> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Posts Guidance on OTC Glucose Systems
- URL: https://www.fdaweb.com/fda-posts-guidance-on-otc-glucose-systems/
- Published: 2016-10-07T12:00:00.000Z
- Updated: 2026-09-14T21:38:11.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5137025

FDA has posted a [guidance](http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM380327.pdf?ref=fdaweb.com) on “Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use” that describes studies and criteria the agency recommends when submitting 510(k)s for such devices. The document is intended to guide manufacturers in conducting appropriate performance studies and preparing submissions. The guidance is not meant to address blood glucose monitoring test systems which are intended for prescription point-of-care use in professional healthcare settings. A separate [guidance](http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceD13ocuments/UCM380325.pdf?ref=fdaweb.com) addresses those devices.