How long does FDA registration last?

FDA medical-device registration is not a permanent license. Registered establishments must renew annually, pay the applicable fiscal-year establishment fee, review their registration information, and verify or update their device listings.

The FDA annual registration period runs from October 1 through December 31. Establishment registration is based on the federal fiscal year, which runs from October 1 through September 30, although FDA states that it continues to consider an establishment’s registration active through the end of the calendar year.

New establishments must generally submit registration and listing information within 30 days of beginning a registrable activity or placing a device into commercial distribution. Foreign establishments must register before exporting devices to the United States, and domestic initial importers must register before importing them. If a device requires 510(k) clearance, De Novo authorization, PMA approval, or another premarket decision, that decision ordinarily must be obtained before the device is listed and commercially distributed.

Registration and listing information can be updated throughout the year when facilities, proprietary names, manufacturing sites, importers, or commercial-distribution status change. Annual renewal is still required even if no changes occurred.

Failure to renew can cause the registration to become inactive and may lead to import detention or other compliance consequences. FDA’s annual registration instructions should be followed for the applicable fiscal year.