During a public health emergency, the Food and Drug Administration (FDA) can use its Emergency Use Authorization (EUA) authority to allow the use of unapproved medical products or the unapproved uses of approved medical products to diagnose, treat, or prevent serious or life-threatening diseases. This is only permittable when certain criteria are met, including when there are no adequate, approved, and available alternatives. This process allows for laboratories to develop and perform EUA testing rapidly in response to the related emergency.
Previous EUA examples include those for Ebola virus, Zika virus, and Enterovirus D68. In early 2020, COVID-19 also obtained an EUA status from the FDA.
All SARS-CoV-2 / COVID-19 testing must follow all package insert instructions and EUA requirements.
