FDA Issues Discussion Paper on Artificial Intelligence and Machine Learning in Medical Devices

The FDA recently issued a discussion paper and request for feedback titled, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning [AI/ML]-Based Software as a Medical Device.” The challenge artificial intelligence (AI) and machine learning (ML) present to FDA device regulation is straightforward: the FDA must approve or clear devices as safe and effective, yet some forms of AI or ML software can adapt and change as they obtain new data or otherwise gain experience.