Association of Diabetes Care & Education Specialists

News & Publications

New FDA Blood Glucose Monitoring Guidance Documents

Jan 25, 2017

The Food and Drug Administration (FDA) recently released two guidance documents on blood glucose monitoring test systems. They detail the agency’s recommendations for manufacturers to improve blood glucose meters in professional healthcare and home use settings.

The FDA created these separate guidance documents because it “believes each of the devices can be better designed to meet the needs of their intended use populations, thereby providing greater safety and efficacy.”

Read Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use and Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use.

In This Section

News & Publications