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New Glucose Monitor Standard Could Come With Trade-Offs
As the FDA seeks to tighten the accuracy standard for blood glucose meters used by diabetics, devicemakers are reminding the agency that a stricter standard would result in trade-offs without solving all the problems.
The current standard requires meters to be accurate within 20 percent, and companies commenting at an FDA workshop supported tightening the standard to 15 percent.
Going beyond that could lead to the loss of user conveniences such as small blood samples and quicker response times, Steven Brotman, a senior vice president at AdvaMed, said at the workshop.
The GMP Letter
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