2026-01288: Cuffless Non-Invasive Blood Pressure Measuring Devices-Clinical Performance Testing and Evaluation; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Cuffless Non-invasive Blood Pressure Measuring Devices--Clinical Performance Testing and Evaluation." This draft guidance provides recommendations for clinical performance testing and evaluation to support premarket submissions for cuffless non-invasive blood pressure measuring devices. This draft guidance is not final nor is it for implementation at this time.
The agency’s own summary, as published.
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