A 510(k) may be bought, sold, or transferred. FDA is not involved in transfers of ownership. There is no requirement to notify FDA of change of ownership; nonetheless, upon inspection of the firm or upon entry of the product in the U.S., FDA may request a review of documentation of ownership. We advise our clients that the new owner should maintain information documenting the transfer of ownership of a 510(k), including any legal transactions that took place, in its 510(k) files. The new owner should list the device according to 21 CFR part 807 and the previous owner should delete its device listing. Note that neither a registration nor a listing proves 510(k) ownership.
To avoid problems when importing a device with a transferred 510(k) ownership, FDA recommends that a copy of the specific information relating to the ownership sale or transfer accompany all shipments to the United States. This could be a simple one-page document detailing the transfer transaction.
A buyer of a 510(k) approval must conduct a thorough due diligence review of the 510(k) approval and the device specifications. A few things to keep in mind are:
- Since the decision to file a 510(k) for a device modification is purely of the owner, the buyers are therefore advised to obtain a list of all device modifications and assess whether the decision of the seller not to file a 510(k) application for the modification was reasonable because the FDA may disagree retroactively with a manufacturer’s determination not to seek 510(k) clearance for a modification and require post-clearance 510(k) submission. It is further advised that the buyer obtain a warranty from the seller that the existing 510(k) clearance is legally adequate to market the device.
- Because the FDA does not keep a record of the transfer of ownership, it is important that the buyer obtains a warranty from the seller that the seller owns the 510(k) and has not previously transferred to another party.
- The buyer must review all the records that the seller is legally required to keep regarding the device, including complaint files; reports of adverse events, corrections, and removals; device master records (DMRs); and records of device history and quality systems. The buyers are advised to seek agreement from the seller to transfer all these records and reports to the buyer.
Lack of knowledge of one’s role in the 510(k) submission or improper licensing and transfer of ownership may lead to marketing of a non-approved product in the U.S. and a potential exposure to tough FDA penalties.