Cyanoacrylate Skin Adhesives Should Be Down-Classified – FDA Panel
This article was originally published in The Gray Sheet
Executive Summary
Cyanoacrylate tissue adhesives used to close small wounds pose sufficiently minor risks to justify down-classification to Class II, according to FDA's General & Plastic Surgery Devices panel
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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)...
Health And Wellness Weekly Trademarks Review: 16 April
Trademarks are registered and published for opposition with the US Patent and Trademark Office and are published weekly in the agency's Official Gazette.