FDA Officials Call For Lab Test Bill In COVID-19 Lessons Learned Report

Top FDA device center officials call for the United States to create a legislative framework for overseeing lab tests and to work with global partners to devise a plan for sharing clinical specimens to ensure diagnostic testing is accurate and reliable in future pandemics. The recommendations come as the agency reflects on its missteps in mitigating the COVID-19 health crisis and acknowledges its emergency authorization process, coupled with inexperienced test developers, led to mass confusion and poorly developed laboratory tests...