In addition to establishment registration, all medical devices marketed in the U.S. must be individually listed with the FDA through FURLS. Device listings must include product codes, intended use, and regulatory status. We prepare and submit accurate device listings for all device classes.
Device Listing Submission (FURLS)
We prepare and submit complete medical device listings through the FDA’s FURLS/CDRH system, including all required product codes and regulatory information.
- FDA product code identification
- Device classification & listing
- Proprietary name registration
Annual Device Listing Updates
Device listings must be reviewed and updated annually, including changes to marketed devices, discontinued products, and new products added to your portfolio.
- Annual listing review & update
- New device additions
- Discontinued device removals
- Design change listing updates
IVD Device Listing
In Vitro Diagnostic (IVD) devices have specific classification and listing requirements under CDRH. We specialize in IVD device registration and listing.
- IVD device classification support
- Intended use statement review
- 510(k) & De Novo reference listing
UDI (Unique Device Identifier) Support
Medical devices must carry a Unique Device Identifier (UDI) label and be listed in the Global UDI Database (GUDID). We help coordinate UDI compliance.
- GUDID database submission
- UDI label format guidance
- Direct mark UDI support
- UDI exemption assessment
Ready to Get Your Devices Listed?
We handle your FURLS device listing, IVD-specific requirements, and UDI/GUDID submissions, so every product you market is accounted for and current.
Medical Device Listing FAQs
Yes. Establishment registration covers your facility. Device listing covers each specific product you market in the U.S., including product codes, intended use, and regulatory status. Both are filed through FURLS and both renew annually.
IVDs fall under CDRH like other devices, but they have their own classification nuances. We handle IVD-specific listing requirements, including referencing your 510(k) or De Novo submission number where applicable.
Device listing identifies the products you market, filed through FURLS. UDI/GUDID submission provides the unique identifier data for each device, filed separately to FDA’s Global Unique Device Identification Database. Most manufacturers need both kept current.
Annually, during FDA’s renewal window of October 1 through December 31, and any time you add a new device, discontinue one, or make a material design change.
Marketing a device that isn’t properly listed can put your FDA compliance status at risk. We track your product changes throughout the year so listings stay current, not just during the annual renewal window.