Understand FDA device listing requirements and how to use product codes for compliance. Learn what information to include, who is responsible for listing, how to update listings, and why accurate product codes are essential to avoid regulatory issues and shipment delays.
Alongside registering your establishment, the FDA requires you to list each medical device that you make or import. Device listing creates a catalog of devices in commercial distribution, linked to the registered establishments. Here’s what you need to know about fulfilling the device listing requirements and the role of FDA product codes in that process.
When you list a device with FDA, you provide key identifying details about the product. This typically includes:
The FDA product code is central to device listing. It’s how you inform FDA exactly what type of device you have. Product codes are tied to the device’s classification regulation and risk category. For instance, a blood glucose meter has a specific product code that tells FDA it’s a Class II device requiring a 510(k), whereas a simple manual stethoscope has a different code indicating it’s Class I (often 510(k)-exempt). When listing a device that is exempt from premarket submission, you must supply the product code, so FDA knows the device’s regulatory category. The FURLS listing interface allows you to search FDA’s database for the correct code – you can search by keywords or by reviewing the 21 CFR classification regulations. FDA also provides an online Product Classification database where you can input a device description and find possible codes.
Example: If you make a surgical scalpel, you’d look up its product code (let’s say “GDW” for a general scalpel – hypothetical example). In the listing, you’d enter GDW, which corresponds to 21 CFR 878.xx and indicates a Class I device (exempt from 510(k)). The system might ask you to confirm details and then you’d list it. If you instead make an orthopedic implant that required a 510(k), you’d enter its product code (e.g., “JDI”) and also enter the 510(k) number that was cleared for that implant.
Generally, the device’s manufacturer or specification developer is the primary party responsible for listing the device. In fact, FDA stipulates that a device must be listed by the manufacturer/spec developer (or other primary party) before certain secondary parties can list it[18]. For example, a contract sterilizer can list a device to note they sterilize it, but only after the device is initially listed by its manufacturer. Similarly, a foreign exporter (who exports someone else’s device) can’t list a device until the actual manufacturer has done so. This prevents confusion and ensures there is one “root” listing for each device, with others linking to it.
Initial Importers do not create their own new listings for devices (they reference the manufacturer’s listing as covered earlier). However, they do need to make sure the foreign manufacturer has listed the device. If an importer tries to import a device that the manufacturer neglected to list, that device will flag as unlisted and be a problem at import.
It’s critical that your device listings remain accurate. FDA and customs will use the listing information to verify shipments. For instance, at import, FDA checks the declared product’s description against the listing database. If you’ve listed a “Widget Model X” as a Class I device, but you’re actually shipping an unlisted “Model Y” or a device that doesn’t match the product code, you risk detention.
Whenever something changes with your device, you may need to update the listing:
FDA provides an option to download your own listings for review, and you can also publicly search the Registration & Listing database to see what devices a given company has listed. It’s a good practice to periodically review your listings for accuracy.
Selecting the correct product code is not just an administrative detail – it has compliance implications. The product code determines what regulatory requirements apply. For instance, it ties to whether a 510(k) was required. If you list under the wrong code and indicate your device is exempt when it’s not, you could be marketing a misbranded device (for lack of a required 510(k)). Conversely, over-reporting might cause unnecessary regulatory burden. So do take care to identify the right code. If uncertain, consider using FDA’s 513(g) process (a formal request for classification) or consult an expert.
If your product is a device that contains a drug or biologic component (a combination product), listing gets a bit more complex. FDA requires you to identify it as a combination product and select the type (e.g., “prefilled drug delivery device”) during listing. These products still get a device listing, but you are flagging that there’s another regulated component involved.
In summary, device listing is how you tell FDA “these are the products I am marketing.” Each listing entry should paint a clear picture of the device’s identity and regulatory status. Make sure every device you sell in the U.S. is properly listed before it hits the market (or at least within 30 days of entering the market, per FDA rules). And keep your listings updated as things change. This not only keeps you compliant but also facilitates smooth importation and avoids red flags in FDA’s screening systems.
