This guidance is intended to answer questions related to FDA’s final rule requiring device manufacturers and importers to submit mandatory reports of individual medical device adverse events, also known as medical device reports (MDRs), to the Agency in an electronic format that FDA can process, review, and archive (hereinafter referred to as the eMDR Final Rule). Electronic reporting is also available to user facilities, however, the eMDR Final Rule permits user facilities to continue to submit only written reports to FDA. The requirements of this final rule will take effect on August 14, 2015. This guidance provides general information regarding how to prepare and send an electronic postmarket medical device report to the Center for Devices and Radiological Health (CDRH) in FDA. The guidance also identifies where you can find more detailed information on the preparation and transmission of the reports.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.