FDA Updates Information on How to Submit Medical Device Reports for Devices Marketed Under Emergency Use Authorizations or within the Scope of Certain Enforcement Policy Guidance

The U.S. Food and Drug Administration (FDA) would like to make you aware of updated information on our website regarding the process for submitting Medical Device Reports (MDRs) for adverse events related to devices under EUA or following an Enforcement Policy Guidance for a COVID-19-related medical device.

Specifically, the FDA has updated the FAQs entitled Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance Documents. These FAQs explain how a manufacturer distributing medical devices under an EUA or following a COVID-19-related Enforcement Policy guidance document that has not completed Registration and Listing can sign up for an electronic Medical Device Reporting (eMDR) account using an FDA Establishment Identifier (FEI) number and submit MDRs electronically. The FAQs also include general information on how to submit adverse event reports for these devices.

Read the FAQs

Questions?

If you have any questions about this submission process or other topics involving adverse event reporting for devices under EUA, you may email CDRH at COVID19-DeviceReporting@fda.hhs.gov.