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Medical Devices / Regulatory Affairs / Postmarket Safety / Submissions and Approvals

FDA to Harmonize Adverse Event Codes With IMDRF Terminology

Dec. 19, 2017
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FDA Adverse Event Codes will be updated with a spring 2018 deployment of CDRH’s electronic medical device reporting system and its eSubmitter software, the agency announced.

The changes to the codes used in eMDR reports for a Device Problem, Manufacturer Evaluation Method, Manufacturer Evaluation Result, and Manufacturer Evaluation Conclusion will be harmonized with adverse event reporting terminologies used by IMDRF — the global initiative involving regulatory bodies in the U.S., Australia, Brazil, Canada, China, Europe, Japan, Russia, and Singapore aimed at harmonizing medical device regulations.

eMDR deployment is currently set for Apr. 6, 2018. Earlier this year, the agency posted a notice about its plans to release version 3.0 of its eSubmitter software, which transmits the submitted files to the FDA gateway, this November but later changed the release date to December.

The FDA encouraged stakeholders to “begin preparing to update the codes used in their HL7 ICSR XML applications…as soon as possible” because the codes being retired “will be rejected by eMDR once this update is deployed.”

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