FDA Seeks Guidance from the Digital Health Advisory Committee on AI: Considerations for Innovators of Digital Mental Health Medical Devices and Wellness Products

Key Takeaways:

• On Nov. 6, the Food and Drug Administration’s (FDA) Digital Health Advisory Committee (DHAC) convened to discuss the promise and evolving challenges of Generative Artificial Intelligence (GenAI)-Enabled Digital Mental Health Medical Devices.
• The FDA acknowledged the challenges of applying traditional premarket and postmarket processes for static medical devices to rapidly evolving AI-enabled medical

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