Medical Autonomy: A Proposal for Modifying Regulation of Surgical Devices that Utilize Artificial Intelligence

This text delves into the regulatory landscape of new surgical technologies, emphasizing the complexities and variations in clinical risk classifications across countries. It questions the classification of autonomously functioning surgical robots and proposes a potential new classification to accommodate their unique features. Ethical considerations are explored, particularly in assigning responsibility for complications involving autonomous surgical devices. The regulatory approval process for medical devices is outlined, emphasizing the importance of design controls and quality management. The discussion extends to the challenges and potential biases in AI/ML algorithms, suggesting the need for specific regulations for AI-based surgical devices to foster innovation without compromising safety.