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Blood Glucose Meter Accuracy Problems Acknowledged By FDA, Industry And Clinicians

Certain 510(k)-cleared blood glucose meters do not perform at the regulatory standards for which they were cleared after they hit the market, stakeholders agree. FDA is working on the matter, but no clear plan of action was laid out at a Diabetes Technology Society meeting last week.

The Diabetes Technology Society sponsored a meeting last week entitled, “Do Currently Available Blood Glucose Monitors Meet Regulatory Standards?” The resounding answer from participants: No.

Clinicians, industry, academics and FDA agreed that certain 510(k)-cleared blood glucose meters do not perform at the regulatory standards for which they were cleared after they hit the market.

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