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, we, or Agency) is announcing the availability of the final guidance entitled "Self- Monitoring Blood Glucose Test Systems for Over-the-Counter Use." This guidance described studies and information that FDA recommends be used when submitting premarket notifications (510(k)s) for self-monitoring blood glucose test systems (SMBGs), which are for over-the-counter (OTC) home use by lay users. This guidance is not meant to address blood glucose monitoring test systems (BGMS) that are intended for prescription point-of-care use in professional healthcare settings (e.g., hospitals, physician offices, long-term care facilities).