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Private label manufacturing is commonly described as one company making a product that another company sells under its own brand. For laboratory and medical supplies the useful question is not the brand but the roles: who makes the product, who writes its specifications, and whose name the label shows. In the United States, FDA sorts these roles for medical devices into separate categories with separate registration duties. This guide maps them and lists what to verify. It is general product and regulatory information, not medical or legal advice.
Short answer
In a private label arrangement the brand owner sells a product that a different establishment manufactures. For a medical device, FDA treats a company that makes a finished device to another establishment’s specifications as a contract manufacturer, and a company that develops the specifications for a device sold under its own name, without manufacturing, as a specification developer. Both register with FDA and list their devices. The label must also name the connection: 21 CFR 801.1(c) requires a qualifying phrase such as “Manufactured for” or “Distributed by” when the named company did not make the device.
Definition and scope
The term comes from retail, where a store or brand sells goods made by someone else. It is often grouped with white label and OEM arrangements; the distinctions are laid out in private label vs white label vs OEM in medical products, and the medical-device uses of the OEM label are covered in OEM medical devices.
This page stays on the general arrangement and the responsibility split. Label wording for specific products is covered in private label medical supplies, and the full labeling rule in FDA labeling requirements for medical devices. The FDA and CFR points below apply only to products that meet the legal definition of a medical device. Other laboratory consumables follow other rules.
How the arrangement works in practice
Two parties are involved at minimum. The brand owner decides what product is sold under its name. The manufacturer makes it. Under 21 CFR 807.3(d), “manufacture” means the making by chemical, physical, biological, or other procedures of any article that meets the device definition, so the establishment that performs that making is the manufacturer, whatever name is printed on the pack.
FDA’s page on who must register describes the specification developer as an establishment that develops specifications for a device distributed under its own name but performs no manufacturing. It also includes establishments that, in addition to developing specifications, arrange for a contract manufacturer to make devices labeled with another establishment’s name. A brand owner that only specifies and sells is therefore not “just a seller” in FDA’s terms. For the contract side of the relationship see contract manufacturing for medical devices.
Who does what: FDA’s role categories
The table restates FDA’s “Who Must Register, List and Pay Fee” page (checked 2026-11-03).
| Role | FDA description | Registers and lists? |
|---|---|---|
| Contract manufacturer | Manufactures a finished device to another establishment’s specifications | Registers, lists, pays fee |
| Specification developer | Develops specifications for a device distributed under its own name but performs no manufacturing | Registers, lists, pays fee |
| Relabeler | Changes the content of the labeling supplied by the original manufacturer | Registers, lists, pays fee |
| Repackager | Packages finished devices from bulk, or repackages them into different containers | Registers, lists, pays fee |
| Initial importer | Imports a device into the United States | Registers and pays fee; does not list |
| Domestic distributor or wholesale distributor that is not a manufacturer or importer | Distributes the device | No registration, listing or fee |
FDA’s page also states that adding only your own name to otherwise unchanged labeling is not relabeling. Whether a given arrangement falls into one category or several is a regulatory question for the parties and their advisers, not something the table settles.
What the label must show
Under 21 CFR 801.1(a), the label of a device in package form must specify conspicuously the name and place of business of the manufacturer, packer, or distributor. Under 801.1(c), where a device is not manufactured by the person whose name appears on the label, that name must be qualified by a phrase that reveals the connection such person has with the device, for example “Manufactured for ___” or “Distributed by ___”, or other wording that expresses the facts (checked 2026-11-03 at Cornell LII). That qualifier is the quickest label check on a private label product: a bare brand name with no connecting phrase deserves a question. Imported goods raise a separate marking question, covered in country of origin marking for imported medical devices.
What to verify before ordering: a checklist
Each item follows from the sources above; none is a ranking of suppliers.
- Who is the manufacturer? Ask the brand owner to name the establishment that makes the device, and compare it with the “Manufactured for” or “Distributed by” wording on the label.
- Is the brand owner a specification developer? If it specifies the device and arranges manufacture, FDA expects it to register and list. Ask how it is registered.
- Is the maker registered? A contract manufacturer of a finished device is expected to register and list; foreign makers fall under 21 CFR 807.40(a) and domestic ones under 807.20(a)(2).
- Is there a relabeler or repackager in the chain? Either one has its own registration duties.
- Is there an importer? An initial importer must register and pay the fee and needs a United States address.
- Does the label use a connecting phrase? Check against 21 CFR 801.1(c).
The search for a maker is covered step by step in how to find a medical supply manufacturer.
Common misunderstandings
“The brand owner is only a reseller.”
Not if it develops the specifications. FDA’s specification developer category exists for exactly that case.
“Putting our name on the pack is relabeling.”
FDA’s page says adding only your own name to unchanged labeling is not relabeling; changing the labeling content is.
“The label name is the manufacturer.”
Not necessarily. The label name may be a distributor or a brand owner, which is why 801.1(c) requires a qualifying phrase.
“These rules cover every lab product.”
The FDA categories above apply to medical devices. Chemicals, general glassware and other non-device items follow different rules.
FAQ
What is private label manufacturing?
It is commonly described as one company making a product that another company sells under its own brand. For medical devices, the maker is a contract manufacturer and the brand owner is usually at least a specification developer under FDA’s categories.
Does a private label brand owner have to register with FDA?
For medical devices, FDA says an establishment that develops specifications for a device distributed under its own name, without manufacturing it, registers and lists. A non-importing domestic distributor that does none of those things does not.
What must the label say on a private label medical device?
The name and place of business of the manufacturer, packer, or distributor, with a phrase such as “Manufactured for” or “Distributed by” when the named company did not make the device (21 CFR 801.1).
Sources
- FDA, Who Must Register, List and Pay the Fee, checked 2026-11-03.
- 21 CFR 801.1, Medical devices; name and place of business of manufacturer, packer or distributor, Cornell LII, checked 2026-11-03.
- 21 CFR 807.3, Definitions, Cornell LII, checked 2026-11-03.
