USA – FDA requirement updates for EUAs for diagnostics to support COVID-19 pandemic

This article discusses the evolution and implementation of the emergency use authorization (EUA) by the US Food and Drug Administration (FDA) for diagnostic devices during the COVID-19 pandemic in the United States. The author suggests that this limited oversight will affect future requirements for demonstrable superiority claims after the EUAs are terminated and diagnostics for the virus undergo increased scrutiny by the agency for marketing authorization. She covers the implications for the diagnosis and treatment of COVID-19 associated with variations in state and federal oversight, the authorization of diagnostics as it has evolved since late 2019, and their potential impact on future regulation of such devices. The scope of this article covers molecular diagnostics and antigen and serologic tests.

The FDA currently does not require premarket notification or authorization for validated tests developed by laboratories in order to meet immediate, emergent need for specific and highly sensitive tests. Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA commissioner has the authority to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency.1 This section of the FD&C Act has been amended on numerous occasions to align with prevailing public health needs.2-9 The 2013 amendment to the Pandemic and All-Hazards Preparedness Act of 2006, allows the commissioner to facilitate expedited reviews and issue EUAs for use of medical products for risks of public health emergencies involving chemical, biological, radiological, and nuclear (CBRN) and emerging infections disease agents…