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National Diabetes Volunteer Leadership Council (NDVLC) Urges FDA to Enforce Stringent Accuracy Standards for Blood Glucose Monitoring Systems
Date:9/9/2013

BETHESDA, Md., Sept. 9, 2013 /PRNewswire-USNewswire/ -- Today, representatives from the U.S. Food and Drug Administration (FDA), industry and the diabetes advocacy community will convene at a Diabetes Technology Society meeting in Bethesda, Md., to discuss possible solutions for verifying the accuracy of self-monitoring blood glucose (SMBG) systems. The following statement can be attributed to Larry Ellingson, spokesperson for the National Diabetes Volunteer Leadership Council (NDVLC) and past chair of the American Diabetes Association board (2005):

"On behalf of the NDVLC and the 25.8 million Americans living with diabetes, we applaud the efforts of the Diabetes Technology Society to examine the very serious and potentially life-threatening issue of inaccurate SMBG systems. Patients with diabetes rely on these systems to guide the decisions they make multiple times a day about their disease management, and it is crucial that the information is accurate to avoid putting their health at risk.

We look forward to hearing from the FDA today on ways they plan to enforce accuracy standards equally among all SMBG manufacturers. It is simply unacceptable that up to 45 percent of the systems marketed globally to patients with diabetes do not meet the minimum accuracy requirements post-approval and that some manufacturers have failed to provide the FDA with the requisite medical device reporting (MDR) of adverse events.

The NDVLC encourages the FDA to closely examine and enforce the approval and testing processes for these devices to create a safer environment for patients living with diabetes. The FDA should use their existing authority to ensure the health and safety of patients with diabetes while considering any new approval standards, validation, and continuous monitoring of SMBG systems post-clearan
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SOURCE National Diabetes Volunteer Leadership Council
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