FDA Issues Final Guidance on Medical Device Safety and Performance-Based Pathway

The Food and Drug Administration (FDA) recently issued a final guidance document titled, “Safety and Performance Based Pathway” for medical devices. In this guidance, the FDA expands the Abbreviated 510(k) Program for demonstrating substantial equivalence by describing an optional pathway dubbed the Safety and Performance Based Pathway. The guidance states this pathway is for certain, well-understood device types, where a submitter would demonstrate that a new device meets FDA-identified performance criteria to demonstrate that the device is as safe and effective as a legally marketed device.