Hardware Podcasts

What is the Safer Technologies Program (STeP) and Can Your Device Use It?

Global Medical Device Podcast · 21 Mar 2021 · 32m · Episode 189

What this episode covers

Mike Drues, President of Vascular Sciences, explains the FDA's Safer Technologies Program (STeP) to host John Spear of Green Light Guru. Drues clarifies that STeP is a voluntary priority review designation, not a marketing pathway, designed for devices that improve safety rather than efficacy, distinguishing it from the Breakthrough Devices Program (BDP). He details eligibility criteria, such as reducing serious adverse events or user errors, and outlines the application mechanics, including the 60-day decision timeline and the mutual exclusivity of STeP and BDP designations.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Vascular Sciences, Green Light Guru
Also
FDA, Breakthrough Devices Program, 510 K, PMA, De Novo, CMS

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