Guidance Documents (Medical Devices and Radiation-Emitting Products) > Questions and Answers about eMDR - Electronic Medical Device Reporting - Guidance for Industry, User Facilities and FDA Staff

Guidance Documents (Medical Devices and Radiation-Emitting Products) > Questions and Answers about eMDR - Electronic Medical Device Reporting - Guidance for Industry, User Facilities and FDA Staff

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).  To view the guidance, please see: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm175805.htm