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Entreprise · 23/01/20261 min de lecture
Cuffless Non-Invasive Blood Pressure Measuring Devices-Clinical Performance Testing and Evaluation; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
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Résumé
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Cuffless Non-invasive Blood Pressure Measuring Devices--Clinical Performance Testing and Evaluation." This draft guidance provides recommendations for clinical performance testing and evaluation to support premarket submissions for cuffless non-invasive blood pressure measuring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 This draft guidance is not final nor is it for implementation at this time.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →