The Future of AI in Medical Device Regulation
How Artificial Intelligence is reshaping the landscape of FDA and MDR compliance.
AI is Here
The medical device industry is undergoing a seismic shift. With the FDA's increasing acceptance of AI/ML-based Software as a Medical Device (SaMD), the regulatory landscape is evolving rapidly.
The Challenge
Traditional regulatory frameworks were built for locked algorithms. AI that learns and adapts poses a unique challenge: how do you validate something that changes?
The Solution: PCCP
The FDA's answer is the Predetermined Change Control Plan (PCCP). This allows manufacturers to pre-specify the boundaries of how their algorithm will adapt, essentially "validating the change protocol" rather than just the snapshot of the software.
Key Takeaways
- Plan Early: Define your change protocol during the design phase.
- Data Governance: Ensure your training data is robust and unbiased.
- Continuous Monitoring: Post-market surveillance is no longer optional; it is the lifeblood of AI safety.
Leanabl can help you navigate this complex new world. Contact us to learn more.