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