The U.S. Food and Drug Administration (FDA) has proposed the Safer Technologies Program (STeP), a new pathway to expedite approval of medical devices, treatments, or diagnostic tools that improve upon the safety of existing products on the market.
STeP was modeled after the Breakthrough Devices Program, but it focuses on less severe conditions for which new products can reduce known risks like serious adverse events, device failures, use-related hazards, or user errors. The new program will include priority review and interactive, timely communications with the FDA during the development process. It will cover devices and device-led combination products subject to review under a premarket approval application, premarket notification (510(k)) clearance reviews, or de novo classification request.
“This new approach may also drive greater market competition to develop safer, more effective devices by providing the opportunity to demonstrate superior performance to the FDA-established benchmarks,” FDA device center director Jeff Shuren, MD, said.