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# Draft Guide on Blood Glucose Monitoring 510(k)s
- URL: https://www.fdaweb.com/draft-guide-on-blood-glucose-monitoring-510-k-s/
- Published: 2018-11-30T12:00:00.000Z
- Updated: 2026-09-15T00:47:59.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142929

*Federal Register* notice: FDA has made available a draft guidance entitled “Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.” The document describes studies and criteria that FDA recommends be used when submitting 510(k)s for blood glucose monitoring systems that are for prescription point-of-care use. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-11-30/pdf/2018-26034.pdf?ref=fdaweb.com).