FDA Updated Its eMDR System. Here’s What You Need To Know When Submitting Adverse Events
The US agency has completed planned modifications to its electronic Medical Device Reporting system – and added an extra field for MDR exemption numbers.
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The addition of the question “Was this device serviced by a third party servicer?” to adverse event reports filed through the US FDA’s electronic Medical Device Reporting system could prove helpful for the agency and device makers, experts tell Medtech Insight. Industry has long complained about poor work performed by servicers – and loudly groused that they’re not regulated.
The International Medical Device Regulators Forum, perhaps most notorious for its efforts to standardize audit processes between nations with its Medical Device Single Audit Program, is also focusing on harmonizing device reviews and adverse event codes.
An update by the US agency to its MedWatch 3500A adverse event reporting form targets summarized events and patient gender. The FDA is also updating its electronic Medical Device Reporting (eMDR) system to accommodate the changes made to the 3500A, among other revisions.