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

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: Be sure to

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How to Submit a Pre-Sub (like a Pro) Device & Conquer S2:E2 is an episode from RA/QA Today by RAQA Today.

This episode is 00:16:50 long.

This episode was published on Oct 28, 2025.

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