FDA Rules, Regulations and Resources for Artificial Intelligence in Medical Devices

Healthcare & Life Sciences attorney Sara Klock wrote an article for Medical Design & Outsourcing on the U.S. Food and Drug Administration's (FDA) regulation of artificial intelligence (AI) and machine learning (ML) in medical devices. She explains when software and AI-enabled products qualify as regulated devices according to the Federal Food, Drug, and Cosmetic (FD&C) Act and distinguishes between those falling under FDA enforcement discretion and those requiring agency review through pathways such as 510(k), de novo classification or premarket approval. Ms. Klock also summarizes FDA guidance in this area, such as documents on Clinical Decision Support (CDS) Software, best practices for ML medical device development and recommendations for submissions involving AI-enabled software. She emphasizes that even minor product changes may trigger government oversight, which underscores the need for proactive planning.

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