Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use; Guidance for Industry and Food and Drug Administration Staff; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use." This guidance describes studies and information that FDA recommends be used when submitting premarket notifications (510(k)s) for blood glucose monitoring systems (BGMSs) that are for prescription point-of-care use.