Manufacturers, importers, and distributors of medical devices sold in the U.S. must register annually with the FDA’s CDRH through the FURLS (Unified Registration and Listing System) portal. We manage the entire filing process on your behalf.
Initial Device Establishment Registration
New medical device establishments must register with the FDA’s CDRH before distributing devices in the U.S. We handle Class I, II, and III device registrations.
- Class I, II & III device support
- Domestic & foreign facilities
- DUNS number coordination
- U.S. Agent designation included
Annual Renewal
Device establishment registrations must be renewed annually between October and December. We file on time every time so your registration never lapses.
- Advance deadline reminders
- Updated establishment information
- FURLS renewal submission
- Annual user fee payment guidance
510(k) & PMA Coordination
Class II devices require 510(k) premarket notification and Class III devices require PMA. We coordinate device registration in alignment with your premarket submission status.
- 510(k) clearance reference in listing
- PMA approval reference support
- Exempt device identification
- Device classification guidance
Registration Amendments
Changes to your device establishment new personnel, locations, or device activities require timely FURLS updates. We file all amendments promptly.
- Facility address amendments
- Ownership & contact updates
- Device activity type changes
- New establishment additions
Ready to Register Your Device Establishment?
We handle the FURLS filing, your U.S. Agent designation, and your annual renewal, so you’re never tracking deadlines yourself.
Establishment Registration FAQs
Any manufacturer, importer, repackager, or distributor of medical devices sold in the U.S., whether based domestically or abroad. Foreign establishments also need a designated U.S. Agent as part of registration.
FURLS stands for FDA Unified Registration and Listing System, the FDA’s online portal for submitting and maintaining device establishment registration and listing information. It’s also used by food facilities and tobacco product manufacturers for their own registrations, not just medical devices.
Annually, during the FDA’s renewal window of October 1 through December 31. Missing this window can put your registration status, and your ability to legally distribute in the U.S., at risk.
It depends on your device class. Class II devices generally require 510(k) premarket notification, and Class III devices generally require PMA approval, though some devices are exempt. We can help identify where your device falls.
Any change, address, ownership, contact, or device activity type, needs a timely FURLS amendment. We file these as they come up rather than waiting for the annual renewal.