Federal Register Notice: FDA is making available a guidance, In Vitro Diagnostic Devices to Detect Influenza A Viruses: Labeling and Regulatory Path, to inform industry and agency staff of steps needed to ensure the safe and effective use of in vitro diagnostic devices intended for detecting influenza A (or A/B) virus directly from human specimens. The agency is taking this action because of recent public health concerns over the emergence of an avian influenza A virus strain as a human pathogen in Southeast Asia. This guidance gives recommendations for fulfilling labeling requirements and outlines the premarket regulatory path for new or modified devices intended to generally detect influenza A virus, or to detect and differentiate, specific novel influenza A viruses infecting humans. To download the guidance, click here. To view this notice, click here.