2025-22190: Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot
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The Food and Drug Administration's (FDA's) Center for Devices and Radiological Health (CDRH) is announcing its Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot ("TEMPO pilot"), in connection with the Center for Medicare and Medicaid Innovation (CMMI) Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model, to promote access to certain digital health devices while safeguarding patient safety.
The agency’s own summary, as published.
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