510(k) Transfer of Ownership

A 510(k) for a medical device can be thought of as like a patent making a 510(k) transfer of ownership, say following a sale, for example, a particularly important process to follow. The FDA published a draft guidance entitled “Transfer of a Premarket Notification (510(k)) Clearance—Questions and Answers” in December 2014 (See, Docket No. FDA-2014-D-1837). The draft guidance was withdrawn on March 20, 2020 (FDA Withdrawn Guidance).

Although there are no official regulations or guidance on 510(k) transfer of ownership, there are practical considerations from the withdrawn draft guidance that remain prudent to follow.

It’s important to remember that the FDA only allows a 510(k) holder to transfer clearance without a new 510(k) clearance absent a significant modification of the device and there may be only one 510(k) holder at a time. 

Notice of a 510(k) transfer of ownership, even before the withdrawn draft guidance, is accomplished via compliance with device listing requirements.  The transferor notifies FDA by de-listing the device, and the transferee notifies FDA by newly listing the device.

Under 21 CFR part 807, listing a 510(k) device as a manufacturer, specification developer, repacker/relabeler, single-use device reprocessor, or remanufacturer, signals to FDA that the party executing that listing is the current 510(k) holder for that device, because these entities are responsible for the commercial distribution of the device.

This means that the consent of the transferor is implicit in this process since the party must actively de-list the device. In some cases, this is not a problem but in others the two parties may be hostile, even suing one another.

Regardless of the case, the withdrawn draft guidance recommended a, “… legal instrument such as a contract or will, and/or other documentation of the sequence of historical transfers of the 510(k) clearance, up to and including the current holder” as evidence of ownership.

A sales agreement or other contract should be used to memorialize the transfer of ownership. It could also be something like a court judgment. If it’s a sales agreement then key terms would merit including facilitating a smooth notice and transfer of ownership with FDA.

In summary:

• The transfer of ownership should be reflected in a contract or other legal instrument;
• The contract should include provisions to facilitate the appropriate notifications to FDA;
• The new 510(k) owner should assess the device currently on the market against the 510(k) to determine if any changes require a new 510(k);
• The previous 510(k) owner (the transferor) will need to de-list the device;
• The new 510(k) holder must register as a “manufacturer, specification developer, repacker/relabeler, single-use device reprocessor, or remanufacturer” and list the device.