March 19, 2020

FDA Allows Commercial Manufacturers to Distribute Unapproved COVID-19 Tests During Public Health Emergency

On Monday, March 16, 2020, the FDA issued guidance to allow for acceleration of the availability of diagnostic tests used to detect Coronavirus Disease-2019 (COVID-19). The guidance, implemented without prior public comment, allows commercial manufacturers to develop and distribute COVID-19 diagnostic tests to clinical laboratories and healthcare workers. A manufacturer may make this distribution after validating the test and while the manufacturer is preparing an Emergency Use Authorization (EUA) request. Manufacturers should notify FDA after validating the test, at which point FDA will allow roughly fifteen business days for preparation of the EUA. FDA will then review the EUA, work with the manufacturer to resolve identified problems, and require recalls and suspension only where significant problems cannot be timely addressed.