Unlocking MedTech Innovation: A Deep Dive into the FDA's AI Change Control Policy with Pure Globa... скачать в хорошем качестве

Unlocking MedTech Innovation: A Deep Dive into the FDA's AI Change Control Policy with Pure Globa...

In this episode of MedTech Global Insights, we dissect the FDA's groundbreaking final guidance on Predetermined Change Control Plans (PCCPs) for AI/ML-enabled medical devices. We explore how this new framework moves beyond the traditional, rigid regulatory submission process, creating a streamlined pathway for manufacturers to innovate and improve their smart devices safely and effectively. Discover how a PCCP can unlock the full potential of your adaptive medical software. We'll use the example of an AI-powered diagnostic imaging tool that continuously learns from new data. The pain point is clear: without a PCCP, every minor algorithm update could mean a new, costly submission to the FDA, stalling innovation. With a well-crafted PCCP, the company can deploy performance-enhancing updates swiftly, as long as they fall within the pre-approved plan, ensuring patients get the best technology faster. Key Takeaways: What is an FDA Predetermined Change Control Plan and why is it a game-changer for AI/ML medical devices? How do you define the scope of planned modifications without limiting future innovation? What are the essential components of a "Modification Protocol" that will satisfy regulators? How can you demonstrate that your device will remain safe and effective after multiple algorithm updates? What are the best practices for documenting the verification and validation process for each change? How does a PCCP impact the post-market surveillance and reporting requirements for your device? What common pitfalls should manufacturers avoid when preparing their PCCP submission? How can a strategic regulatory partner help you leverage the PCCP framework for faster global market access? Contact us at [email protected] or visit https://pureglobal.com/ for more information.