What You Need to Know About FDA Breakthrough Devices leanRAQA Today S5:E3

Everyone wants that shiny FDA Breakthrough Device designation — but what does it really take to earn it, and does it actually make a difference? In this episode, Michelle Lott joins Monir El Azzouzi on the Medical Device Made Easy podcast to unpack the truth behind the Breakthrough Devices Program — from eligibility and benefits to the myths, statistics, and reality checks every medtech company needs before applying. They discuss how this program — and its sibling, the Safer Technologies Program (STEP) — fits into the FDA’s pre-submission framework, the most common reasons applications are rejected, and why only a fraction of “breakthrough” devices ever make it to market. Here's what else you’ll learn: What the FDA Breakthrough Device Program is — and what it’s not Key differences between Breakthrough and Safer Technologies (STEP) programs How to prove your device treats a life-threatening or permanently debilitating condition Why early data, prototypes, and patient advocacy are essential for success What the real benefits (and limits) of designation are Hard stats: only ~12% of devices reach market authorization How to make your submission persuasive — and avoid the “rose-colored glasses” trap Whether you’re an early-stage startup or an experienced RAQA professional, this conversation demystifies one of FDA’s most talked-about programs — and shows you how to navigate it strategically.

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What You Need to Know About FDA Breakthrough Devices leanRAQA Today S5:E3 is an episode from RA/QA Today by RAQA Today.

This episode is 00:23:03 long.

This episode was published on Jun 16, 2025.

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