FDA plays a critical role in protecting the United States (U.S.) from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.
FDA recognizes that it will take time for device1 manufacturers,2 healthcare facilities, healthcare providers, patients, consumers, and FDA to adjust from policies adopted and operations implemented during the declared COVID-19 public health emergency (PHE) to normal operations.3 To provide a clear policy for all stakeholders and FDA staff, the Agency is issuing this guidance to describe FDA’s general recommendations for this transition process with respect to devices issued Emergency Use Authorizations (EUAs) during the COVID-19 PHE, including recommendations regarding submitting a marketing submission, as applicable, and taking other actions with respect to these devices…
