FDA finalizes speedier medical device pathway alternative to breakthrough status

FDA finalizes speedier medical device pathway alternative to breakthrough status

January 6, 2021, MedTech Insight

Scott Danzis is quoted in MedTech Insight regarding the FDA’s final guidance on its new Safer Technologies Program for Medical Devices (STeP) program, which is intended to provide additional support to developers of medical devices that significantly improve on existing products. Mr. Danzis says that STeP is a "welcome complement" to the FDA's Breakthrough Devices Program. “STeP will provide an avenue for more timely interactions and collaboration with FDA reviewers for devices that provide safety improvements, but which do not qualify as breakthrough devices. I would encourage device companies to consider this pathway and discuss it with FDA early in the product development lifecycle,” he adds.