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.
FDA Clarifies eCopy Requirements as eSTAR Becomes the New Standard for Device Submissions
The FDA has released updated draft guidance on the eCopy Program, clarifying current requirements for electronic device submissions. As eSTAR becomes the new standard, understanding when eCopy rules still apply is critical for medical device manufacturers.