Devices Available Under EUA Can Stay On Market Pending FDA Review

Medical devices currently on the market under emergency use authorization can stay on the market after the COVID-19 EUA declaration expires, as long as the manufacturers have already submitted an application for full clearance or approval to FDA, and the agency has accepted the application, FDA says in a final guidance published Friday (March 24). FDA does expect manufacturers to stop distributing devices when the EUA declaration ends if they have not submitted a marketing application to the agency or...