How to Build a 510(k) Without Losing Your Mind | Device & Conquer | S2:E3

About this episode

This episode discusses the intricacies of preparing an FDA 510(k) submission and the importance of storytelling in the process.

Building a 510(k) isn’t just about filling in forms — it’s about telling the FDA a story they can’t say no to.In this episode of Device & Conquer , Michelle Lott and Tianna Benson unpack what really goes into preparing an FDA 510(k) submission — from substantial equivalence and predicate devices to the eSTAR template , testing requirements , and why your submission is basically a regulatory novel. They also cover the difference between traditional , special , and abbreviated 510(k) pathways, the myths around timelines, and why “just throw money at it” never works when you’re waiting on biocompatibility results. In this episode, you’ll learn: How to structure your 510(k) as a cohesive “story” What FDA reviewers actually look for (and what confuses them) The role of risk management , human factors , and performance testing What the eSTAR template really does — and doesn’t — simplify When to use special vs. traditional 510(k) submissions How to avoid common rookie mistakes and review delays Why patience, precision, and planning matter more than funding Watch the video on YouTube: https://youtu.be/1XuGuLRsFyY Be sure to subscribe to the Device & Conquer podcast forbold…

People in this episode

Host: Michelle Lott

Guest: Tianna Benson

Topics covered

• FDA submission
• 510(k) pathways
• regulatory process
• risk management
• performance testing
• medtech regulation

Keywords

• 510(k)
• FDA
• eSTAR template
• risk management
• performance testing
• submission pathways
• biocompatibility
• regulatory novel

Mentioned in this episode

Organizations: FDA

Products: 510(k), eSTAR template, biocompatibility

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