FDA Facility Registration vs Product Listing

United States · FDA food, drug, device and cosmetic records · Reviewed 24 August 2026

Jurisdiction🇺🇸United StatesFederal scope

Two different records, four different regimes

Before working out which record you need, it helps to see how differently the same two words behave depending on what you sell.

Which record applies to your product

Food, including dietary supplements

The duty follows the activity. Domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the United States must register, unless an exemption applies — farms, retail food establishments, restaurants and private residences among them. “Facility” means any factory, warehouse or establishment doing those things, so it follows what you physically do rather than whose brand is on the packet. A covered facility must register before it begins manufacturing, processing, packing or holding food. FDA: food-facility registration.

Renewal runs from 1 October to 31 December of each even-numbered year. A registration not renewed in that window is treated as expired and removed from the account. Note also that updating a registration and renewing it are different functions in FDA’s system — during the renewal window the update option is not even available until the renewal is done.

Separate food programs can require product-specific submissions — for example, process filings for certain low-acid canned foods, infant-formula notifications or new-dietary-ingredient notifications. Those are different from general food-facility registration.

Two practical points. FDA charges no fee for registration or renewal. And every registration must carry a unique facility identifier; FDA currently recognises DUNS as an acceptable identifier and checks the associated address against the registration. A foreign facility must additionally appoint a U.S. agent; a domestic facility does not need one. FDA: registration fees and private registration businesses; FDA: food-facility identifiers and agents.

Drugs, including OTC

This regime has the most moving parts. Under section 510 of the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 207, drug manufacturers register their establishments, and registrants list each drug manufactured for commercial distribution. In practice it is three submissions: the establishment registration, the labeler code form, and the product listing.

The timings are specific. Establishments must register within five days of beginning operations, and initial drug listings should follow within three days after that registration. Registration then renews annually between 1 October and 31 December. A submission received inside that window carries the registration through 31 December of the following year; one received outside it does not extend the expiry beyond the current calendar year. Miss the window and the registration is expired on 1 January. FDA: current drug-establishment registration; FDA: how to list a drug.

Listing has two separate obligations that are easy to conflate:

• Updates are due twice each year, in June and December, when listing information has changed.
• Certification that listing information is current is due annually, between 1 October and 31 December. A single blanket “no changes” certification covers products needing no updates, and any NDC that already received a new or updated listing during the calendar year does not need certifying again.

Failure to update or certify may result in FDA removing the product from the NDC Directory. FDA: annual drug-listing certification.

An NDC is a three-segment drug identifier. FDA assigns the labeler code; the firm assigns the product and package codes and submits the complete NDC with the listing. An NDC identifies the listed drug and package, but does not show that FDA approved the drug or verified the submitted information.

Medical devices

Owners or operators of establishments involved in the production and distribution of devices intended for use in the United States register annually, and annual registration runs from 1 October to 31 December for each fiscal year. Device listing is a separate obligation from establishment registration.

What distinguishes this regime is how sharply the duty is role-based. FDA publishes a chart of who must register, who must list and who must pay, and the answers genuinely differ: manufacturers, specification developers, repackagers and relabelers, contract manufacturers and initial importers are inside the requirement, while a domestic distributor that does not import devices is not required to register, list or pay the fee at all. Some roles register without listing. Establishing your role is the whole exercise. FDA: who must register and list.

Registration and listing sit entirely apart from the premarket pathways — 510(k), De Novo, premarket approval, exemption or authorization. A device can be registered and listed and still be unlawfully marketed if its applicable premarket pathway was not satisfied. The two questions are separate, and answering one does not answer the other.

Cosmetics

Cosmetic product manufacturers and processors register their facilities. Separately, the Responsible Person — the manufacturer, packer or distributor whose name appears on the label — lists each marketed cosmetic product, including its ingredients. Those can be different companies, so a brand can owe a listing while owing no facility registration.

The cadences differ within the same regime: facility registration renews every two years, while product listing is updated annually. Registration content must also be updated within 60 days of a change. FDA uses the FDA Establishment Identifier for the facility record and assigns a cosmetic product listing number for the product record. A single listing submission can cover multiple products with identical formulations, or ones differing only in colour, fragrance, flavour or quantity of contents. FDA: MoCRA cosmetic registration and listing.

