In Reply My Viewpoint called attention to a determination by the FDA that relabeled a class III device as accurate for use in dosing insulin, without the previously required need for a confirmatory blood glucose measurement. The decision was made despite more than 25 000 reports to the FDA of potentially harmful device inaccuracies. These reports were not mentioned to an advisory panel or directly addressed in the summary of safety and effectiveness data for the decision.
Shapiro AR. Continuous Glucose Monitors for Insulin Dosing—Reply. JAMA. 2018;319(13):1384. doi:10.1001/jama.2018.0212
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