Statement From the FDA on Transformative New Steps to Modernize FDA’s 510(k) Program to Advance the Review of Medical Devices

On November 26, 2018, FDA Commissioner Scott Gottlieb, MD, and Director of the Center for Devices and Radiological Health Jeff Shuren, MD,  announced proposed changes intended to modernize the 510(k) clearance pathway to keep pace with the increasing complexity of rapidly evolving technology. The FDA is planning to rename this new approach the “Safety and Performance Based Pathway” to reflect its focus on advancing improved safety and performance of new low-risk to moderate-risk products. It is an alternative pathway to substantial equivalence that will provide more direct evidence of the safety and performance of a device and better information for patients and providers to make well-informed health care decisions. This new approach may also drive greater market competition to develop safer devices.