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…