Why Picking a Predicate Can Make or Break Your 510(k) | Device & Conquer | S2:E4

About this episode

This episode discusses the critical importance of selecting a predicate device for 510(k) submissions in the FDA clearance process.

Choosing a predicate device can make—or break—your 510(k) submission, so it's important to choose wisely. In this episode of Device and Conquer , Michelle Lott and Ti Benson break down one of the trickiest parts of the FDA clearance process: how to select a predicate that passes the “substantial equivalence” test without raising new questions of safety and efficacy. You’ll learn how to build a strong predicate comparison table, what features FDA expects you to include, how to evaluate post-market data, and when older or newer devices make sense. Michelle and Ty also unpack the latest FDA thinking on predicate age, recalls, and draft guidances that are reshaping the regulatory landscape. Whether you’re new to regulatory strategy or refining your next submission, this conversation offers practical insight—and a few laughs along the way—into making your predicate selection bulletproof. Watch the video on YouTube: Be sure to subscribe to the Device & Conquer podcast for bold, insightful conversations that make medtech regulation make sense. Visit us at https://leanraqa.com/ for even more regulatory goodness and to learn more about our services. 📩Got a question or a topic for a…

People in this episode

Host: Michelle Lott

Guest: Ti Benson

Topics covered

• predicate device selection
• 510(k) submission
• FDA clearance process
• regulatory strategy
• medical devices

Keywords

• predicate device
• 510(k)
• FDA
• regulatory affairs
• medical devices
• substantial equivalence
• post-market data
• device recalls
• guidances

Mentioned in this episode

Organizations: FDA, Device & Conquer, leanraqa.com

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