The Regulatory Crux with Artificial Intelligence as a Medical Device

Summary

Presently, we are living in the Stone Age of Artificial Intelligence. While we can see the short-term benefits of Artificial Intelligence (AI) or Machine Learning (ML) devices in many fields including healthcare and can imagine potential long-term benefits as AI evolves, there are also risks that cannot be ignored. Technological advancements in software capabilities for medical devices evolve quickly. Although AI has been present for decades, in recent years the proliferation of regulatory policies, guidance materials and rulemaking may seem overwhelming and challenging to navigate, leaving an AI developer or manufacturer wondering if a particular topic really applies to their AI product. This white paper discusses the current regulatory state and highlights critical quality practices for AI medical products.