There is a statutory small-business exemption for responsible persons and facility owners below a threshold of average gross annual United States cosmetic sales over the previous three years, adjusted for inflation. It disappears entirely — whatever the revenue — for products that regularly contact the mucous membrane of the eye, products that are injected, products intended for internal use, and products intended to alter appearance for more than 24 hours where removal by the consumer is not customary. FDA requires no filing to claim the exemption.

One more boundary worth knowing: a cosmetic that is also a drug falls under a statutory overlap exemption and is not subject to cosmetic product listing. That attaches product by product and facility by facility, so a company making both medicated and ordinary cosmetics can sit in both regimes at once.

The category matrix

What record do I actually need?

1. Fix the category by intended use, not by shelf placement. A moisturiser is a cosmetic; a moisturiser sold to prevent sunburn is a drug. A supplement is food. A device is not a drug. Every answer below changes with this one.
2. Establish what you physically do. Do you manufacture, process, pack, hold, import, repack, relabel, or simply resell finished units? Every one of these regimes assigns duties by activity and role, not by whose brand is on the label.
3. Ask whether a facility duty attaches to you at all. If you do not manufacture, process, pack or hold, a facility-registration duty may not attach — and registering something you do not operate produces a record that matches nothing.
4. Ask separately whether a listing duty attaches. General food-facility registration does not create a per-product listing, but separate food programs can require product-specific submissions. Drug, device and cosmetic listing duties depend on the governing regime and the party’s role.
5. Check whether the record already exists. If your manufacturer is already registered and the product already listed, the task is obtaining evidence of that, not creating a duplicate.
6. Work out which clock you are on and whether you have missed it. The four calendars differ, and a lapsed record may require a new submission rather than a simple renewal.
7. Only then decide whether to pay anyone. See the last section.

What each record proves — and what it does not

These records show that registration or listing information was submitted to the applicable FDA system. They do not by themselves show that FDA inspected the facility, verified the information, agreed with the product classification, or approved the product’s safety, effectiveness or lawful marketing.

Three words worth keeping apart. A device is cleared through a 510(k) order, which finds it substantially equivalent to a predicate. A device is approved through premarket approval, a heavier review. A facility or product is registered or listed, which is an administrative filing and neither of the other two. Marketing that blurs these is a recurring enforcement theme, and a service that sells you a “certificate of FDA registration” is selling a document FDA does not issue.

What you can produce is the record itself — a confirmation from the relevant FDA system, or the facility’s entry in it. If you need to turn that into evidence someone else will accept, that is a separate exercise: what FDA registration proof actually looks like walks through it for shelf-stable food.

Renewal clocks, side by side

Common mistakes and their consequences

• Treating registration as approval. It is the most common claim in this space and the one FDA rebuts most directly.
• Chasing an NDC for a non-drug. Supplements are food. Devices are devices. FDA says NDCs should not be assigned to products like these.
• Assuming one filing covers the company. Registration is facility-based in food and cosmetics, establishment-based in drugs and devices, and listing is per product where it exists at all.
• Registering a facility you do not operate. A reseller who registers a warehouse belonging to someone else creates a record that corresponds to nothing.
• Confusing updating with renewing. They are different functions in FDA’s systems, and doing one does not accomplish the other.
• Assuming a lapsed record can simply be renewed. Depending on the regime and how long it has been, a new submission may be required instead.
• Buying a “certificate.” FDA does not issue registration certificates. A private company’s certificate is a private document, whatever it looks like.
• Mixing up cleared, approved and registered. Three different things, none interchangeable.

Doing it yourself versus paying someone

Two facts should frame this decision. FDA charges no fee for food facility registration or renewal. And FDA has stated that firms offering to register facilities on your behalf are not affiliated with it, that it has not contracted with any such firm, and that it does not require anyone to hire help to complete an online registration.

That does not make paid help irrational. A foreign facility with no United States presence genuinely needs a U.S. agent. A supply chain with layered contract manufacturing, several warehouses and a mixed own-brand and resale catalogue can make the role analysis genuinely hard. Recovering access to an account that nobody at the company can log into is a real service. What you are buying in each case is someone’s time and judgement — not a government document, and not a faster decision from FDA.

If you want to compare the scope of paid assistance with the free FDA route, see FDA registration services compared. It is an editorial comparison, not a substitute for deciding which filing duty applies.

Frequently asked questions

For the identifier-level comparison, see NDC vs CPLN vs FURLS.