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# AdvaMed Glucose Test System Guidance Comments
- URL: https://www.fdaweb.com/advamed-glucose-test-system-guidance-comments/
- Published: 2019-03-05T12:00:00.000Z
- Updated: 2026-09-15T01:09:56.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143530

AdvaMed says two FDA draft guidances on self-monitoring blood glucose test systems for over-the-counter use and prescription point-of-care use will “support accurate, reliable blood glucose monitoring test systems while also providing for innovation and continued investment in new technology.” In comment letters [here](https://www.regulations.gov/document?D=FDA-2013-D-1446-0021&ref=fdaweb.com) (over-the-counter) and [here](https://www.regulations.gov/document?D=FDA-2013-D-1445-0070&ref=fdaweb.com) (point of care), AdvaMed says the drafts provide important clarifications, including on study design and labeling. The association also provides specific recommendations for each guidance.