The FDA has released draft guidance for cuffless non-invasive blood pressure measuring devices, outlining recommendations for clinical performance testing. This guidance is currently not final and is intended to support premarket submissions.
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Cuffless Non-invasive Blood Pressure Measuring Devices--Clinical Performance Testing and Evaluation." This draft guidance provides recommendations for clinical performance testing and evaluation to support premarket submissions for cuffless non-invasive blood pressure measuring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 This draft guidance is not final nor is it for implementation at this time.
Original title: “Cuffless Non-Invasive Blood Pressure Measuring Devices-Clinical Performance Testing and Evaluation; Draft Guidance for Industry and Food and Drug Administration Staff; Availability”