April 21, 2006

The FDA has issued guidance on in vitro diagnostic devices to detect Influenza A viruses. The guidance informs industry and agency staff of recommended steps to ensure the safe and effective use of in vitro diagnostic (IVD) devices for detecting Influenza A viruses in humans.

Recent public health concerns about the emergence of an avian Influenza A virus strain as a human pathogen in Southeast Asia spurred the agency to take action.

Several subtypes of Influenza A commonly circulate among birds and other animals, which have the ability to cause epidemics of varying intensity and severity.

The guidance offers recommendations for fulfilling labeling requirements applicable to all IVDs intended to detect the virus directly from human specimens, with 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 viruses, or to detect and differentiate a specific novel influenza A virus infecting humans. It also includes broad recommendations for assessing the clinical performance and utility of all such devices.

Sensitivity of any of these devices to detect influenza A depends on biological and pathophysiological factors associated with both the virus and its human host.

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