Generative artificial intelligence (GenAI) medical devices are gradually coming to market, prompting the US Food and Drug Administration (FDA) to consider its regulatory approach to the technology.
Given the rise of GenAI-based medical devices, a form of the technology that, unlike regular AI, can make decisions autonomously, with little or no human input, the FDA released a 30-page discussion paper outlining a more formalised approach to the regulation of GenAI-based medical devices in August
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Highlighting that GenAI-enabled medical devices hold transformative promise for patient care and the broader health ecosystem, the paper also noted that such devices hold the potential to introduce unique risks compared to existing technology.
Ross Law, editor of Medical Device Network, spoke with Dennis Gucciardo, partner at law firm Morgan Lewis, to learn more about the release of the FDA’s paper and its main aims as GenAI advances.
Listen to the full episode below:
