What is medical device product listing and when is it required?

Device product listing is the process of registering specific medical devices with FDA under 21 CFR Part 807. Every person who owns or operates an establishment that manufactures, distributes, repackages, or relabels medical devices for commercial distribution in the U.S. must list those devices with FDA. Listing must be completed before the device is introduced into commercial distribution. Failure to list can result in FDA enforcement actions including warning letters, seizure, and injunction.

How do I access FURLS and submit a device listing?

FURLS (Unified Registration and Listing System) is FDA's electronic portal for device establishment registration and product listing. Access requires an FDA Industry Systems account and a DUNS number. Listing submissions through FURLS include product codes, proprietary device names, premarket submission numbers (if applicable), and establishment information. Assurentry handles the entire FURLS submission process, eliminating the need for your team to navigate the system directly.

How do I find the correct FDA product code for my device?

FDA assigns product codes based on device type and intended use. The correct code can be found using FDA's Product Classification Database, which cross-references device descriptions, regulation numbers, and classification panels. Selecting the wrong product code can trigger incorrect premarket requirements or inspection scrutiny. Assurentry uses FDA's classification tools and regulatory expertise to determine the accurate product code for your device.

When must I list my device with FDA?

Devices must be listed before they are introduced into commercial distribution in the United States. For new establishments, initial listing must be submitted within 30 days of beginning operations. Existing establishments must update listings annually during the October–December registration window and whenever new devices are added to the portfolio. Assurentry ensures timely listing submissions aligned with FDA's required timelines.

What is the difference between 510(k) exempt and 510(k) required device listing?

510(k) exempt devices (most Class I and some Class II) can be listed and commercially distributed without a premarket notification submission. 510(k) required devices must receive FDA clearance before commercial distribution, and the listing must reference the 510(k) clearance number. The exemption status is determined by the device's product code and classification regulation. Assurentry verifies your device's 510(k) status and ensures the listing accurately reflects the premarket pathway.

Do foreign device establishments need to list their products with FDA?

Yes. Foreign establishments that manufacture, repack, relabel, or distribute devices imported or offered for import into the U.S. must register with FDA and list all applicable devices under 21 CFR Part 807. Foreign establishments must also designate a U.S. Agent. Assurentry provides device listing, establishment registration, and U.S. Agent services as an integrated package for foreign device companies.

What are the annual update requirements for device listings?

Device listings must be reviewed and updated annually during the October–December registration and listing period. Updates include adding newly marketed devices, removing discontinued devices, updating proprietary names or device characteristics, and verifying premarket submission references. FDA expects listings to accurately reflect the current device portfolio at all times. Assurentry manages annual listing reviews and updates as part of ongoing compliance support.

How much does device product listing cost with Assurentry?

Assurentry charges $199 per device for standalone medical device product listing, including product code determination, classification panel identification, 510(k) pathway verification, FURLS submission, and establishment linkage confirmation. Annual listing updates are included for the first year. Volume pricing is available for companies with large device portfolios.

Device Listing • Official FDA Process

FDA Medical Device Product Listing
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Standalone device product listing through FDA's FURLS system, including product code determination, classification panel identification, and premarket pathway guidance under 21 CFR Part 807.

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Device Assessment

We evaluate your device to determine the correct FDA product code, classification panel, and applicable regulation number using FDA's Product Classification Database.

Pathway Determination

We determine whether your device is 510(k) exempt or requires premarket notification, and verify the listing requirements for your specific device classification.

FURLS Submission

We submit your device listing through FDA's FURLS system with accurate product codes, proprietary names, and establishment linkage information.

Confirmation & Maintenance

We confirm successful listing, verify establishment registration linkage, and manage annual listing updates as your device portfolio changes.

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FDA Medical Device Product Listing Service

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What's Included

Product code determination and classification lookup
Classification panel and regulation number identification
510(k) exempt vs. required pathway determination
FURLS electronic listing submission
Establishment registration linkage verification
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