As part of FDA’s ongoing and aggressive commitment to address the global coronavirus outbreak, the agency recently issued a new policy for certain laboratories seeking to develop diagnostic tests for coronavirus in order to achieve more rapid testing capacity in the United States.1
“We believe this policy strikes the right balance during this public health emergency,” says FDA Commissioner Stephen M. Hahn, MD. “We will continue to help to ensure sound science prior to clinical testing and follow-up with the critical independent review from FDA, while quickly expanding testing capabilities in the United States. 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.”
Stephen M. Hahn, MD, FDA.
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 spread rapidly, leading to significant impact on healthcare systems and causing societal disruption. The potential public health threat posed by COVID-19 is high, both globally and to the United States. 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 healthcare 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 FDA has completed review of their emergency use authorization (EUA) requests. 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 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 US citizens, and a declaration that circumstances exist justifying the medical products’ emergency use.
For further information, visit FDA.
Reference
1. Policy for Diagnostics Testing in Laboratories Certified to Perform High-Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency: Immediately in Effect Guidance for Clinical Laboratories and Food and Drug Administration Staff. Silver Spring, Md: Office of Medical Products and Tobacco, Center for Devices and Radiological Health, FDA, 2019. Available at: www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-diagnostics-testing-laboratories-certified-perform-high-complexity-testing-under-clia-prior. Accessed March 3, 2020.
