FDA US Agent Services, Backed by Former Regulators and Global Expertise

Any foreign company that wants to market regulated products in the United States must appoint an FDA U.S. Agent. This includes:

• Foreign manufacturers producing devices for the U.S. market.
• Foreign contract manufacturers making devices for U.S. distribution.
• Foreign specification developers that design or define device specifications for U.S. sales.

FDA requires all non-U.S. establishments to designate a U.S. Agent so the agency has a reliable contact within the United States. Without one, FDA may refuse registration, which prevents products from being legally imported or sold in the U.S.

A U.S. Agent serves as the official point of contact between FDA and a foreign company. Their responsibilities include:

• Acting as a liaison for all FDA communications.
• Answering FDA questions about devices.
• Helping schedule and facilitate inspections of foreign facilities.
• Ensuring establishment registrations and device listings are accurate and up to date.

To qualify, an FDA U.S. Agent must:

• Have a permanent physical address in the United States.
• Be available during normal U.S. business hours to communicate with FDA.

A distributor markets and sells your products in the U.S., but this does not meet FDA’s requirement for a U.S. Agent. An FDA U.S. Agent is a separate, legally required role responsible solely for official communication with FDA — even if you already have a distributor.

You designate your FDA U.S. Agent during the FDA Establishment Registration process. If you already have a registration, you can update it to include your chosen U.S. Agent.