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Negócios · 29/09/20201 min de leitura
Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use; Guidance for Industry and Food and Drug Administration Staff; Availability
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Resumo
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.
Idioma original da fonte: Federal Register — Food and Drug AdministrationAbrir o comunicado original →