Arlington, VA-The American Consumer Institute (ACI) submitted comments to the FDA warning that labeling general wellness AI mental health chatbots as medical devices would limit access, raise costs, and undermine support tools millions rely on amid a nationwide mental health shortage.
ACI emphasized that these chatbots are not intended to diagnose or treat medical conditions and therefore do not meet the FDA’s own definition of a medical device. The organization highlighted evidence that wellness chatbots are increasingly effective, safe, and built with input from mental health professionals.
ACI urged the FDA to avoid premature regulation that could disrupt affordable wellness tools and recommended revisiting the issue only after the technology and market continue to evolve.
Read ACI’s public comments here.
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The American Consumer Institute is a nonprofit education and research organization.