Source: Food and Drug Law Institute

The Food and Drug Law Institute article reviews the current state of the U.S. Food and Drug Administration’s (FDA) oversight of artificial intelligence (AI) in medical applications. It examines how the FDA evaluates AI-powered medical devices, focusing on safety, effectiveness, and post-market monitoring.

Key developments include updated guidance on adaptive AI algorithms and their regulatory pathways. The FDA has also emphasized transparency, requiring developers to document changes in AI systems that could affect device performance. The article highlights ongoing challenges, such as balancing innovation with patient safety, and calls for more collaboration between regulators, healthcare providers, and AI developers.