Device Listing Numbers and Product Codes Under 21 CFR 807.28

1. Key takeaways

Device Listing is established under 21 CFR Part 807, and its numbering rules are set out in 21 CFR 807.28(f): all devices under a 510(k)-exempt product code share a single listing number, while non-exempt devices receive one listing number for each FDA premarket submission number. In addition, all devices of a foreign establishment must be listed before the device is imported or offered for import into the United States. These two features together determine both the shape of a company’s listing ledger and the point in the supply chain at which listing must already be in place.

• Listing numbers under an exempt product code: one shared listing number for all devices under that code, under 21 CFR 807.28(f).
• Listing numbers for non-exempt devices: one listing number per FDA premarket submission number, under the same provision.
• Foreign establishments: listing of all devices must be submitted before import or offering for import, under 21 CFR 807.28(c).
• Cessation of commercial distribution requires terminating the listing; resumption requires reactivating it, under 21 CFR 807.28(d) and (e).

2. Legal basis

The listing regime is anchored in four provisions of 21 CFR 807.28, which respectively fix the timing for foreign establishments, the numbering rules, and the actions required when commercial distribution stops and restarts. The current text was adopted in the 2012 revision of Part 807.

3. Expert insights

Insight 1: The listing number assignment rules directly shape the structure of the listing ledger.

Under 21 CFR 807.28(f), all devices under a 510(k)-exempt product code share one listing number, while non-exempt devices receive one listing number for each FDA premarket submission number. The consequence for record keeping is immediate. A product line cleared through 510(k) that holds three K numbers will carry three listing numbers, one per submission, and each must be tracked individually. An exempt product line, by contrast, keeps a single listing number no matter how many models or specifications it contains. Companies that assume a one-to-one mapping between models and listing numbers will either over-report or under-report their listings, so the ledger must be designed around product codes and their exemption status rather than around the product catalog alone.

Insight 2: For foreign establishments, the listing deadline falls before the goods are shipped.

Under 21 CFR 807.28(c), the listing of all devices of a foreign establishment must be submitted before the device is imported or offered for import into the United States. This provision ties the listing obligation to the moment of shipment rather than the moment of sale. A foreign manufacturer that completes listing only once products have entered its United States distribution channel has already missed the regulatory point of reference. In practice, this means the listing activity belongs to the export preparation phase, alongside pricing, labeling, and logistics, and the first shipment of any new product line should be gated by a completed listing confirmation.

Insight 3: Both stopping and resuming distribution are statutory actions, not passive events.

Under 21 CFR 807.28(d), the owner or operator of an establishment that ceases commercial distribution of a device must terminate the listing using FDA’s electronic device registration and listing system. Under 807.28(e), when distribution resumes, the previously terminated listing must be reactivated, and the listing information must be updated at the same time, for example where there is a new establishment, a new activity, or a new proprietary name. A product withdrawal or relaunch therefore has a defined regulatory footprint: termination on the way out, reactivation and information updates on the way back in. Leaving a discontinued product’s listing untouched, or relaunching without reactivating, both depart from the codified process.

Insight 4: A listing is considered terminated only when all devices under its key have stopped.

Under 21 CFR 807.28(d), a listing is deemed terminated when either of two conditions is met: all devices under a 510(k)-exempt product code have ceased to be distributed, or all devices under an FDA premarket submission number have ceased to be distributed. This means that discontinuing a single model does not terminate the listing. The termination decision must be made at the level of the product code or the submission number, not at the level of the individual item. A company should therefore record, for each discontinued model, which product code and which submission number it belongs to, and evaluate whether the remaining devices under that key are still being distributed.

4. Practical recommendations

The following practices align a company’s listing ledger and lifecycle processes with the rules in 21 CFR 807.28.

• Build the listing ledger in four layers, from product name to product code to listing number, and annotate the exemption status of every product code.
• For foreign establishments, complete the listing of all devices before the first shipment, and do not defer the work to the sales stage.
• When a model is discontinued, first determine whether the discontinuation amounts to all devices under the product code or submission number having stopped, and only then decide whether to terminate the listing.
• When distribution resumes, reactivate the listing and update the information in the same step, covering a new establishment, a new activity, or a new proprietary name.
• During the annual update period, reconcile the listing ledger line by line against the products actually on sale.

5. Verification checklist

Use the following items to confirm that listing numbers, timing, and lifecycle actions all conform to 21 CFR 807.28.

• □ Product code determination has been completed, and the 510(k) exemption status of every code has been annotated.
• □ The listing number structure conforms to 21 CFR 807.28(f).
• □ For the foreign establishment, listing was completed before the first import.
• □ The discontinuation process includes a determination of whether all devices under the key have stopped.
• □ The resumption process includes reactivation of the listing and updating of the listing information.
• □ During the annual update period, the listing ledger has been reconciled against the on-sale product list.

Regulatory information verified as of October 28, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, US Agent and local testing support for the United States market. Our team manages FDA establishment registration and listing, 510(k)/De Novo/PMA submissions, and supports post-market reporting obligations. Business enquiries: info@grzanglobal.com