USSandboxIn forceModel providersDeployersPlatforms
FDA TEMPO Pilot: Generative AI Medical Devices Path to Market Before Authorization
FDA TEMPO试点项目：生成式AI医疗设备提前上市
FDA·Published 2026-09-03·Checked by 管理员 on 2026-09-10
The U.S. Food and Drug Administration (FDA) has launched the TEMPO pilot program, accepting four generative AI medical devices, including products from Cadence and Limbic, which can be provided to patients before marketing authorization.
What it means for you
What to do
EveryoneStay informed about the FDA TEMPO pilot program updates
ProductEvaluate if your product is suitable for the TEMPO pilot program
CompliancePrepare relevant documents and materials
Key dates
2026-09-03Published
Source documents
Coverage
Stories in the feed
Editorial summary, not legal advice; dates and status follow the original document. · Report a correction