RAQA Today

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

28 Oct 2025

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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 thinkingWhat makes a strong vs. weak pre-sub questionThe difference between protocols and data (and why it matters)The risks of vague, open-ended questionsWhy IFUs and labeling now drive early FDA interpretationHow FDA feedback lives forever — even from 10 years agoListen 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/XIJ2SAyAF9wBe 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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13:00H | 21 DIC 2025 | Fin de Semana

01 Jan 1970

Fin de Semana

10:00H | 21 DIC 2025 | Fin de Semana

01 Jan 1970

Fin de Semana

12:00H | 20 DIC 2025 | Fin de Semana

01 Jan 1970

Fin de Semana

2ª PARTE | 06 ENE 2026 | EL PARTIDAZO DE COPE

01 Jan 1970

El Partidazo de COPE

3ª PARTE | 22 ENE 2026 | EL PARTIDAZO DE COPE

01 Jan 1970

El Partidazo de COPE

3ª PARTE | 04 MAR 2026 | EL PARTIDAZO DE COPE

01 Jan 1970

El Partidazo de COPE

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RAQA Today

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

This episode hasn't been transcribed yet

Other recent transcribed episodes

13:00H | 21 DIC 2025 | Fin de Semana

10:00H | 21 DIC 2025 | Fin de Semana

12:00H | 20 DIC 2025 | Fin de Semana

2ª PARTE | 06 ENE 2026 | EL PARTIDAZO DE COPE

3ª PARTE | 22 ENE 2026 | EL PARTIDAZO DE COPE

3ª PARTE | 04 MAR 2026 | EL PARTIDAZO DE COPE

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