The specification developer owns the 510(k), not the maker

Five functions, one shared definition of manufacturer

Section 807.20(a) lists who has to register and list as a device establishment, and the list runs wider than a factory floor: a specification developer who initiates or develops the specifications a device is built to; a contract manufacturer or contract sterilizer who makes or sterilizes it for someone else's specifications; an establishment that repackages or relabels it; one that reprocesses a single-use device; and an initial importer bringing a foreign-made device into U.S. commerce. Each function registers on its own, unless a specific exemption applies, and each carries its own annual establishment registration fee independent of whatever the others have already paid on the same device. A single device can carry four or five separate registered establishments behind it before it reaches a customer — the same multiplication this blog has already covered for registration and listing as two distinct duties, extended here across every function that can trigger either one.

The specification developer, not the factory, owns the file

A contract manufacturer builds to someone else's design and doesn't submit its own 510(k) for a device made purely to another firm's specification — that obligation sits with the specification developer, the party whose labeling carries the device's name and whose design choices the submission actually defends against a chosen predicate. A specification developer that never operates a production line can still be the sole 510(k) holder of record, responsible for design control under the quality system regulation and for complaint handling and MDR reporting once the device ships, while the contract manufacturer's own registration covers only the manufacturing operation it performs under contract.

An initial importer's shortcut only reaches so far

An initial importer that neither develops a device's specifications nor repackages or relabels it can satisfy its own listing obligation by naming the actual manufacturer instead of listing the device under its own establishment — a narrower shortcut than distributors sometimes assume, since it applies only to the initial importer, the first link in the U.S. distribution chain, and only when that importer touches nothing about the device beyond moving it across the border. An importer that also relabels the device, even to add a required U.S. label element, has taken on the repackager-relabeler registration duty in its own right and can no longer point to someone else's establishment in its place.

Switching contract manufacturers doesn't touch who owns the submission

Because the specification developer, not the contract manufacturer, holds the 510(k), moving production from one contract manufacturer to another is a registration change for the new and former manufacturing establishments — each has to be listed against the device before it starts producing units for commercial distribution — not a new submission or a transfer of the clearance itself. The same holder keeps defending the same predicate comparison this blog has already covered from the design side. A specification developer that treats a change of contract manufacturer as though it required reopening the 510(k) is solving a problem 807.20's structure was built to avoid.

Where this meets the file

A device master record that only tracks “manufacturer: [company]” collapses functions FDA tracks separately. A registration-and-listing worksheet built around 807.20's roles — specification developer, contract manufacturer or sterilizer, repackager or relabeler, reprocessor, and initial importer, each with its own registration number and listing scope — is previewed in the launch catalog. If your program assigns these roles differently, the shelf takes that correction directly.