Article preview from "The Gray Sheet" - May 27, 2013
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.
Blood Glucose Meter Accuracy Problems Acknowledged By FDA, Industry And Clinicians
Article preview from "The Gray Sheet" - May 27, 2013
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.
“The problem is that there are some blood glucose monitors on the market which perform less accurately than the standards would specify and it’s these standards which led them to be approved,” explained David Klonoff, a clinical professor of medicine at the University of California, San Francisco, in an interview.
FDA currently follows the International Organization for Standardization (ISO) 15197:2003, “Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus” when assessing blood glucose meter 510(k) pre-market applications. On May 15, ISO published a revised 15197:2013 standard
, which has stricter accuracy guidelines for blood glucose meters, although FDA has yet to adopt it.
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