Second Set of Frequently Asked Questions about EUDAMED: Scope
During our recent EUDAMED webinar there were a tremendous number of questions. For your convenience, we’ve compiled the second set of questions in a Q&A format. This focuses on scope.
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US FDA Updates to eSTAR (version 7.0) and preSTAR (version 3.0)
On June 1, 2026, the FDA released new major version for both eSTAR templates (version 7.0) and the PreSTAR template (version 3.0). These are major revisions to the templates meaning that after a transition period, the FDA expects all new submissions to be made using these versions of the templates.
