FDA Debates Framework for AI-Based Medical Devices

A reimagined approach to premarket review for AI and machine learning–driven modifications to medical devices is underway at the federal agency. The FDA is crafting a new regulatory framework to promote the development of safe and effective medical devices powered by advanced artificial intelligence algorithms. The agency sees promise in adaptive AI and machine learning technologies, noting they “have the potential to adapt and optimize device performance in real time to continuously improve healthcare for patients.”

Under the current rules, any changes made in medical devices’ software requires FDA approval. But that rule would be burdensome for companies that make adaptive software powered by AI and machine learning because the software is continuously changing — and improving — as it gathers data.