Medical devices; general hospital and personal use devices; classification of the filtering facepiece respirator for use by the general public in public health medical emergencies. Final rule.

  • Published 2007 in Federal register

Abstract

The Food and Drug Administration (FDA) is classifying the filtering facepiece respirator for use by the general public in public health medical emergencies into class II (special controls). The agency is classifying these devices into class II (special controls) in order to provide a reasonable assurance of the safety and effectiveness of these devices and… (More)

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