Earlier this year, the U.S. Food and Drug Administration (FDA) published a final rule that reclassifies antigen-based Rapid Influenza Diagnostic Tests (RIDTs) from Class I to Class II and requires that these diagnostic devices meet increased sensitivity, specificity and annual strain testing quality controls. This reclassification becomes effective on January 12, 2018, which will have implications for laboratories during this upcoming influenza season (2017/2018).
This device reclassification was driven by concerns from the Centers for Disease Control and Prevention (CDC) about test sensitivity of RIDTs during the 2009 pandemic flu season. The goal of the reclassification is to improve the overall performance of RIDTs by requiring additional regulatory controls. These new measures should reduce the incidence of false-negative results, improving antibiotic stewardship across the continuum of care.
This webinar will review the FDA reclassification of RIDTs, discuss the new sensitivity and specificity requirements for RIDTs, and provide an overview of the products on the market that meet the new requirements. Also covered in the webinar will be information on how long products not meeting the new requirements can be sold by distributors and manufacturers, as well as the date up until which laboratories may use such diagnostic devices. This webinar is intended to help enable laboratories to prepare for the changes and minimize any impacts to established influenza protocols.