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비즈니스 · 2026. 1. 23.1 분 읽기
Cuffless Non-Invasive Blood Pressure Measuring Devices-Clinical Performance Testing and Evaluation; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
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요약
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Cuffless Non-invasive Blood Pressure Measuring Devices--Clinical Performance Testing and Evaluation." This draft guidance provides recommendations for clinical performance testing and evaluation to support premarket submissions for cuffless non-invasive blood pressure measuring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 This draft guidance is not final nor is it for implementation at this time.
원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →