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# FDA Guide on Glucose Monitoring Systems
- URL: https://www.fdaweb.com/fda-guide-on-glucose-monitoring-systems/
- Published: 2016-10-07T12:00:00.000Z
- Updated: 2026-09-14T21:38:16.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5137030

FDA has released a [guidance](http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM380325.pdf?ref=fdaweb.com) on “Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use” that describes studies and criteria that FDA recommends be used when submitting 510(k)s for such devices. The document is intended to guide manufacturers in conducting appropriate performance studies and preparing submissions. The agency says it is not meant to address self-monitoring blood glucose test systems for over-the-counter home use. A separate [guidance](http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceD16ocuments/UCM380327.pdf?ref=fdaweb.com) covers OTC tests.