FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: CUFFLESS NON-INVASIVE BLOOD PRESSURE MEASURING DEVICES-CLINICAL PERFORMANCE TESTING AND EVALUATION; DRAFT GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF; AVAILABILITY

WASHINGTON, Jan. 23 -- Food and Drug Administration has issued a notice called: Cuffless Non-Invasive Blood Pressure Measuring Devices-Clinical Performance Testing and Evaluation; Draft Guidance for Industry and Food and Drug Administration Staff; Availability.

The notice was published in the Federal Register on Jan. 23 by Lowell M. Zeta, Acting Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Cuffless Non-invasive Blood Pressure Measuring Devices-Clinical Performance Testing and Evaluation." This draft guidance provides recommendations for clinical performance testing and evaluation to support pr...