FDA Issues EUA Template For At-Home COVID-19 Sample Collection Kits

FDA on Friday (May 29) published a voluntary Emergency Use Authorization template for COVID-19 at-home sample collection kits . The template details what data and information clinical laboratories and commercial diagnostic test makers should submit to support EUA submission for home collection devices that patients can use to collect clinical specimens, such as nasal or saliva swabs, to test for SARS-CoV-2, the virus that causes COVID-19. The template does not cover non-prescription home collection devices or over-the-counter COVID-19 tests, FDA...