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: https://youtu.be/XIJ2SAyAF9w

Be sure to subscribe to the Device and Conquer podcast for bold, insightful conversations that make medtech regulation make sense.

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