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 devicemakers and consumers.
The FDA recently provided details of planned changes for certain adverse event codes, among other updates, for the anticipated 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 remaining codes will eventually be harmonized with the terminology developed through IMDRF — the international consortium involving regulatory bodies in the U.S., Australia, Brazil, Canada, China, Europe, Japan, Russia, Singapore, and latest member country Korea aimed at harmonizing medical device regulations (IDDM, Dec. 18, 2017).
The coding harmonization will reduce the burden on device firms of keeping 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.
It will likely be “especially helpful for smaller firms that do not have the specific resources for regulatory bodies to accurately report on their adverse events….as the management of problem codes across multiple regulatory bodies can be time consuming,” he said.