LTR 59: FDA's pre-sub program and how it can accelerate medical device innovation

“You can get a lot of valuable insights from the FDA on what your regulatory pathway is when it comes to risk, and how that impacts not only the risk of the product but how you set up your quality systems and what you need to implement in the long run. ”In this Let’s Talk Risk! conversation, Amit Guruprasad shares how small medical device manufacturers and startups can take advantage of the free pre-sub program to get early feedback from the FDA to inform their regulatory strategy and plans for collecting data to prove safety and effectiveness in their final regulatory submission. But it requires a strategic approach and preparation before you meet with the FDA. As an example, you should plan to get FDA feedback on your proposed approach and not seek yes/no answers. Listen to this Let’s Talk Risk! conversation with Amit Guruprasad, which also includes an open discussion with a live audience. Jump to a section of interest using these timestamps.00:02:12 Introduction00:04:20 FDA’s Q-Sub program, pre-submissions and risk determination00:07:11 How to prepare for a pre-sub meeting with the FDA00:10:05 Develop a strategic plan for pre-sub meetings with FDA00:12:05 Plan to get feedback on the approach and not answers to yes/no questions00:12:50 Lessons learned from a recent pre-sub meeting00:14:25 Audience Q&A and general discussion00:31:25 Closing comments and key takeawaysIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:The Q-Submission Program: FDA guidance for requesting a meeting for feedback on medical device submissions. DICE: FDA’s division of industry and consumer education.LTR webinar on post-market surveillanceAbout Amit GuruprasadAmit Guruprasad is the founder of Devan MedTech Solutions, where he provides quality and regulatory consulting services to medical device companies and startups. He has over 10 years of professional experience in R&D, quality and regulatory affairs at various medical device companies. He holds B.S. and M.S. in Biomedical Engineering. Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.DisclaimerInformation and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe