provides US FDA Agent and Authorized Representative services across 50+ countries, alongside FDA establishment registration and listing, ISO 13485 QMS support, regulatory submissions, product testing, and cybersecurity for SaMD. One coordinated team keeps your registrations current, your renewals on schedule, and your FDA communications answered on time.Contact us to appoint a responsive US Agent before the October renewal window opens.
