This announcement is being broadcast to inform all stakeholders of an upcoming change to the FDA Adverse Event Coding System (used in sections F10 and H6 of 3500A MDR reports), and the corresponding update to CDRH’s Electronic Medical Device Reporting (eMDR) system.
On April 6, 2018, the FDA’s Device Problem Code, Manufacturer Evaluation Method Code, Manufacturer Evaluation Result Code, and Manufacturer Evaluation Conclusion Code hierarchies will be updated to harmonize with the IMDRF Adverse Event Reporting Terminologies. These FDA codes correspond to IMDRF Annexes A through D, which are posted online at (http://imdrf.org/documents/
documents.asp#imdrf). A future update will harmonize all remaining FDA adverse event codes with IMDRF, once the remaining IMDRF Annexes are published. IMDRF codes are not currently accepted by eMDR, but the new hierarchies posted on FDA.gov include a one-to-one mapping of IMDRF codes to FDA codes.
FDA codes that are being retired will be rejected by eMDR once this update is deployed. The FDA is also providing a set of disposition files, which explain what to do if a previously-used code has been retired. eSubmitter will update concurrently with eMDR, but AS2 submitters should begin preparing to update the codes used in their HL7 ICSR XML applications on April 6, 2018 as soon as possible.
This information will also be posted to the eMDR System Enhancements page on FDA.gov at https://www.fda.gov/
MedicalDevices/ DeviceRegulationandGuidance/ PostmarketRequirements/ ReportingAdverseEvents/eMDR– ElectronicMedicalDeviceReporti ng/ucm475303.htm. Please go to the eMDR website for links to the relevant adverse event code resource files.