This episode of MedTech Global Insights demystifies the FDA's De Novo classification pathway, a critical tool for innovators bringing novel, low-to-moderate risk medical devices to the U.S. market. We explore how this pathway provides a solution for groundbreaking technologies that lack a predicate device, avoiding the costly and burdensome Premarket Approval (PMA) process. We discuss the strategic advantages of being the first to market, as a successful De Novo submission establishes a new device classification, making your product the benchmark for future competitors. This episode provides a clear overview of what the De Novo process entails, the type of evidence required, and how it fuels true innovation in the MedTech space. A Case in Point: Imagine you've developed a revolutionary AI diagnostic tool. It's not high-risk, but since it's the first of its kind, the standard 510(k) pathway is blocked, and the high-risk PMA pathway seems like a dead end. This costly dilemma, which can stall promising innovations, is exactly what the De Novo process is designed to solve. What you'll learn in this episode: - What is the "predicate trap" and how does the De Novo pathway help you escape it? - Is your novel device a better fit for De Novo or a Premarket Approval (PMA)? - What are the two distinct ways to initiate a De Novo request with the FDA? - How can a successful De Novo submission create a significant competitive advantage for your company? - What are the critical components of a De Novo dossier needed to prove a favorable risk-benefit profile? - Why is AI-powered diagnostic software a perfect example of a De Novo candidate? - What are the common pitfalls to avoid when preparing your De Novo submission? To learn more or discuss your regulatory strategy, contact us at [email protected] or visit https://pureglobal.com/.