Self-Monitoring Blood Glucose Test Systems for Over-the-Counter 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 the guidance entitled "Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use." This document describes studies and criteria that FDA recommends be used when submitting premarket notifications (510(k)s) for self-monitoring blood glucose test systems (SMBGs) intended for over-the-counter (OTC) home use by lay-users. FDA intends for this document to serve as a guide for manufacturers in conducting appropriate performance studies and preparing 510(k)s for these device types.