Client Alert: FDA Taking Overdue Steps to Accelerate COVID-19 Diagnostic Testing

In response to the COVID-19 pandemic, and in light of the persistent shortage of diagnostic tests for the SARS-CoV-2 virus, the U.S. Food and Drug Administration (FDA) provided recent but overdue guidance on the use of its Emergency Use Authorization (EUA) authority and has taken additional steps to liberalize its oversight of clinical laboratory diagnostic testing tor the SARS-CoV-2 virus.

Under section 564 of the Federal Food, Drug, and Cosmetic Act (FFDCA, 21 U.S.C. 360bbb-3), the FDA may authorize “emergency use” of unapproved products or unapproved uses of approved products to diagnose, treat, or prevent serious or life-threatening diseases or conditions when there are no adequate, approved, and available alternatives. An Emergency Use Authorization (EUA) is possible only upon an emergency declaration or a threat justifying emergency authorized use, such as “heightened risk of attack with a biological, chemical, radiological, or nuclear agent or agents” or, in the present case, “a public health emergency… that involves a biological, chemical, radiological, or nuclear agent or agents...