FDA Publishes Discussion Paper on Regulating Generative AI-Enabled Med Devices

By In Compliance,

2026-09-17

The U.S. Food and Drug Administration (FDA) has published a discussion paper to engage medical device manufacturers and other stakeholders on issues related to the development, regulation, and use of advanced medical devices that incorporate generative artificial intelligence (AI) technology. The discussion paper, titled “Considerations for the Regulation of Generative...