Medical device manufacturers and importers are required to report “adverse events” to FDA when their device has caused or contributed to death or serious injury. An adverse event is when a device has a malfunction that could cause death or serious injury. Importers report this information to the manufacturer. The FDA has announced that it will update certain codes used for Adverse Event Reporting through the Electronic Medical Device Reporting (eMDR) system on April 6, 2018.
The Agency will replace the codes for FDA Device Problem, Manufacturer Evaluation Method, Manufacturer Evaluation Result, and Manufacturer Evaluation Conclusion with similar codes established by the International Medical Device Regulators Forum (IMDRF).