Summary:
- The FDA has released long-awaited guidance on the regulation of artificial intelligence (AI) and machine learning (ML) in medical devices.
- The guidance outlines the FDA's proposed approach to regulating AI/ML-based software as a medical device, including requirements for transparency, monitoring, and change control.
- The guidance aims to provide a flexible, risk-based regulatory framework that encourages innovation while ensuring the safety and effectiveness of AI/ML-based medical devices.