Posted by Michael Wonder on 18 Dec 2018
Statement from FDA Commissioner and Director of the Center for Devices and Radiological Health on new steps to promote innovations in medical devices that help advance patient safety
18 December 2018 - Spurring innovation of medical products so that patients can have access to safe, effective treatments that improve or save lives is a fundamental part of our mission.
We’ve taken several steps to enhance how we deliver on this mission through the goals we laid out in our Medical Device Safety Action Plan that the FDA announced earlier this year and through recent updates on our initiatives to modernise and enhance the FDA’s 510(k) and De Novo review processes. Today we’re taking steps on two additional device programs: finalising guidance on our existing Breakthrough Device Program and announcing plans for a new Safer Technologies Program (STeP).
STeP is an idea we first outlined in the April 2018 Medical Device Safety Action Plan, which aims to encourage innovation and market entry of device technologies that are safer than current alternatives.
