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A ‘STeP’ Backward? Expert Predicts ‘Slow, Quiet Death’ For FDA’s STeP Novel Devices Program

 
• By Shawn M. Schmitt

Former US FDA device center compliance chief Steve Silverman worries that the new Safer Technologies Program, or STeP, has created a three-tiered device-review framework at the agency. But Silverman says his concern “may be a tempest in a teapot” because he suspects STeP might not be long for this world.

A walker over balancing whilst scrambling onto the summit of Todd Crag Loughrigg.
• Source: Alamy

A voluntary program stood up earlier this year by the US Food and Drug Administration to get novel medical devices into the hands of patients faster might not be long for this world, an ex-agency official predicts.

The FDA began accepting applications from interested device makers in March for its Safer Technologies Program (STeP), an initiative that’s modeled on – and is a complement to – the agency’s popular Breakthrough Devices Program

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