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# FDA to Scrutinize AI-Powered Mental Health Devices
- URL: https://www.fdaweb.com/fda-to-scrutinize-ai-powered-mental-health-devices/
- Published: 2025-09-11T12:00:00.000Z
- Updated: 2026-09-14T15:21:30.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159853

FDA has scheduled an 11/6 Digital Health Advisory Committee meeting to examine the rise of generative artificial intelligence (AI) in digital mental health medical devices, signaling heightened concern from the agency about the technology’s risks and regulatory gaps. AI-based mental health devices are increasingly being promoted as tools to expand access to mental health care. With demand for mental health services in the U.S. far outpacing available providers, such devices are being explored as potential solutions to bridge the care gap.

However, FDA officials warn that the technology comes with “novel risks.” As AI systems grow more complex and begin to play a role in diagnosing and treating mental health conditions, regulators face pressure to ensure patient safety without stifling innovation.

[FDA says](https://public-inspection.federalregister.gov/2025-17651.pdf?ref=fdaweb.com) the committee will discuss the “benefits, risks to health, and risk mitigations that might be considered for these new digital mental health devices, including premarket evidence and postmarket monitoring considerations. The committee will weigh the potential benefits of AI-enabled devices against their risks, including concerns about accuracy, bias, misuse, and the adequacy of clinical evidence. Members will also consider what types of premarket evidence should be required and how companies should monitor their products once they are on the market.”