The US Food and Drug Administration (FDA) recently released a draft guidance that clarifies the responsibilities of new owners of 510(k) clearances when products are sold or transferred to another entity.
The guidance, which was issued in a question-and-answer format, also addresses when a new 510(k) is required. Companies are only required to submit a 510(k) if the device is about to be “significantly changed or modified in design, components, method of manufacture, or intended use.”
The guidance states that when a 510(k) clearance for a specific device is sold or transferred from one person to another, the new 510(k) holder must list their device in the FDA Unified Registration and Listing System (FURLS)/ Device Registration and Listing Module (DRLM), within 30 days of the transfer…
