Bernard Jee, Product Manager, Pilgrim Quality Solutions, an IQVIA company
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.