FURLS Registration and Device Listing

🇺🇸 United States · FDA medical devices · Reviewed 25 August 2026

Jurisdiction🇺🇸United StatesFederal scope

FURLS, DRLM, registration and listing at a glance

What establishment registration and device listing each record

Establishment registration is facility-level. The record includes the establishment’s name and mailing address, trade names, the owner/operator, an official correspondent and the activities performed at that location. It tells FDA where regulated device work is being done and who is responsible for maintaining the record.

Device listing is product-level, but it is not merely a product name. Under 21 CFR 807.25, a listing can include the establishments under the same owner/operator where the device is manufactured or otherwise processed, the product code, proprietary names, the applicable premarket submission number, and each activity performed on the device at each establishment.

That means a complete evidence check has two dimensions:

1. Facility match. The legal entity, physical establishment and activity must fit the party represented in the seller’s documents.
2. Device match. The listed device, proprietary name, classification and premarket basis must fit the product being offered.
3. Current status. The registration must be active for the current fiscal year and the listing must reflect current information.
4. Separate marketing basis. If the device needs 510(k), De Novo, PMA or another authorization, that record must exist independently.

The broader distinction is covered in FDA facility registration vs product listing. The terminology comparison NDC vs CPLN vs FURLS shows why FURLS belongs to a different FDA workflow from drug and cosmetic identifiers.

Who must register, list and pay the fee

The obligation follows the establishment’s activity, not a generic label such as “seller” or “brand.” FDA’s current role table distinguishes manufacturers, specification developers, contract operations, importers, distributors and exempt activities. Do not register a party merely because a marketplace form asks for an FDA number.

This is a working summary, not a substitute for the full FDA table. Foreign establishments, export-only activities, complaint-file roles and specialized operations have additional rows and details. Check the exact activity before filing.

Initial registration, annual renewal and updates

A new establishment subject to the rule registers within 30 days after entering a covered operation and submits listing information at that time. Every registered establishment must complete annual registration for each FDA fiscal year between October 1 and December 31. During the same window, the owner/operator reviews and updates listing information and confirms its accuracy even when nothing changed.

Registration changes must generally be reported within 30 days. Listing changes can be made when a device enters commercial distribution, a listed device changes, or a device leaves distribution. If required information is not submitted on time, the establishment can be placed in “failed to register” or “failed to list” status and may not appear as active until FDA processes the missing information.

FDA’s online process has two parts: pay the current annual establishment fee through the Device Facility User Fee system, then complete the electronic registration and listing steps in FURLS/DRLM. Registration is not complete merely because payment was made. FDA says the firm must pay, submit the electronic information and receive confirmation that the requirements were met.

Owner/operator, official correspondent and U.S. agent

A U.S. agent does not become responsible for adverse-event reporting or for submitting a 510(k) merely by accepting the appointment. FDA describes those responsibilities separately. For foreign firms, do not treat “U.S. agent,” “initial importer” and “official correspondent” as interchangeable titles.

Registration number, FEI, owner/operator number and listing number

FURLS creates and displays several identifiers. They refer to different records:

• Registration or FEI number: the facility identifier shown in FDA’s public registration database. FDA materials describe the FEI as the device establishment registration number after assignment.
• Owner/operator number: identifies the responsible owner/operator account relationship, not a specific device.
• Device listing number: identifies the device listing record inside DRLM. FDA’s public database exposes searchable device and establishment information, but FDA guidance states that listing numbers themselves are not publicly released; the owner/operator or official correspondent can download and share listing information.
• Premarket submission number: a separate 510(k), De Novo, PMA, HDE or other number where the device requires a premarket route.
• Product code and proprietary name: help connect the listing to the correct device classification and marketed name.

FDA’s public Establishment Registration & Device Listing database is useful for verification, but it is not instantaneous. FDA notes a delay between submission and public display, and its search page says releasable data are updated weekly, usually on Monday. A recent submission may therefore need authenticated DRLM evidence while the public result catches up.

FURLS does not replace 510(k) or another premarket route

A device listing records a device that is being commercially distributed. When marketing authorization is required, the listing includes the relevant premarket submission number. The sequence matters: the required 510(k), De Novo, PMA or other route is handled separately; listing does not create the clearance or approval.

For the decision point, use 510(k) required vs exempt. For platform-specific problems, see Amazon medical-device 510(k) restriction and TikTok Shop medical devices: 510(k) and FURLS required.

What a marketplace may ask you to upload

A marketplace can impose a document review that goes beyond the federal filing mechanics. That is a platform rule, not a new FDA record. The current TikTok Shop U.S. medical-device policy, for example, asks manufacturers, importers and repackers for proof of establishment registration and device listing from FURLS. It specifies authentic, unmodified screenshots showing the establishment name and physical address, operation type and current validity, and separately requests 510(k) documentation or proof of exemption for Class II devices.

That platform wording illustrates why a generic “FDA certificate” is the wrong response. A reviewer may need two distinct FURLS records, a premarket record, product and label images, and a match between all names and product details. Supplying one screenshot with an FDA number does not answer every field.

Pre-submission check for FURLS evidence

1. Identify the applicant’s real role. Manufacturer, specification developer, contract operation, initial importer, reseller and distributor do not have the same duties.
2. Confirm the establishment is active for the current fiscal year. Do not reuse last year’s registration screen.
3. Match the legal name and physical address. Explain legitimate differences between the seller, owner/operator, establishment, importer and brand owner instead of hiding them.
4. Match the operation type. A contract manufacturer record does not automatically prove that the brand owner itself is registered.
5. Match the device listing. Check product code, proprietary name, listing owner and connected establishment activity.
6. Check the premarket basis separately. Provide the matching 510(k), De Novo, PMA or exemption evidence when the product requires it.
7. Use original evidence. Keep screenshots complete, legible and unedited and preserve visible FDA context if the platform asks for it.
8. Explain a recent submission carefully. FDA’s public data can lag. Use authenticated DRLM evidence and the FDA confirmation without claiming the record is public before it is.
9. Remove approval and certificate claims. Say “registered establishment” or “listed device,” not “FDA approved,” “FDA certified” or “FURLS certified.”

Frequently asked questions