FDA prepares guidance on medical devices with generative AI — STAT News

The US Food and Drug Administration (FDA) is developing a plan to regulate medical devices that use generative artificial intelligence. STAT News reports.

Formal guidance

Rick Abramson, director of the FDA’s Digital Health Center of Excellence, told the publication that the agency will eventually release documents outlining its policy on this technology.

According to Abramson, the FDA’s goal is to prepare formal guidance. He noted that stakeholders in this field expect greater clarity from the regulator, and the agency aims to provide it.

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General and specialized documents

Abramson said that the FDA may prepare not only broad guidance on generative AI in general. The agency also expects more narrowly focused specialized documents on specific uses of generative AI that are of particular interest or are complex.

This concerns the FDA’s policy on generative AI in medical devices. The timing of the publication of the future documents is not specified in the available part of the material.