FDA Splits Approach To Diabetes Meter Approvals

Law360, New York (January 7, 2014, 6:50 PM EST) -- The U.S. Food and Drug Administration on Tuesday proposed new approval standards for blood glucose monitors widely used by diabetics, distinguishing for the first time between devices sold over the counter and those intended for professional use.

In a pair of guidances, the FDA said it decided to adopt a two-pronged approach after coming to the conclusion that monitors present different risks depending on whether they're used at home or in a medical environment.

"It has become increasingly clear that these different use settings create distinct...
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