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Coronavirus (COVID-19) Update: FDA Issues New Policy to Help Expedite Availability of Diagnostics

SILVER SPRING, Md., Feb. 29, 2020 /PRNewswire/ --A Today, as part of the U.S. Food and Drug Administration's ongoing and aggressive commitment to address the coronavirus outbreak, the agency issued a new policy for certain laboratories seeking to develop diagnostic tests for coronavirus in order to achieve more rapid testing capacity in the U.S."We believe this policy strikes the right balance during this public health emergency," said FDA Commissioner Stephen M. Hahn, M.D. "We will continue to help to ensure sound science prior to clinical testing and follow-up with the critical independent review from the FDA, while quickly expanding testing capabilities in the U.S. We are not changing our standards for issuing Emergency Use Authorizations. This action today reflects our public health commitment to addressing critical public health needs and rapidly responding and adapting to this dynamic and evolving situation."There is currently an outbreak of respiratory disease caused by a novel coronavirus that was first detected in Wuhan City, Hubei Province, China and which has now been detected in 50 locations internationally, including cases in the United States. The virus has been named "SARS-CoV2" and the disease it causes has been named "Coronavirus Disease 2019" (COVID-19). SARS-CoV-2 has demonstrated the capability to rapidly spread, leading to significant impact on health care systems and causing societal disruption. The potential public health threat posed by COVID-19 is high, both globally and to the U.S. To effectively respond to the COVID-19 outbreak, rapid detection of cases and contacts, appropriate clinical management and infection control, and implementation of community mitigation efforts are critical. This can best be achieved with wide availability of testing capabilities in health care settings, reference and commercial laboratories, and at the point of care. The new policy is for certain laboratories that develop and begin to use validated COVID-19 diagnostics before the FDA has completed review of their Emergency Use Authorization (EUA) requests. The FDA can issue an EUA to permit the use, based on scientific data, of certain medical products that may be effective in diagnosing, treating or preventing a disease or condition when there is a determination, by the Secretary of Health and Human Services (HHS), that there is a public health emergency or a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens, and a declaration that circumstances exist justifying the medical products' emergency use. On Feb. 4, 2020, the Secretary of HHS determined that there is a public health emergency and that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the COVID-19 outbreak. Rapid detection of COVID-19 cases in the U.S. requires wide availability of diagnostic testing to control the emergence of a rapidly spreading, severe illness. The FDA has authorized one EUA for COVID-19 that is in use by the U.S. Centers for Disease Control and Prevention (CDC) and some public health labs across the country.
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