Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance Documents | NLM

Disaster Information Management Research Center | NLM

Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance Documents

06/15/2020 12:00 AM EDT

Source: U.S. Food and Drug Administration (FDA). Published: 6/15/2020. This web page answers questions about adverse event reporting for medical devices distributed under Emergency Use Authorizations (EUAs) or that are the subject of COVID-19-related guidance documents, and points out a number of adverse event reporting-related resources. (Text)