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Food and Drug Administration
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Comments of Members of the Patient, Consumer, and Public Health Coalition
on the Proposed Order
Microbiology Devices; Reclassification of Influenza Virus Antigen Detection Test Systems
Intended for Use Directly With Clinical Specimens
[Docket No. FDA-2014-N-0440]
Members of the Patient, Consumer, and Public Health Coalition strongly support the up-classification of influenza detection devices. We support moving the devices from class I to class II with special controls and into a new device classification regulation (from 21 CFR 866.3330 to 21 CFR 866.3328). We agree with the FDA that “the accuracy of these devices has serious public health implications,” since influenza can cause serious illness and death.
Many of the rapid influenza antigen detection tests or RIDTs (also referred to as antigen tests) that were cleared since 1998 have had performance problems (good specificity but low sensitivity). The 2009 flu pandemic underscored that RIDTs “performed poorly resulting in misdiagnosed cases.”1
On June 13, 2013, the Microbiology Advisory Panel met to discuss performance problems with RIDT systems. The panel noted that “poor sensitivity of RIDTs has always been a concern,”2 and they raised concerns that influenza viruses mutate quickly. Fast changing viruses “may cause the functional components of influenza diagnostic devices not to recognize current influenza strains,” which will lead the devices to provide inaccurate results.2
Panel members indicated that putting RIDTs into Class II with special controls was needed to mitigate the risks of false positive and false negative results. We strongly agree.
In the past, FDA has cleared these less-than-effective RIDT devices as class I 510(k) devices. This allowed the devices to be used as predicates for new 510(k) submissions, which “promotes further clearance of devices that do not meet the needed performance for detection and management of infection by novel strains of influenza.”2 Reclassifying RIDTs as class II will better ensure that ineffective devices are no longer cleared on an ineffective class I RIDT predicate. Devices that were cleared as class I RIDTs will have to meet the class II special controls to remain on the market, which will better protect patients and public health.
We agree with FDA’s proposed order that RIDTs regulated under 21 CFR 866.3330 be reclassified into Class II with special controls under the new device name “influenza virus antigen detection tests system”(21 CFR 866.3328). Section 866.3328 specifically states, “Because influenza is highly contagious and may lead to an acute respiratory tract infection causing severe illness and even death, the accuracy of these devices has serious public health implications.”1 The regulation also lists precise special controls for these devices including sensitivity and specificity performance characteristics.
The early diagnosis of influenza can reduce the inappropriate use of antibiotics. In contrast, the failure of the device to perform accurately could harm patients. For example, a false negative could result in a dangerous delay in treatment, or could result in spreading the flu in families and communities as well as vulnerable settings such as hospitals, retirement communities, and nursing homes. A false positive could lead to unnecessarily isolating a patient or a delay in treating respiratory infections caused by something else besides the flu.
Due to the widespread use of RIDTs—and their current lack of accuracy—we strongly support the FDA’s proposed order to up-classify the devices from class I to class II with special controls. More stringent requirements for influenza diagnostic devices would assist health care professionals in accurately diagnosing patients, and help public health officials better respond to influenza outbreaks. Because flu viruses can make people severely ill or lead to death, RIDTs must be as accurate as possible, and up-classification with specific special controls is urgently needed to protect patients and the public health.
American Medical Women’s Association
Annie Appleseed Project
Center for Medical Consumers
Connecticut Center for Patient Safety
National Center for Health Research
National Consumers League
National Organization for Women
National Women’s Health Network
The Patient, Consumer, and Public Health Coalition can be reached through Paul Brown at (202) 223-4000 or at firstname.lastname@example.org
 Federal Register (May 22, 2014). Food and Drug Administration Proposed order: Microbiology Devices; Reclassification of Influenza Virus Antigen Detection Test Systems Intended for Use Directly With Clinical Specimens.
 Food and Drug Administration, CDRH Microbiology Devices Advisory Committee Meeting (June 13, 2013). Executive Summary: Proposed Reclassification of the Rapid Influenza Detection Tests.