Shuren: CDRH Writing Guidance To Explain What Should Happen To All Those EUA Tests, Devices
Executive Summary
Jeff Shuren, director of the US FDA’s device center, says the agency is drafting a guidance document that will give industry recommendations on how it should handle products granted emergency use authorization during the COVID-19 public health emergency, once it’s over. The guidance will also address already-approved devices that were modified by their makers under enforcement discretion.