FDA Marches Forward With 'STeP' Program To Aid Development Of Significantly Safer Medtech Products

18 Dec 2018

• By Sue Darcey

The US agency is planning to launch another accelerated device approval program along the lines of its successful Breakthrough Devices Program. But this one, the Safer Technology Program (STeP), would focus on devices with enhanced safety features.

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US FDA will use some of the principles and features of its successful Breakthrough Devices Program for a planned Safer Technology Program (STeP) that's designed to hasten the market entry of devices that are determined to be safer than current alternatives.

The program was first described by FDA in April as an outcome of its so-called Medical Device Safety Action Plan....