Direct comparison
Supplier vs Distributor in Medical Supply
Supplier vs distributor for US medical devices: 21 CFR 807 defines 'wholesale distributor', not 'supplier'. See which activities change FDA status.
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How do Supplier (or vendor), Wholesale distributor compare side by side?
The table below compares Supplier (or vendor), Wholesale distributor across 10 procurement-relevant dimensions, from kind of term through source.
Side-by-side comparison
| Dimension | Supplier (or vendor) | Wholesale distributor |
|---|---|---|
| Kind of term | Everyday commercial word for a party that sells to you. 'Vendor' is used the same way. | Defined regulatory term in 21 CFR 807.3(t) (US medical devices). |
| Defined in 21 CFR 807.3? | No. Neither 'supplier' nor 'vendor' is defined there. | Yes: 'any person (other than the manufacturer or the initial importer) who distributes a device from the original place of manufacture to the person who makes the final delivery or sale of the device to the ultimate consumer or user.' |
| Position in the chain | Not fixed by the word. The party could be the manufacturer, an initial importer, a distributor or a relabeler. | Between the original place of manufacture and the party that makes the final delivery or sale to the user. The manufacturer and the initial importer are excluded by definition. |
| FDA registration and listing | Depends on what the party actually does (807.20(a)): the rule names developing specifications for a device made by a second party, contract sterilizing, repackaging or relabeling, reprocessing single-use devices, and acting as initial importer. | Under 807.20(c), registration and listing requirements do not apply to a wholesale distributor that does not manufacture, repackage, process or relabel a device. |
| Activities that change its status | The same 807.20(a) activities apply whatever the party calls itself. An initial importer may list by submitting the manufacturer's name and address if it did not develop the specifications or repackage/relabel. | Repackaging, processing or relabeling takes the party outside the 807.20(c) exemption, and importing from a foreign manufacturer makes it an initial importer (807.3(g)), which the definition above excludes. |
| Final delivery to the user | A pharmacy, surgical supply outlet or similar retail establishment making final delivery or sale to the user falls under the exemption in 807.65(e). | The distributor sits before this step: it supplies the party that makes the final delivery or sale. |
| Commercial distribution | 807.3(b): any distribution of a device intended for human use which is held or offered for sale. | The same definition applies to what a wholesale distributor handles. |
| Question the term answers for a buyer | Who is selling to me? The word alone does not say which regulatory role that party holds. | What does this party do with the device between the manufacturer and the final seller? If it only passes the device along, it fits the definition. |
| When to use each term (editorial reading of the rows above) | Use as the general word for whoever sells to you, then work out the role from the activities in 807.20(a). | Use when the party only passes finished devices along and does not repackage, process or relabel them. |
| Source | 21 CFR 807.3, 807.20, 807.65, read at law.cornell.edu on 2026-11-01. | 21 CFR 807.3(t) and 807.20(c), read at law.cornell.edu on 2026-11-01. |
Common questions
Common questions about Supplier (or vendor) vs Wholesale distributor
What is the difference between a supplier and a distributor?
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'Supplier' is a general commercial word that the US device regulations do not define. 'Wholesale distributor' is defined in 21 CFR 807.3(t) as a party, other than the manufacturer or initial importer, that moves a device from the original place of manufacture to the party making the final delivery or sale to the user. A company that repackages, relabels or imports can be a supplier but no longer fits the distributor-only exemption in 807.20(c).
What is the difference between a vendor and a distributor?
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'Vendor' is, like 'supplier', an everyday word for whoever sells to you and is not defined in 21 CFR 807.3. A vendor may be a wholesale distributor, a manufacturer, an initial importer or a relabeler; the regulation turns on the activities performed, not on the label 'vendor'.
