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Clinical Trial Events
SOCRA 18th Annual Device Research & Regulatory Conference

Talk

FDA Regulation of Digital Health Technologies, Artificial Intelligence and Machine Learning – An Evolving Regulatory Landscape

Thu, Apr 24, 2025 · 1:00–2:00 PM PDT Hyatt Regency Newport Beach

About this session

Digital Health Technologies and devices that incorporate artificial intelligence/machine learning  continue to proliferate. We’ll review FDA’s current regulatory framework for medical devices and how these products fit in, as well as FDA’s expectations for development of devices that use artificial intelligence/machine learning.  We’ll also discuss current guidance that companies should consider when planning their regulatory strategy, and developments that may be on the horizon.

Speaker