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FDA Opens a CMS-linked Side Door: Use of Digital Health Devices Before Authorization Under the TEMPO Pilot

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Fda Opens A Cms-Linked Side Door: Use Of Digital Health Devices Before Authorization Under The Tempo Pilot

The U.S. Food and Drug Administration (FDA) announced the Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices Pilot, or “TEMPO pilot,” on December 5, 2025, alongside a Federal Register notice seeking statements of interest for participation….
By: Hogan Lovells

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