FDA Guidance on Machine Learning, AI in Medical Devices a Notable Step Toward Modernization

Inside Digital Health May 17, 2019
Christopher McCann

The U.S. Food and Drug Administration (FDA) is seeking comments on proposed new rules and regulationsgoverning medical devices that are enabled by machine learning (ML) and artificial intelligence (AI). The proposed regulatory framework for AI and ML technologies would allow for modifications to be made following real-word deployments, learnings and adaptations. It’s a worthy first step toward modernization, but the regulator must embrace further innovation.

The move shows the FDA recognizes that the future of medical devices and software involves ML models and AI applications. It also suggests that, as an agency, the FDA is becoming more innovative and knows that past regulations simply aren’t appropriate in the modern context. Medical device innovation was once unhurried and gradual, so it...

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