In June 2013, the FDA proposed the reclassification of Rapid Influenza Diagnostic Tests (RIDTs) from Class I to Class II. (a product has a Class II classification meaning that it has “special controls” which for Flu kits means they must meet minimum performance standards in detecting a Flu A and Flu B virus). The FDA placed notice of this proposed change in the Federal Register on May 22, 2014 and received public commentary. This proposed change was driven by CDC concerns about the performance of these rapid influenza detection tests during the 2009 pandemic flu season.
The FDA published the final order in the Federal Register on January 12, 2017.
The goal of the reclassification is to improve performance of these test kits as compared to a reference method (viral culture or nucleic acid-based) as well as testing of annually forecasted circulating strains. The new guidelines and controls have been created to reduce the percentage of false positive results which will help drive antibiotic stewardship across the continuum of care.
Here are some of the frequently asked questions and important dates to be aware of: