FDA Provides Perspective on Goals and Challenges for Regulation of Artificial Intelligence in Medical Devices, Drug Design, and Clinical Research

Lexology November 22, 2024
Knobbe Martens

A recent article[1] authored by Haider J. Warraich, MD[2]; Troy Tazbaz[3]; and Robert M. Califf[4], MD in the Journal of the American Medical Association, reviews the history of artificial intelligence (AI) regulation by the U.S. Food and Drug Administration (FDA) and provides perspective from the FDA regarding considerations the agency faces in regulating potential uses of AI in medical products, clinical research and drug design, as well as the challenges it faces in adapting the regulatory system to new technologies that require continuous feedback.

The FDA has been evaluating AI-enabled medical devices for nearly 30 years with the FDA’s first approval of a partially AI-enabled device coming in 1995, when the FDA approved PAPNET, a software employing neural networks for...

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