FDAnews Device Daily Bulletin

GUIDANCE ISSUED REGARDING IN VITRO DIAGNOSTICS

April 10, 2006
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The FDA has issued the guidance, "In Vitro Diagnostic Devices to Detect Influenza A Viruses: Labeling and Regulatory Path," to inform industry and agency staff of recommended steps to ensure the safe and effective use of in vitro diagnostic (IVD) devices intended for use in the detection of influenza A viruses from humans. The agency said it is taking this action because of the recent public health concerns associated with emergence of an avian influenza A virus strain as a human pathogen in Southeast Asia.

This guidance document addresses recommendations for fulfilling labeling requirements applicable to all IVDs intended to detect the influenza A virus directly from human specimens, with a particular emphasis on ensuring appropriate labeling for legally marketed influenza A test devices.

This document also outlines the premarket regulatory path for new or modified devices intended to detect influenza A viruses, or intended to detect and differentiate a specific novel influenza A virus infecting humans. It also includes broad recommendations regarding information for assessing the clinical performance and utility of all such devices.

For more information visit, http://www.fda.gov/cdrh/oivd/guidance/1594.html (http://www.fda.gov/cdrh/oivd/guidance/1594.html).