New FDA Draft Guidance Explains 510(k) Clearance Transfers

The FDA has released a draft guidance document concerning how to notify the Agency when transferring a 510(k) clearance. Titled 'Transfer of a Premarket Notification (510(k) Clearance – Questions and Answers,' the document covers a number of important points that we at ICON often encounter when fielding questions from medical device companies seeking a 510(k) transfer.

The medical device industry is a hotbed of acquisition, which can sometimes mean that organizations are purchased solely for the rights to the products that they currently have on the market. In these cases - or when one company simply wishes to sell its rights to a product to another - the FDA has established a system that obviates the need to obtain a second 510(k) clearance. Since 2007, the Agency has established a database (FDA Unified Registration and Listing System, or FURLS) designed to track the historical ownership of any 510(k) throughout its existence.

In order to facilitate this tracking (which was made more challenging by several quirks in the 510(k) reporting system) the FDA amended its clearance-specific requirements in 2012 to include the premarket submission number for each product in each medical device listing. A key part of keeping the database up to date is the requirement to notify the FDA should a 510(k) clearance change hands. This is done by updating the Device Registration and Listing Module in FURLS within 30 days of the transaction, and it must occur even if a product has yet to actually go on sale.

Since dual ownership of a 510(k) is not allowed, by updating the submission number on a yearly basis the FDA is able to keep track of who owns what medical device. In the case of a conflict of owners - i.e., two holders claiming the same 510(k) in the database - the FDA will intervene and contact both organizations in order to resolve the issue. The system also makes it easier for organizations themselves to track 510(k) ownership, thanks to the database being made available in searchable online form by the Agency.

0 2008-01-18T13:10:54 Administrator


  • Medical Device