MDR Adverse Event Code Harmonization

On April 6, 2018, FDA updated codes for MDR reporting. The updated code hierarchies are: Device Problem Code, Manufacturer Evaluation Method Code, Manufacturer Evaluation Result Code, and Manufacturer Evaluation Conclusion Code.

The update harmonizes the codes with the IMDRF Adverse Event Reporting Terminologies. The FDA codes correspond to IMDRF Annexes A through D, available from

FDA plans to harmonize all remaining FDA adverse event codes with the IMDRF codes as they become available.

The eMDR system rejects retired codes.

FDA has updated eSubmitter for the new codes.