Advancing EUA IVD Products Toward Full Marketing Status
FDA White Oak Campus 10903 New Hampshire Ave, Silver Spring, MD, United StatesThe Medical Device Innovation Consortium (MDIC) will host a workshop on 3 Feb 2020 to explore key considerations for using real world data to help support in vitro diagnostic (IVD) products available under FDA’s emergency use authorization (EUA) to advance to full marketing status. A roadmap for diagnostic evaluations during emergencies would help enable stakeholders