Safety and Performance Based 510(k)

The Safety and Performance Based Pathway is generally preferred for well-understood medical devices choosing Abbreviated 510(k) as the clearance pathway. The FDA expects to operationalize this pathway once the first device types and applicable performance criteria have been identified and final guidance has been published.

The main advantage is that, once this pathway is operational is that medical device manufacturers will have the option to meet FDA-identified performance criteria to demonstrate that its device is as safe and effective as a predicate device.


What device types are appropriate for the Safety and Performance Pathway? Is there any difference in the content of a Safety and Performance-Based 510(k) and the traditional/ abbreviated 510(k)?