FDA Announces New eMDR System Enhancements: What Medical Device Manufacturers Should Know
The FDA has announced new eMDR system enhancements, including AEMS integration updates, country code validation changes, and IMDRF adverse event code updates impacting medical device manufacturers.
FDA Updates eMDR Framework with ESG NextGen Submission Portal
The FDA has replaced the WebTrader system with the ESG NextGen portal for eMDR submissions. Learn what this means for medical device manufacturers and reporting obligations under 21 CFR Part 803.
IMDRF Publishes Final Guidance on the Selection of Adverse Event Terminology
IMDRF publishes final guidance on the selection and consistent use of adverse event terminology (AET) codes for medical devices and IVDs.