U.S. Device Agent

FDA Registration & Listing

Medical device establishments that are required to register with the U.S. Food and Drug Administration (FDA) must complete their annual registration for each fiscal year between October 1 and December 31.
Foreign establishments must also register with the FDA before exporting medical devices to the United States.
Registration and device listing information is submitted electronically through the FDA Unified Registration and Listing System (FURLS) and Device Registration and Listing Module (DRLM).

How USDeviceAgent.com Can Help

USDeviceAgent.com is an independent company and is not affiliated with, endorsed by, or acting on behalf of the FDA.
Navigating the FDA registration and listing process can be time-consuming and complex, particularly for companies outside the United States. We assist foreign medical device establishments with the registration process and help ensure the required information is submitted accurately and efficiently.
You may complete the registration process directly through the FDA by visiting its Device Registration and Listing website.
If you would prefer assistance, USDeviceAgent.com can help with the registration process or, when appropriately authorized, complete registration and listing activities on your behalf.

U.S. Agent Requirements for Foreign Medical Device Establishments

Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a medical device that is imported or offered for import into the United States must designate a United States Agent (U.S. Agent).
Each foreign establishment may designate only one U.S. Agent.
The U.S. Agent is identified electronically as part of the establishment's FDA registration. The foreign establishment may also designate its U.S. Agent as its Official Correspondent, although this is not required.

U.S. Agent Verification

When a foreign establishment designates a U.S. Agent, the FDA sends an electronic verification request to that agent.
The U.S. Agent must confirm that it has agreed to serve as the establishment's representative and liaison with the FDA. If the designated U.S. Agent declines the appointment or does not respond to the FDA's verification request within 10 business days, the foreign establishment must designate another U.S. Agent.

Responsibilities of a U.S. Agent

A U.S. Agent must either reside in the United States or maintain a place of business in the United States. A post office box or answering service alone does not satisfy FDA requirements.

The U.S. Agent must be reachable during normal U.S. business hours, either directly or through an employee.

The responsibilities of the U.S. Agent include:

Assisting the FDA with communications involving the foreign establishment
Responding to FDA questions regarding the foreign establishment's medical devices that are imported or offered for import into the United States
Assisting the FDA in scheduling inspections of the foreign establishment
Receiving information or documents from the FDA when the FDA is unable to contact the foreign establishment directly or expeditiously

When the FDA provides information or documents to the designated U.S. Agent under these circumstances, it is considered equivalent to providing that information directly to the foreign establishment.

What a U.S. Agent Is Not Responsible For

The U.S. Agent's regulatory responsibilities are limited.
A U.S. Agent is not responsible for reporting adverse events under the Medical Device Reporting requirements of 21 CFR Part 803 and is not responsible for submitting 510(k) Premarket Notifications under 21 CFR Part 807, Subpart E.
Additional regulatory and registration services may be provided separately when agreed upon and when the appropriate authorization has been established.

Important FDA Registration Notice

Registration of a medical device establishment or listing of a medical device with the FDA does not constitute FDA approval, clearance, certification, or authorization of the establishment or its products. The FDA does not issue medical device establishment registration certificates and does not certify third-party registration services.

USDeviceAgent.com is an independent U.S. Agent and regulatory support provider and is not affiliated with the U.S. Food and Drug Administration.