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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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FDA Reclassifications In Brief

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FDA Reclassifications In Brief

Digital mammography: FDA 1proposes May 30 to downclassify full field digital mammography systems from Class III to Class II, following the 2006 recommendation of its Radiological Devices Panel (2"The Gray Sheet" May 29, 2006, p. 6). The agency also released a special controls 3draft guidance outlining proposed electrical safety and physical laboratory 510(k) testing requirements. Comments on the proposed reclassification and draft guidance are due Aug. 29

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FDA on May 8 510(k) cleared the first respirator masks that can help reduce the user's exposure to airborne germs during a public medical emergency, such as an influenza epidemic

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