Shari Esfahani

Orrick, Herrington & Sutcliffe LLP

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FDA Issues Draft Guidance on AI-Enabled Medical Devices

The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices. The Importance of Engaging Early Sponsors of AI-enabled devices should engage with the...more

1/8/2025  /  Artificial Intelligence , Bias , Cybersecurity , Data Management , Food and Drug Administration (FDA) , Medical Devices , Regulatory Requirements , Risk Management , Software , Transparency
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