FDA Announces New EUA Template for At-Home and Over-the-Counter SARS-CoV-2 Diagnostic Tests

FDA maze of regulations

FDA guidance provides pathway for developers and manufacturers to obtain EUAs for at-home and over-the-counter COVID-19 testing. The US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) template for test developers attempting to create at-home and over-the-counter SARS-CoV-2 diagnostic tests. The FDA announced this new template in a press release July 29, 2020, providing […]