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Medical Devices / Regulatory Affairs / Postmarket Safety

FDA Adverse Event Codes Harmonization Will Ease Burden, Expert says

Dec. 29, 2017

FDA medical device adverse event codes will soon be harmonized with IMDRF terminology — a move that is expected to benefit not just regulatory bodies, but also device firms and consumers.

The FDA recently provided details on the changes planned for certain adverse event codes, among other updates, with a spring 2018 deployment of CDRH’s eMDR system along with the eSubmitter software for preparing submissions. The agency is encouraging firms to begin preparing as soon as possible because the retired codes will be rejected by the updated system.

The coding harmonization will reduce the burden on device firms to keep track of all the codes across different regulatory bodies, Bernard Jee, product manager at software company Pilgrim Quality Solutions, which contributed to the creation of eSubmitter, told FDAnews.

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