FDA Harmonizes Adverse Event Reporting System with International Codes
The FDA has updated its electronic medical device reporting (eMDR) system to include new fields for summary reports and combination products to harmonize with international reporting codes.
The changes include adverse event codes and terminologies outlined by the International Medical Device Regulators Forum (IMDRF).
All FDA code sets have been renamed to their IMDRF names, and IMDRF codes will now be accepted by the eMDR system in addition to the corresponding FDA and National Cancer Institute codes.
The FDA said that eMDR will stop accepting the retired codes on Nov. 28. The system is already accepting the updated codes, and the changes will go into full effect in February 2021.