FDA Proposes to Tighten Controls on Some Flu Test Devices

The Food and Drug Administration is proposing to reclassify rapid influenza detection test systems from class I to class II. The reclassification would apply to antigen-based rapid influenza virus antigen detection test systems used to detect influenza virus directly from clinical specimens that are currently regulated as influenza virus serological reagents. It would make the test systems subject to premarket notification, and would designate special controls the agency deemed necessary for safe use. FDA would also change the name of the products to "influenza virus antigen detection test systems.” Comments on the reclassification are due by Aug. 7.