FDA Wants You to Take a STeP in the Right Direction

Recently, the FDA has taken 2 major steps to encourage innovation in medical devices. The first is finalizing guidance on the Breakthrough Device Program, which will enable accelerated approval of innovative medical devices that more effectively diagnose or treat life-threatening or irreversibly debilitating conditions.

Regulatory ComplianceNaveen AgarwalJanuary 7, 2019patient safety, FDA, STeP, STeP Program FDA, Medical Device SafetyComment