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# OTC Blood Glucose Monitor Guidance
- URL: https://www.fdaweb.com/otc-blood-glucose-monitor-guidance/
- Published: 2016-10-11T12:00:00.000Z
- Updated: 2026-09-14T21:38:35.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137054

*Federal Register* Notice: FDA has made available a guidance entitled “Self-Monitoring Blood Glucose Test Systems for Over- the-Counter Use.” The document describes studies and criteria that FDA recommends be used when submitting premarket notifications (510(k)s) for self-monitoring blood glucose test systems intended for over-the-counter home use by lay-users. To view the guidance, click [here](http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM380327.pdf?ref=fdaweb.com). To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-10-11/pdf/2016-24431.pdf?ref=fdaweb.com).