FDA与CMS推出TEMPO试点计划，为AI心理健康产品提供监管中间地带
The TEMPO program and the future of digital mental health regulation in the US
FDA新开了一个TEMPO通道，AI心理健康产品可以先卖再补审批，做数字健康的朋友看看这个沙盒怎么玩。
npj Digital Medicine 刊发的评论文章分析了美国 FDA 与 CMS 联合推出的 TEMPO 试点计划。传统 FDA 审批门槛高，许多 AI 心理健康设备因此流入不受监管的消费市场。TEMPO 允许企业以质量管理体系（QMS）先行商业化，无需立即获得上市前授权。文章认为该计划相当于用真实世界数据做监管沙盒，可能重塑美国数字健康的监管框架。
The TEMPO program and the future of digital mental health regulation in the US
npj Digital Medicine, Published online: 03 November 2026; doi:10.1038/s41746-026-03464-x 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.
