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

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, 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 future session? Drop it in the comments below!

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for even more regulatory goodness andto learn more about our services.
📩Gota question or a topic for a future session? Drop it in the comments below!

#FDA #RegulatoryAffairs #MedicalDevices #MedTech #Compliance#PreSub#QualitySystems #submissions #commercialization #startups#productlaunches#businessdevelopment