The FDA has published a draft guidance establishing the mandatory use of the eSTAR electronic template for all Q-Submissions, including Pre-Submissions, within the scope of medical device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.

The FDA 's new guidance on the Q-Submission Program offers practical guidelines for manufacturers who intend to request formal feedback or technical meetings during the planning or review of regulatory submissions for medical devices and IVDs.