FDA Releases Plan For Enhancing eMDR Adverse Event Reporting System
The US agency has announced some changes it plans to make to its electronic Medical Device Reporting system over the coming year.
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The US FDA has updated its electronic Medical Device Reporting system to accept adverse event codes devised by the International Medical Device Regulators Forum. The agency is urging reporters using an AS2 submission account to “update their systems as soon as possible.”
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