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Rapid Influenza Diagnostic Tests (RIDT’s) Reclassification 2018

The Food and Drug Administration (FDA) has announced the reclassification of rapid influenza antigen detection tests (RIDTs). Tests that do not meet these new standards will not be available for purchase after January 12, 2018.

On January 12, 2017, the FDA notified the public of its decision to reclassify antigen-based rapid influenza detection test systems (RIDTs). The Food and Drug Administration (FDA) is reclassifying antigen based rapid influenza virus antigen detection test systems intended to detect influenza virus directly from clinical specimens that are currently regulated as influenza virus serological reagents from class I into class II with special controls and into a new device classification regulation.

Read the FDA ruling

Information About Changes to Influenza Testing

VIDEO WEBINAR - Meeting the Standards - The Impact of Rapid Flu Test Reclassification. A comprehensive walk through on the scope and reasons for the reclassification, special controls, the implementation date and implications of RIDT reclassification to healthcare providers, manufacturers and distributors. Hosted by Sekisui Diagnostics.

AAP - American Academy of Pediatrics Response to the FDA Reclassification. The American Academy of Pediatrics outlines four risks of Rapid Influenza Diagnostic Tests (RIDTs) as the basis of their support for the FDA Flu Reclassification.

Resources for Your Practice

Medical Devices That Meet the New Requirements Information Sheet. Overview of both Reader and Molecular influenza testing devices that comply with the new FDA requirements.