The FDA pre-submission (Q-Sub) process can save you time — or sink your submission. In this episode of Device and Conquer, Michelle Lott and Tianna Benson explain how to Pre-Sub like a pro.
They explain when to use a pre-sub, how to structure your questions, and what to expect from FDA’s new eSTAR electronic template. Plus: insider tips on labeling, clinical protocols, and the art of “Does FDA concur?”
You’ll learn:
How to use pre-subs to guide your FDA reviewer’s thinking
What makes a strong vs. weak pre-sub question
The difference between protocols and data (and why it matters)
The risks of vague, open-ended questions
Why IFUs and labeling now drive early FDA interpretation
How FDA feedback lives forever — even from 10 years ago
Listen in and learn how to master the FDA pre-sub process and get insights that will help you move your device forward.
Watch the video on YouTube: https://youtu.be/XIJ2SAyAF9w
Be sure to subscribe to the Device and Conquer podcast for bold, insightful conversations that make medtech regulation make sense.
Visit us at https://leanraqa.com/ for evenmore 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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