FDA Registration / U.S. Agent
Establishments that produce and distribute medical devices that are marketed in the United States must register with the FDA through a process known as “Establishment Registration.”
The establishment registration process allows the FDA to be notified of the location of medical device manufacturing facilities and importers. It is important to note that registration of an establishment is not equivalent to FDA clearance or approval to market a medical device. Unless the product is classified as exempt, 510(k) premarket clearance or PMA approval from the FDA is required before the medical device can be commercially distributed in the United States.
Most medical device establishments required to register with the FDA must also identify the devices they have in commercial distribution, through a process known as “Medical Device Listing”. The medical device listing process allows the FDA to stay advised of types of medical devices that an establishment manufacturers and/or markets.
A variety of types of businesses are required to complete the establishment registration process, including medical device manufacturers, contract sterilizers, contract manufacturers, single-use re-processors, specification developers, and initial distributors. Aptiv Solutions can help you to define your medical device establishment registration requirements and guide you through the electronic establishment registration and medical device listing process, which uses the FDA Unified Registration and Listing System (FURLS).
FDA United States Agent for Foreign Establishments
All foreign (non-U.S.) establishments must assign a United States agent and notify the FDA of the agent’s name, business name, address, phone number, and email address. Even if an establishment manufactures various medical devices, drugs, and/or biological products, each establishment can identify only one United States agent. The United States agent must either reside in the U.S. or maintain a place of business in the U.S.
The responsibilities of the United States agent are limited. They include assisting FDA in communications with the foreign establishment, responding to questions about imported products, and assisting the FDA to schedule facility inspections.
When to Complete the Medical Device Establishment Registration and Listing
U.S. based establishments must register within 30 days of commercialization of a medical device, including the export of devices outside of the U.S. If you are required to list your devices, you must submit device listing information at the time of initial registration.
Foreign establishments must register and notify the FDA of their United States agent, as well as list their devices prior to exporting to the United States.