Zdrowie i gospodarka · 06/01/2021

FDA Announces Safer Technologies Program for Medical Devices to Improve Patient Access

The Food and Drug Administration (FDA) has released a final guidance document outlining a new voluntary program, Safer Technologies Program for Medical Devices (STeP), aimed at enhancing the safety of medical devices and device-led combination products, with the goal of expediting their development, assessment, and review to improve patient access.