FDA’s New Reclassification of Rapid Influenza Diagnostic Tests: Are you Prepared?

Cardinal Health Lab Briefings webinar series

This webinar is presented by Gregory J. Berry, Ph.D., D(ABMM), Assistant Professor of Pathology and Laboratory Medicine at Hofstra Northwell School of Medicine


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.



Upon completion of this continuing education activity, the participant should be able to:

  1. Review FDA influenza reclassification requirements and assess impact to currently utilized RIDTs.
  2. Identify the different types of influenza tests available and if they are compliant with the new FDA guidelines.
  3. Understand the pros and cons of each type of influenza testing based on the needs of your laboratory.
  4. Explain the dates until which products not meeting the new guidelines can be sold, as well as how long they can be used for patient testing.
  5. Describe impacts to flu testing protocols in the 2017/2018 season as well as the 2018/2019 seasons and beyond.


Intended audience

This continuing education credit is intended for use by clinical laboratory professionals who are interested in learning more about the FDA influenza reclassification and how they can prepare for the changes and minimize any impacts to established influenza protocols.


Take the course and obtain CE credits

Attend this basic level webinars at no cost. This webinar is managed by Whitehat Communications and offer one P.A.C.E.® Continuing Education contact hour1 for up to six months after the live event.

One P.A.C.E® credit is available upon completion of the course: FDA’s New Reclassification of Rapid Influenza Diagnostic Tests: Are you Prepared?

P.A.C.E.® credits are widely recognized in the clinical laboratory profession and can be used to fulfill most continuing education requirements.

1 Whitehat Communications is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program.