FDA Post-Pandemic Plan for Medical Devices Now Marketed Under Special COVID Rules

Healthcare attorneys Michael Werner and Sara Klock will host a webinar about future regulations for medical devices. The U.S. Food and Drug Administration (FDA) recently announced its plan to provide medical device manufacturers 180 days to secure marketing authorization or clearance for medical devices that have been marketed under special rules during the COVID-19 pandemic. During the COVID-19 pandemic FDA has used two vehicles – enforcement policies and emergency use authorizations – to allow certain otherwise unapproved or unauthorized devices to be lawfully marketed provided that manufacturers complied with requisite rules. FDA has released two draft guidances regarding transitioning products brought to market during the COVID-19 Public Health Emergency. This webinar will provide an overview of FDA's draft guidances and provide operational advice to manufacturers operating in the space.