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# Draft Guide on OTC Blood Glucose Monitors
- URL: https://www.fdaweb.com/draft-guide-on-otc-blood-glucose-monitors/
- Published: 2018-11-30T12:00:00.000Z
- Updated: 2026-09-15T00:47:57.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142930

*Federal Register* notice: FDA has made available a draft guidance entitled “Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use.” The document describes studies and information that the agency recommends be used when submitting 510(k)s for self-monitoring blood glucose test systems that are for over-the-counter home use by lay users. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-11-30/pdf/2018-26028.pdf?ref=fdaweb.com).