Written and maintained by CASRAI Editorial Board
Last updated
General regulatory information, not legal or medical advice. Checked against FDA and eCFR pages on 2026-11-01.
Short answer
Private label medical supplies are products made by one company and sold under another company’s brand. Under FDA’s registration rules, the brand owner is not automatically exempt: a company that writes the specifications for a device sold under its own name is a “specification developer” that must register, list and pay the fee, even if it performs no manufacturing. The label must also say how the named company relates to the device.
Definition and scope
In private label supply, a brand owner sells a product under its own name that another establishment manufactures. The same arrangement is described by several trade phrases: white label medical supplies, medical device private label, and OEM medical supplies private label. For the commercial differences between those three models, see the private label vs white label vs OEM comparison. This page covers a narrower question that the commercial descriptions rarely answer: which party counts as what under the FDA’s own rules, and what the label has to reveal.
The trade terms are not FDA categories. FDA’s registration page does not contain a separate private label note, so the role map below uses the roles FDA actually names.
How it works in practice: who is who under FDA
FDA’s “Who Must Register, List and Pay the Fee” page sorts establishments by what they do, not by what the commercial arrangement is called. Mapped onto a private label arrangement, the roles line up as follows.
| Role | FDA’s description | Register, list, pay fee |
|---|---|---|
| Brand owner that writes the specifications | Specification developer: “Develops specifications for a device that is distributed under the establishment’s own name but performs no manufacturing.” | Yes (21 CFR 807.20(a)(1)) |
| The factory that makes it | Contract manufacturer: “Manufactures a finished device to another establishment’s specifications.” | Yes (807.20(a)(2); foreign establishments 807.40(a)) |
| Company that changes labeling or repackages | Relabeler or repackager. Repackager: “Packages finished devices from bulk or repackages devices made by a manufacturer into different containers.” | Yes (807.20(a)(3)) |
| Domestic distributor or wholesale distributor that is not the manufacturer or importer | Distributes devices without making or importing them. | No (807.20(c)(3)) |
Two details matter for private label. First, FDA states that the relabeler category “does not include establishments that do not change the original labeling but merely add their own name.” Second, 21 CFR 807.3 defines an establishment as “a place of business under one management at one general physical location” where a device is made, assembled or otherwise processed, and defines a wholesale distributor as a person other than the manufacturer or initial importer who distributes a device. An importer is the U.S. owner, consignee or recipient of a foreign establishment’s device. For the wholesale role in more depth, see the guide to the medical supply wholesaler.
What the label has to say
21 CFR 801.1(a) requires the label of a device in package form to “specify conspicuously the name and place of business of the manufacturer, packer, or distributor.” Paragraph (c) is the one private label products run into: “Where a device is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such device; such as, ‘Manufactured for ___’, ‘Distributed by ___’, or any other wording that expresses the facts.” Paragraph (b) adds that a corporation’s name on the label is its actual corporate name, which may be preceded or followed by a division name.
So a brand name alone is not the label statement. The text that identifies the company must carry the qualifier when that company did not make the device. An imported product also raises a separate origin-marking question, covered in country of origin marking for imported medical devices.
Where it matters for supply decisions: questions the role map raises
These are questions, not rules. Each follows from a source above, and none is a requirement that a regulation imposes on a buyer.
- Which role does each party hold? Under FDA’s page, the brand owner, the factory and any relabeler can each be separate establishments with their own registration and listing status.
- Does the brand owner write the specifications? If yes, FDA’s page places it in the specification-developer role, which registers and lists.
- Does anyone change the labeling or repackage? If yes, the relabeler or repackager role applies. Adding only a name to unchanged labeling does not make a relabeler, per FDA.
- What does the label say about the company’s connection? Compare the wording against 801.1(c): “Manufactured for”, “Distributed by” or equivalent.
- Is the product imported? The importer and origin-marking questions then apply; see the origin-marking guide linked above.
When the arrangement involves territory or exclusivity between brand owner and distributor, the contract side is covered in the distributor agreement guide.
Common misunderstandings
“A private label brand is only a distributor, so it does not register.”
Not if it develops specifications for a device distributed under its own name. FDA lists that as a registration, listing and fee case. A plain domestic distributor that does not make or import the device is the exempt category.
“Putting our name on the box makes us a relabeler.”
FDA says the relabeler category does not include establishments that do not change the original labeling but merely add their own name. Whether other roles apply depends on what else the company does.
“White label and private label are different legal categories.”
The registration page uses roles (specification developer, contract manufacturer, relabeler, distributor), not those trade terms. The commercial difference is explained on the comparison page.
FAQ
What are private label medical supplies?
Products manufactured by one establishment and sold under a different company’s brand. The FDA treats the parties by role, such as specification developer or contract manufacturer, not by the trade term.
Is white label the same as private label for medical supplies?
The trade terms are used loosely and overlap; FDA’s registration rules apply by role either way. See the comparison page for how the commercial models differ.
Does a medical device private label brand have to register with FDA?
If it develops specifications for a device distributed under its own name, FDA’s page says it must register, list and pay the fee (807.20(a)(1)).
Who is the manufacturer on an OEM private label product?
The establishment that makes the finished device to another’s specifications is the contract manufacturer, which also registers. The label must reveal the connection of the named company if it did not make the device (801.1(c)).
Sources
- FDA, Who Must Register, List and Pay the Fee, checked 2026-11-01.
- eCFR, 21 CFR 801.1, Medical devices; name and place of business of manufacturer, packer or distributor, checked 2026-11-01.
- eCFR, 21 CFR 807.3, Definitions, checked 2026-11-01.
