Bernard Jee, Product Manager, Pilgrim Quality Solutions
As part of the enhancement to the electronic Medical Device Reporting (eMDR) system, the U.S. Food and Drug Administration (FDA) has indicated in its initial 2017 announcement that there will be an update to the Adverse Events codes. In particular, the code sets used in eMDR fields F10 and H6 are being harmonized with the International Medical Device Regulators Forum (IMDRF) Adverse Events Reporting terminologies, a new international guideline for coding medical device adverse events.
Based on conversation with the FDA and National Institutes of Health (NIH), the update is scheduled for implementation on April 6, 2018. An initial rollout in the pre-production environment will take place prior to April 6, 2018, allowing submitters a chance to conduct testing of their submission process to determine if any changes are required to accommodate these new codes.
At this point, the update is only for FDA and National Cancer Institute thesaurus (NCIt) codes. A plan will be established for the FDA to start accepting IMDRF codes for eMDR submissions, however, a date has not be determined. This means that the FDA will continue to accept FDA and NCIt codes that are not retired as part of this initial update. The FDA has published a guidance on how to handle codes that have been retired.
This link also contains a 1-to-1 mapping between FDA, NCIt, and IMDRF codes. Stay tuned as the FDA provides further time sensitive updates.
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