In a declared emergency, like a pandemic, if a device, drug, or test may show benefits for patients, the FDA can issue an emergency use authorization (EUA). An EUA allows the FDA to authorize a product, treatment, or device quickly and without going through a full, rigorous, and complete review process.
One of the minimum requirements for issuing an EUA for a product or treatment is that the known and potential benefits outweigh the known potential risks. Typically, prior to approving an EUA, the FDA needs a good reason to issue the authorization, such as the product, drug, or test meets a reasonable threshold for safety and effectiveness, and people are in urgent need of care.
It is important to note that the FDA’s approval for an EUA does not constitute full statutory approval but instead authorizes the FDA to facilitate the availability of an unapproved product or an unapproved use of an approved product during a declared state of emergency. Compared to full FDA approval, the FDA can withdraw an EUA at any time, preventing a company from selling or dispensing its product or services. On the other hand, with full FDA approval, it can take several years for the FDA to rescind approval.
On February 4, 2020, the Secretary of the U.S. Department of Health and Human Services (HHS) declared a public health emergency for the SARS-CoV-2 virus that causes COVID-19 disease. This allowed the FDA to issue an EUA for certain medical devices involved in the diagnosis of COVID-19. In February 2020, the FDA began issuing an EUA for COVID-19 testing kits. Effective March 27, 2020, the HHS also allowed for EUA approval for the use of certain drugs and biological therapeutic products during the COVID-19 pandemic. Subsequently, in December 2020, the FDA granted EUA approval for both the Pfizer-BioNTech and Moderna vaccines.
The FDA has given EUA approvals to hundreds of commercial COVID-19 tests, including immunoassays and molecular assays. The following sources and links provide updated lists of the various FDA EUA-approved COVID-19 tests:
