 
Today, the U.S. Food and Drug Administration (FDA) granted marketing authorization of the Sofia 2 SARS Antigen+ FIA, Sofia SARS Antigen FIA Control Swab Set, intended for prescription use only for the detection of the COVID-19 virus within 6 days of symptom onset and which can be used in a point-of-care setting. The test aids in the diagnosis of COVID-19 for people experiencing symptoms and is to be repeated twice over three days with at least 48 hours between tests.
“Today’s marketing authorization of the first COVID-19 antigen test underscores our ongoing commitment to maintain access to testing long-term,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “We look forward to working with developers of all test types who are interested in moving their products through our traditional review pathways and encourage those who are ready to do so as soon as possible. We remain committed to ensuring the public has access to accurate and reliable tests they can count on.”
Along with this De Novo authorization, the FDA is establishing criteria called special controls that define certain requirements including required labeling and performance testing. When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type. This action also creates a new, Class II regulatory classification for simple devices to directly detect SARS-CoV-2 viral targets from clinical specimens in point-of-care settings or at home use, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) pathway, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device.
The granting of this De Novo request for Quidel’s Sofia 2 SARS Antigen+ FIA, Sofia SARS Antigen FIA Control Swab Set, is the latest example of the FDA’s commitment to ensure ongoing access and availability of COVID-19 diagnostic tests.
Questions?
If you have questions about this announcement, contact the Division of Industry and Consumer Education.
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