Renewal Season is Here! FY 2027 Device Establishment Registration and Listing

On October 1, 2026, FDA’s 2027 fiscal year began and with it the renewal period for device establishment registrations. Companies have until December 31, 2026, to pay the annual registration fee ($13,785), review their current registration information and device listings, and make any necessary updates for the coming year. Failing to properly register and list medical devices is a violation of the Federal Food, Drug, and Cosmetic Act, and can result in civil and criminal penalties.

We can help your company with the necessary registration and listing activities, such as setting up your profile for initial registration, evaluating whether you need to register and what products you need to list, or renewing for the 2027 fiscal year. We can offer predictable flat fee service rates, and provide ongoing updates throughout the year or annual U.S. Agent services.