Mutations, Pandemic Prompt FDA Proposal To Up-Classify Rapid Influenza Tests
This article was originally published in The Gray Sheet
Executive Summary
FDA’s experiences during the 2009 influenza virus epidemic, the potential lethality of influenza, and the propensity of the virus to mutate prompts a May 21 proposal that flu tests be regulated under class II with special controls, up from the current class 1 designation.