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FDA Takes 'STeP' Forward For Medtech Innovation With Safer Technologies Program Modeled On Agency's Breakthrough Pathway

 
• By Shawn M. Schmitt

People with non-life-threatening and reasonably reversible conditions will soon have access to innovative, early development-stage medical devices and device-led combination products thanks to the US FDA's upcoming Safer Technologies Program (STeP). STeP is modeled on, and is a complement to, the agency's popular Breakthrough Devices Program, an accelerated development pathway for devices that the agency finds could provide a more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

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People with non-life-threatening and reasonably reversible conditions will soon have access to innovative, early development-stage medical devices and device-led combination products thanks to an upcoming program from the US Food and Drug Administration.

The agency announced plans for its new Safer Technologies Program (STeP) on 18 September and released a draft guidance document on the same day that explains how the initiative...

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