This week, we dissect the FDA's groundbreaking new draft guidance on AI/ML-enabled medical devices. This isn't just another regulation. it's a paradigm shift that redefines the rules for software as a medical device. We explore how the requirement for a "Predetermined Change Control Plan" (PCCP) is creating significant new hurdles for innovators in the MedTech space.

We break down what this means for manufacturers, from startups to enterprise leaders. For instance, a company with a brilliant, continuously learning algorithm for early cancer detection now faces a critical challenge: how to innovate at speed while adhering to a rigid framework that demands every significant update be pre-planned and validated. This episode provides the insights you need to navigate this new reality.

What You'll Learn:

- What exactly is the FDA's new guidance for AI devices, and why does it demand your immediate attention?

- How does a "Predetermined Change Control Plan" work, and what are the hidden complexities?

- Could your self-improving algorithm become your biggest regulatory liability?

- Why do continuous learning models face the most significant challenges under these new rules?

- How will this U.S. policy shift impact your global market access strategy, including CE marking in Europe?

- What are the essential documentation and risk management strategies you must implement now?

- Is this new regulatory friction signaling a slowdown for rapid innovation in AI MedTech?

For more information, contact us at [email protected], visit https://pureglobal.com/, or access our FREE AI tools and medical device database at https://pureglobal.ai/.