Respiratory Infection

On May 15, 2012, the U.S. Food and Drug Administration (“FDA”) announced the clearance of expanded uses for the FilmArray Respiratory Panel, a medical device used to detect causes of respiratory infection. Manufactured by Idaho Technology, Inc., the device is cleared for the simultaneous detection of both viral and bacterial causes of respiratory infection. The device was originally cleared by the FDA in 2011 to detect only viral causes of respiratory infection. Now, with the expanded panel, the device is cleared to concurrently detect 17 viruses and three bacteria. The FDA’s regulation of medical devices follows a three-tier approach. Class…