Portable blood glucose meters that measure blood glucose values are used by millions of 28 people with diabetes every day as an aid in diabetes self-management. In recent years, concerns have been raised related to infection control issues involving blood glucose meters and lancing devices. This guidance 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) which are for over-the-counter (OTC) home use by lay-users.
The device types addressed in this guidance document typically uses capillary whole blood from fingertip or alternative anatomical sites. This guidance document is limited to SMBGs, which are regulated under 21 CFR 862.1345, Glucose Test System. The product code NBW applies to SMBGs. This document is not meant to address the following types of devices:
- Blood glucose monitoring test systems intended for use in prescription point-of-care in professional healthcare settings (e.g., hospitals, physician offices, long term care facilities, etc.)
- Devices used to screen and diagnose diabetes (such as clinical chemistry analyzers).
- Continuous glucose sensors, implanted or external (e.g., continuous glucose monitoring systems (CGMs) or sensors within catheters).
- Non-invasive glucose measurement devices, (i.e., devices that do not require removal of a blood sample from a fingertip or other anatomical site).
- Devices for measurement of blood glucose in neonates.
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