The US Food and Drug Administration (FDA) has issued a guidance for its new Safer Technologies Program (STeP), which is designed to facilitate patient access to innovative medical therapies. The program is similar to the Breakthrough Devices Program, which was established in December 2018.
To qualify, medical devices and device-led combination products must be expected to “significantly improve the safety of currently available treatments or diagnostics that target an underlying disease or condition associated with morbidities and mortalities less serious than those eligible for the Breakthrough Devices Program.” This could include devices that diagnose or treat non-life-threatening or reasonably reversible conditions.
“The STeP program will provide the opportunity for an expedited approval pathway for many devices that are innovative but may not meet the strict criteria for the Breakthrough Device designation,” said Foundation Chief Scientific Officer, Jessica Foley, PhD. “We encourage any interested companies in the focused ultrasound space to explore how this program could facilitate progress toward commercialization.”