Medical device manufacturers might be surprised to know that the maintenance of the 510(k) status of a particular product does not always pass through the FDA. In fact, it is possible to transfer 510(k) ownership from one entity to another without having to involve the federal regulator, avoiding the need to re-submit a medical device for approval in the event that ownership of a company or its intellectual property changes hands.
How does a 510(k) transfer work? It’s a simple process, but it requires that each side ensure that all documentation regarding the medical device in question is transferred to the new owner, and that the device is properly listed according to CFR part 807. The purchase agreement itself must include, in writing, any changes that have been made to the device since its first 510(k) submission, the official description of the product from the initial approval letter, the rights to use the medical device’s 510(k) number, and certification that the 510(k) clearance is current and legal.
To make sure that one is fully covered from a legal perspective during the purchase, it’s also a good idea to bundle all official 510(k) documentation available from the FDA with the internal records of the seller. This includes correspondence relating to the approval process, as well as the Device Master Record. Finally, a post-transfer design review will need to be added to the product’s Design History File by the purchaser. All of this information should be included with an imported medical device when accessing the U.S. market from outside of the country, in order to avoid potential regulatory snags.
The FDA itself does not participate in 510(k) transfers, but medical device companies must properly de-list and then re-list a product once the transfer has occurred. This is because only one company may sell a product under a single medical device clearance number at a time (the new owner can re-list using form FD-2892). Any licensed manufacturing of a transferred device must be accomplished under a new 510(k) clearance. Once the re-listing has been accomplished, the transfer can be considered complete.
Given the absence of federal oversight of this particular process, it’s important to make sure to rigorously certify that each of the above steps has been followed to the letter. This reduces the chances that a medical device will be manufactured by more than one firm under the same clearance number – a scenario that could require the new owner to apply for a fresh 510(k).