FDA takes steps to streamline path for COVID-19 screening tools, provides information to help groups establishing testing programs
SILVER SPRING, Md., March 16, 2021 -- Testing remains an important cornerstone of our nation's fight against COVID-19. This includes schools, workplaces, communities and other locations using testing to screen asymptomatic individuals who may still spread the virus. Screening involves testing asymptomatic individuals who do not have known or suspected exposure to COVID-19 in order to make individual decisions, such as whether an individual should participate in an activity, based on the test results. Today, we are providing information for test developers about a streamlined path to emergency use authorization for these important screening tools as well as information to help these groups as they set up testing programs. Our actions complement those taken by the Centers for Disease Control and Prevention (CDC) and are not intended to replace CDC's testing or other public health guidance. First, the FDA issued a new supplemental template for test developers seeking emergency...