NEW YORK (360Dx) – The US Food and Drug Administration is reclassifying some antigen-based test systems for detecting influenza from a class I device to a class II device with special controls.
The reclassification, which takes effect on Feb. 13, covers antigen-based influenza virus antigen detection test systems for detecting influenza virus directly from clinical specimens that are currently regulated as influenza virus serological reagents. FDA also is reclassifying the devices into a new device classification regulation, it said in a final order filed with the Federal Register on Thursday.
Class I medical devices are considered as low risk and are the least regulated devices by the FDA. Class II devices are higher risk than class I devices, and their makers must provide information that the products are safe and effective. Class III devices are the highest-risk devices and have the highest regulatory threshold to meet in order to be approved by the FDA.
The FDA had originally proposed changing the classification of antigen-based rapid influenza diagnostic tests, or RIDTs, in February 2014. In the interim it held a meeting of a device classification panel and received and considered comments on the proposal. According to the FDA, commenters generally supported the proposed reclassification, and some noted that evidence suggests that antigen-based RIDTs, which are widely used in non-clinical lab settings, have performed poorly, resulting in "many misdiagnosed cases of influenza."
The general opinion among commenters, FDA said, is that the reclassification of such tests would "mitigate" health risks, and the change is "expected to lower the number of misdiagnosed influenza infections by increasing the number of devices that can reliably detect the influenza virus."
The FDA said that special controls will identify the minimal acceptable performance criteria; require the use of appropriate and accepted FDA comparator methods for establishing the performance of new antigen-based RIDTs; require yearly analytical reactivity testing of contemporary influenza strains; and require analytical reactivity testing of new emerging strains under certain situations involving an emergency or potential emergency. The special controls are needed to ensure the safety and effectiveness of the devices, the agency added.
It and the US Centers for Disease Control and Prevention will collaborate to ensure that an influenza virus analytical reactivity test panel will be available to all manufacturers of such tests to evaluate their assays.