How to Submit a Pre-Sub (like a Pro) | Device & Conquer | S2:E2

About this episode

This episode discusses how to effectively navigate the FDA pre-submission process for medical devices.

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…

People in this episode

Host: Michelle Lott

Guest: Tianna Benson

Topics covered

• FDA pre-submission process
• medical device regulation
• clinical protocols
• labeling
• insider tips
• submission strategies

Keywords

• pre-submission
• FDA
• medical devices
• regulatory affairs
• clinical protocols
• labeling
• submission strategies
• eSTAR
• insider tips

Mentioned in this episode

Organizations: FDA, Device and Conquer, leanraqa

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