The FDA has released eSTAR Version 7.0, integrating new Human Factors content and expanding PreSTAR capabilities. Learn how these changes may affect medical device manufacturers preparing FDA submissions.

The FDA has published a draft guidance establishing the mandatory use of the eSTAR electronic template for all Q-Submissions, including Pre-Submissions, within the scope of medical device regulation. This proposal aims to improve the quality, consistency and traceability of submissions made to the FDA, progressively replacing free formats with a structured, digital template.