Guidance Breakdown: Transfer of a Premarket Notification 510(k) Clearance
Transfer tricks and traps—a look inside FDA’s June 2025 draft Q&A on 510(k) ownership changes.
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Mergers, divestitures, and carve-outs move 510(k) clearances around with surprising frequency—and with them, the compliance landmines hidden in 21 CFR 807.
The FDA’s new draft guidance, “Transfer of a Premarket Notification (510(k)) Clearance — Questions & Answers,” issued on June 5th, distills those landmines into a plain-language checklist.
The agency walks through who must file what, when a fresh 510(k) is required, and how label, UDI, and database updates prevent the device from becoming instantly misbranded or adulterated. Think of it as the agency’s first primer on “closing day readiness” for device deals.
Here’s our quick breakdown.
There can be only one 510(k) holder
The draft is explicit: because only one entity introduces a device into interstate commerce, "there can be only one 510(k) holder for a device at a time." What changes hands is the clearance itself, not a duplicate number. Everyone else—contract manufacturers, sterilizers, repackagers, relabelers, even initial importers—must list under that single number or, for importers, cite the manufacturer's name and address instead.
Now, there is an initial importer exception: Initial importers have a special option. They can fulfill listing obligations by submitting the manufacturer's name and address instead of the 510(k) number, but only if they didn't initiate device specifications and don't repackage or relabel the device.
Our takeaway: Trace every party touching the product and be sure they know which 510(k) number to cite on day one.
Do you need a new 510(k) after the sale?
If the device you bought is "not significantly changed or modified in design, components, method of manufacture, or intended use," the answer is no—you keep using the original clearance.
But the minute you plan a design tweak, software update, or process shift that triggers FDA's "when-to-submit" tests, you—or your specification developer—must file a new 510(k). Note that certain entities like remanufacturers and reprocessors of single-use devices will need their own 510(k)s regardless.
We suggest firms fold an FDA "significant-change" screen into their post-acquisition engineering roadmap before the first ECO is logged.
The 30-day clock for registration and listing
A buyer that now “engages in an operation” listed in §807.20(a) must:
Register the establishment in FURLS/DRLM within 30 days, and
List every newly acquired device, citing the original 510(k) number.
Previous holder obligations
The selling company must update their device listings when they cease activities on the device and discontinue device listings entirely when they stop commercial distribution.
Annual reporting
New holders must report newly acquired devices during the annual reporting cycle (October 1 - December 31) for any devices not previously reported.
Keep in mind that the FDA leans on FURLS to push rapid recall notices. Missing the deadline automatically makes the device misbranded!
We recommend treating FURLS registration like a closing deliverable. No listing, no shipping.
Label and UDI must change hands, too!
The label must show the new manufacturer, packer, or distributor's name and place of business. Any entity meeting FDA's definition of a labeler must update GUDID when that name changes and ensure the UDI actually appears on the product before distribution.
You may want to include slot label artwork updates and GUDID edits in the same sprint as the ERP rebranding. Import hold-ups are expensive!
Contract players and outsourced operations
Everyone "required to list"—contract manufacturers, sterilizers, repackagers, relabelers—must use your 510(k) number. The holder remains accountable for FD&C Act compliance across the chain.
Initial importers can, instead, list the manufacturer's name and address, but they still face their own registration duties.
We'd suggest sending controlled letters instructing every supplier exactly how to list, and file copies in your Device Master File.
FDA's limited role in transfers
FDA explicitly states it will not update registration or listing information in response to transfer notifications. It's entirely the new owner's responsibility to ensure compliance.
New owners can obtain 510(k) copies through FOIA requests, the public 510(k) database, or directly from prior owners during due diligence.
Enforcement hook—misbranding and adulteration
Skip any of the above—registration, listing, GUDID, or required marketing submissions—and FDA can deem the device misbranded or adulterated under §§501 & 502.
That invites 483 observations, import detentions, and recall pressure, often within weeks of a deal closing, when resources are thinnest.
A few action items we recommend
Here are detailed steps we recommend teams consider to operationalize this guidance:
Pre-sale diligence — Map every intended change against the FDA's significant-change guidances. Create a matrix comparing current device specs to planned modifications, flagging any that could trigger new 510(k) requirements before LOI signing.