FDA Registration and Clearance for Online Businesses

By Paul S. Rafelson, Founder, Rafelson Law PLLC

Why are registration, listing and clearance different questions?

Many businesses use “FDA approved” or “FDA registered” as if they meant one thing. They do not. Registration is generally about a place and a person: an establishment that makes, processes, packs, holds or otherwise handles a regulated product tells FDA that it exists. Listing is about the product itself and is generally filed with, or after, registration. Clearance, for a medical device, is FDA’s determination, through the 510(k) pathway, that a device is substantially equivalent to a device already legally on the market. Each has its own rules, its own timing and its own consequences for what the seller may say on a listing, and a statement that fits one can mislead about another.

That is the reason a single label such as “FDA registered” deserves care. Registration does not make a product a device (21 C.F.R. § 807.20(b)). It also does not mean FDA approved the facility or the product. FDA treats any suggestion of approval based on registration as misbranding (21 C.F.R. § 807.39).

Why does the product category come first?

FDA regulates food, drugs, cosmetics and medical devices under different parts of the Federal Food, Drug, and Cosmetic Act, and the duties differ. Which category a product falls into generally turns on its intended use, and a seller’s own claims, labeling and advertising can be evidence of that intended use. A product sold as a soap, a supplement, a skin cream or a wellness gadget can land in different categories depending on the words used to sell it. That is also why the same product can raise a different question on a different marketplace listing.

Why does it matter what the seller actually does?

The registration rules are written around activities. For devices, the regulation lists manufacturers, specification developers, repackagers and relabelers, reprocessors of single-use devices and initial importers, among others, and it excludes a wholesale distributor that does not manufacture, repackage, process or relabel the device (21 C.F.R. § 807.20). An importer may be treated differently from a reseller of goods already in the United States, and a seller that changes the label or the packaging may be treated differently from one that does not. A private-label brand with a contract manufacturer often holds more than one registration role at once, depending on who specifies, who makes, who labels and who ships.

Food facilities have their own registration rule: the owner, operator or agent in charge of a domestic or foreign facility that manufactures, processes, packs or holds food for consumption in the United States is generally required to register, subject to exemptions (21 C.F.R. § 1.225). Cosmetics have a newer regime under the Modernization of Cosmetics Regulation Act. The owner or operator of a facility making or processing cosmetics registers the facility. The responsible person, meaning the manufacturer, packer or distributor named on the label, lists each product. Small-business exemptions exist and carry their own carve-outs. Drug establishments register under 21 U.S.C. § 360. Which of these applies to a brand that outsources production is a fact question, and the answer may differ for the brand and for its manufacturer.

Why does a 510(k) turn on comparison?

A 510(k) is a premarket notification. The device is compared to a legally marketed predicate device, and FDA decides whether the new device is substantially equivalent: it has the same intended use as the predicate and either the same technological characteristics or different characteristics that do not raise different questions of safety and effectiveness. The regulation says a notification is generally due at least 90 days before a device is introduced into commercial distribution, and it lists situations that trigger one, including a first introduction by a person required to register and a significant change in design, components, method of manufacture or intended use (21 C.F.R. § 807.81). Some lower-risk devices are exempt, with limits on the exemptions, and some firms, such as many distributors of another firm’s domestically made device, are not the ones who submit. Our article on 510(k) substantial equivalence goes into why the comparison is central.

A cleared device is not the same as an “approved” one, and FDA’s clearance is specific to the device and the intended use that were reviewed. Changing the product or the claims afterward may raise the question again.

Why do marketplaces ask about it?

Amazon and other platforms apply their own category policies, which may ask for documents, registrations or clearance letters before a listing in certain categories is open. Those policies are set by the platform, change over time and are not the same as the law. A listing can be accepted by a platform and still raise a legal problem, and the reverse can happen. Rules for specific categories are best read against the current platform terms and the underlying regulation together.

Why can the words on a listing matter as much as the product?

Claims can move a product across a line. A statement that a product treats, prevents or mitigates a disease can suggest drug or device status, while a statement about appearance or cleansing points toward cosmetic status. Claims also draw attention from regulators, competitors and platforms. This is one reason compliance reviews often look at the listing copy, the packaging, the website and influencer posts together. See our pages on packaging compliance and FTC reviews and claims for how those pieces connect, and compliance with laws for the wider picture.

When does it make sense to involve a lawyer?

Before launch. The facts deciding the outcome are the product, your role, where it is made and what it claims. Those are easy to shape before a listing goes up and hard to change after a removal or a letter. We read the rule against your facts, tell you where the answer is clear and tell you when you need a regulatory consultant or a lab instead of a lawyer.

How do I get started?

Contact us. Tell us the product, what you do with it, where it is made and what the listing says, and we will tell you whether we can help.

Frequently asked questions

Related pages

Sources and notes

• 21 C.F.R. § 807.20 (who must register, device establishments), § 807.39 (registration is not approval) and § 807.81 (when a premarket notification is required), eCFR.
• 21 U.S.C. § 360 (registration of producers, listing, premarket notification under § 360(k), exemptions under § 360(l) and (m)).
• 21 C.F.R. § 1.225 (food facility registration).
• FDA, Premarket Notification 510(k) page (substantial equivalence, who submits, who does not).
• FD&C Act §§ 604(4) and 607, as added by the Modernization of Cosmetics Regulation Act of 2022 (responsible person, facility registration and product listing).