Hardware Podcasts

Comparing FDA’s Breakthrough Devices Program & Safer Technologies Program

Global Medical Device Podcast · 11 May 2021 · 41m · Episode 203

What this episode covers

Isabella Schmitt, Director of Regulatory Affairs at Proxima Clinical Research, explains the differences between the FDA’s Breakthrough Devices Program (BDP) and the Safer Technologies Program (STeP). She details how BDP targets life-threatening conditions with potential for improved efficacy, while STeP focuses on safety benefits for less serious conditions. Schmitt highlights the strategic importance of the indication statement in determining eligibility and warns that these designations can raise the FDA's scrutiny bar for clearance.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Greenlight Guru, FDA, CMS

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