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The high burden of traditional FDA clearance drives many novel, AI-enabled mental health devices into unregulated consumer markets. The new FDA-CMS TEMPO pilot program establishes a vital regulatory middle ground, allowing companies to commercialize using a Quality Management System without immediate premarket authorization. This commentary explores how TEMPO serves as a sandbox for real-world data, offering a blueprint to reshape the future of US digital health regulation.
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Parks et al. (2026) studied this question.
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