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

Executive Summary

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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