Owners/operators of establishments involved in the production and distribution of Medical Devices intended for use in the United States are required to register annually with the FDA. This process is known as establishment registration (21 CFR Part 807). Additionally, they are required to list the devices that are manufactured in such facilities with the FDA.
Furthermore, foreign establishments involved in the manufacture, preparation, […] or processing of a device imported into the United States must designate a U.S. Agent for that establishment. Information regarding the designated U.S. Agent is submitted electronically using the FDA Unified Registration and Listing System (FURLS system) during the establishment registration process. Each foreign establishment may designate only one U.S. Agent.
FDA collects an annual Establishment Registration fee that must be paid between October 1st and December 31st of each year.
During the Establishment Registration renewal, it is necessary to confirm/modify/delete the data present in the FDA database, including the device listing and U.S. Agent information.
The annual Establishment Registration Fee for the fiscal year 2020 is $5,236 and is not eligible for a reduced small business fee (i.e. is the same amount as the standard fee).
All registration and listing information must be submitted electronically, unless a waiver has been granted.