FDA Releases Post-COVID Guidance on Medical Devices

The FDA issued two guidance documents to help prepare medical device manufacturers, distributors, healthcare facilities and providers, and other stakeholders through the expiration of the COVID-19 Public Health Emergency (PHE). The two guidance documents are: “Transition Plan for Medical Devices that Fall Within Enforcement Policies Issued During the COVID-19 Public Health Emergency” and “Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUA) Related to COVID-19.” FDA will host a webinar on April 18 at 1:00 – 2:30 pm ET to help prepare stakeholders for an orderly transition. Access the webinar.