FDA U.S. Agent (US Agent) Services

Who Needs a U.S. Agent?

Any foreign company that intends to sell drugs, food, or medical device products in the United States must appoint a U.S. agent. In most cases, the FDA communicates with the company through its U.S. agent.

The FDA communicates with foreign companies via their U.S. agent. Your U.S. agent must understand the importance of regulatory communication and respond promptly when necessary.

All regulatory communication goes through the U.S. agent. Your agent should be able to handle FDA communications effectively and relay any information received from the FDA without delay.

For generic drugs, the U.S. agent handles controlled communications, so your agent should be familiar with the controlled communication filing process.

Responsibilities of a U.S. Agent

①　Act as an intermediary between the FDA and the foreign company.

②　Assist in answering any questions regarding the foreign establishment—this is one of the key responsibilities of a U.S. agent.

③　Help the FDA arrange inspections of the foreign establishment.

④　Represent the foreign company and receive documents and information from the FDA on their behalf.

How Long Does It Take to Appoint a U.S. Agent?

JJR LAB can complete the U.S. agent appointment process the same daythrough our online system.

You can fill out the U.S. agent application form and make the payment. Once we receive the completed form and payment, we will provide you with the U.S. agent details to include in your regulatory submissions or registrations.

Changing U.S. Agent Information – What Are the Implications?

Changing your U.S. agent does notaffect your registration or business. You can update the U.S. agent name in your FDA registration at any time.

If you want to change the U.S. agent in your food, drug, or medical device registration, JJR LAB can assist you free of charge. Contact us to update your U.S. agent information.

How to Change U.S. Agent Information in FDA Registration

①　Log in to your account

②　Update the information in the U.S. agent section

③　Submit the registration

④　The U.S. agent will receive a confirmation notice from the FDA

The process to complete a U.S. agent change takes less than one business day.