Device listing is the FDA requirement to report each device model you commercially distribute in the United States. Each listing is tied to a product code — a three-letter identifier that places the device in its regulatory classification. Listing must be updated within 30 days of introducing a new device, discontinuing one, or changing intended use.
Most medical device manufacturers understand registration — the process of telling FDA who and where you are. Device listing is the companion obligation: telling FDA what you make and distribute. While registration is establishment-level, listing is product-level. Together, they give FDA the visibility it needs to identify which firms produce which devices and to administer surveillance and enforcement activities.
What Is Device Listing?
Device listing is a manufacturer's or distributor's obligation under 21 CFR Part 807 to notify FDA of each medical device it introduces into commercial distribution in the United States. The listing is submitted through FURLS (FDA Unified Registration and Listing System) and links your establishment registration to each device model you market.
Unlike registration, which is annual, listing updates are event-driven. You must list a device within 30 days of first commercial distribution. You must update a listing within 30 days if you discontinue distribution or if the device's characteristics change in a way that affects its product code. Annual renewal of the listing occurs alongside establishment registration each October–December, even if no substantive changes occurred.
Product Codes: What They Are and How They Are Assigned
An FDA product code is a three-letter alphanumeric identifier that classifies a device by type, intended use, and regulatory class. Each product code maps to a specific 21 CFR regulation section, a device class (I, II, or III), and a premarket submission requirement (exempt, 510(k), PMA, or De Novo). Product codes also link to applicable performance standards, guidance documents, and special controls.
When you submit a device listing in FURLS, you select the product code that most accurately describes your device. Selecting the correct product code matters because it determines: (1) whether premarket clearance or approval is required before marketing, (2) which FDA regulation and guidance documents apply, and (3) which submission type FDA expects if review is required.
If no existing product code clearly matches your device, this may indicate that your device is genuinely novel and may require a De Novo classification request to create a new product code category. A 513(g) classification request can help identify the appropriate product code before you proceed.
What Information Must a Device Listing Include?
A device listing submission requires: the proprietary (trade) name of the device, the product code, a brief device description, the premarket submission number (510(k), PMA, De Novo, or HDE) if the device requires premarket review, the UDI device identifier if applicable, and the registration number of each establishment involved in manufacturing. If multiple sites manufacture the device, each site's registration number is included.
Contract manufacturers and specification developers each have their own listing obligations. If you design a device and contract out manufacturing, both you and the contract manufacturer may need to list the device independently. Clarifying who is responsible for listing — especially in complex supply chains — is an important compliance step.
Listing Does Not Authorize Marketing
A common misconception is that listing a device with FDA means the device is cleared or approved. It does not. Device listing is a registration obligation — it records what you make. Whether you can legally market a device depends on its classification and whether the required premarket review has been completed. A Class II non-exempt device that is listed but lacks 510(k) clearance is illegally marketed, regardless of the listing record. Device listing and premarket authorization are parallel, independent obligations.
Consequences of Non-Compliance
Failure to list or failure to update a listing on time makes the device misbranded under the FD&C Act. FDA can refuse entry of devices from establishments that are not properly registered and listed, and can take enforcement action including warning letters and injunctions for persistent failures. Import alerts can block shipments of devices from foreign establishments with listing deficiencies.
Need Help with Device Registration and Listing?
ADB manages FDA registration and device listing submissions for both domestic and foreign manufacturers, including product code selection, FURLS filing, and annual renewal.
See Registration Service Book a Free ConsultFrequently Asked Questions
What is a product code and how is it assigned?
An FDA product code is a three-letter identifier that classifies a device by type, intended use, and regulatory class. Product codes are defined in the FDA Product Classification database and are linked to 21 CFR regulation sections. When you list a device in FURLS, you select the product code that best matches your device's intended use. The product code determines which premarket pathway and performance standards apply to your device.
When must I update my device listing?
Device listing must be updated within 30 days of any of the following events: introducing a new device into commercial distribution, discontinuing distribution of a listed device, or making a change to a device's intended use, trade name, or design that affects the product code assignment. Updates are submitted through FURLS (FDA Unified Registration and Listing System). Annual renewal of the listing is required between October 1 and December 31 each year, even if no changes occurred.
What information is required in a device listing?
A device listing submission requires: the proprietary (trade) name of the device, the product code, a brief device description, the premarket submission number (510(k), PMA, De Novo, or HDE) if the device is subject to premarket notification, the UDI device identifier if applicable, and the registration number of the establishment where the device is manufactured. Contract manufacturers or specification developers may each have separate listing obligations.
Are all device listings subject to premarket review?
No. Listing a device does not by itself authorize marketing. Class I devices that are exempt from premarket notification, and certain Class II exempt devices, may be listed and marketed without a 510(k). Non-exempt Class II devices must have 510(k) clearance, and Class III devices require PMA approval before commercial distribution. The listing is a registration requirement — the premarket pathway is determined by the device's classification.