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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Rule and guidance for emergency face masks: FDA final 1rule down-classifies filtering facepiece respirators for use in public health emergencies to Class II. The rule also requires that the devices be certified by the National Institute for Occupational Safety and Health and that manufacturers address additional issues discussed in a July 3 2guidance. The device, a disposable half-facepiece non-powered air-purifying particulate respirator, is intended to cover the nose and mouth to reduce exposure to pathogenic biological airborne particulates, for instance during a flu pandemic. FDA's guidance, "Class II Special Controls Guidance Document: Filtering Facepiece Respirator for Use by the General Public in Public Health Medical Emergencies," details how manufacturers can assure good filtration and breathability, proper fit and use, and gentleness to the wearer's skin. 3M, maker of the recently cleared 8612F and 8670F facepiece respirators, requested the Class II designation for the new device type last October (3"The Gray Sheet" May 14, 2007, p. 18)...

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