US FDA Introduces Safer Technologies Program (STeP) for Certain Medical Devices and Device-led Combination Products
The FDA has introduced “Safer Technologies Program for Medical Devices (STeP)” in line with the “Breakthrough Devices Program”, to facilitate timely access to certain devices and device-led combination products. The existing program is voluntary and applicable for devices aimed to treat and diagnose non-life threatening or reasonably reversible disease conditions, whereas, the Breakthrough Devices Program is intended for devices to be used in life-threatening or irreversibly debilitating disease conditions.