By Marilyn Gatin, Min Yao, Dorothy Henckel, Jane SC Tsai
When a new virus like SARS-CoV-2 arises and causes widespread disease, death, and economic devastation as COVID-19, part of the public health threat is that testing for it doesn’t yet exist. Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) allows for testing to be developed and authorized very rapidly, within weeks, compared with non-emergency pathways that can take months or years. With the public’s health in danger, the FDA’s program adjusts the regulatory requirements to facilitate the availability of diagnostic testing and to expand testing capabilities during the declared emergency.
An EUA is not an FDA approval and only applies for as long as the public health emergency is in effect. Additional data to prove safety and effectiveness are required for approval or clearance of the test in transition to full marketing status.
Any entity seeking EUA is advised to speed development by direct advisement from the FDA via email to CDRH-EUA-Templates@fda.hhs.gov. For industry questions, companies can contact a hotline 1-888-INFO-FDA, choose option *, or email to firstname.lastname@example.org. Information is updated regularly on FDA websites, including COVID-19 Diagnostics FAQ and EUAs granted.