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In Brief: FDA blood glucose monitor guidance

This article was originally published in The Gray Sheet

Executive Summary

FDA blood glucose monitor guidance: Agency planning to form working group comprised of FDA, industry reps, patients, nurse educators and other healthcare professionals to gain input on ways to improve the agency's revised guidance on self-monitoring blood glucose monitors. FDA's Clinical Chemistry and Clinical Toxicology Panel recommended greater cooperation between the various parties at its March 20-21 meeting, which was held to discuss ways to minimize problems related to the devices ("The Gray Sheet" March 31, p. 12). The widely used products generate the most adverse event reports of all in vitro diagnostics...
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