Your First FDA Conversation: A Practical Guide to the Pre-Submission Process

​When should an early-stage medical-device team approach the FDA, and what should they prepare? This session introduces the FDA Pre-Submission process, covering when to consider a Pre-Sub, how to frame useful questions, and what information to bring to the conversation.

​Inquisito Labs co-founders Camille Chua and Shaurya Srivastav will walk through a practical example, followed by a short demonstration of how Inquisito helps teams organize research and prepare a Pre-Submission draft. The session includes Q&A and time afterward to discuss attendees’ projects individually.

​Shaurya Srivastav, Co-founder and CEO
Shaurya Srivastav is co-founder and CEO of Inquisito Labs and an AI researcher at UC Davis. He previously worked on AI for site reliability engineering at Apple and machine-learning systems at United Airlines. At Inquisito, he builds tools that help medical-device teams turn research and technical information into organized, reviewable regulatory submission drafts.

​Camille Chua, Co-founder
Camille Chua is co-founder of Inquisito Labs and a medical-device regulatory professional with over a decade of experience. She brings a regulatory practitioner’s perspective to product development, helping shape tools around the research, evidence, and documentation device teams need. She will lead the session’s discussion on preparing for a productive FDA Pre-Submission.

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