Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration

Issue Date: September 20, 2019
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, 510(k)
Status: Final

Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration

This guidance provides FDA’s current thinking on expanding the concept of the Abbreviated 510(k) Program for demonstrating substantial equivalence for premarket notification (510(k)) submissions. The intent of the guidance is to describe an optional pathway – the Safety and Performance Based Pathway – 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.

Download the Guidance Document