What is the difference between Emergency Use Authorization (EUA) and Food and Drug Administration (FDA) approval?
The FDA has the authority to grant Emergency Use Authorization (EUA) to diagnostic tests that have not yet received formal approval in times of a public health emergency. The FDA has granted EUA for certain tests during the COVID-19 pandemic to help detect or diagnose COVID-19.
Like full FDA approval, EUA relies on strict standards. However, EUA is completed more quickly based on the limited data that is available, unlike full FDA approval.