FDA Publishes Draft Guidance for Electronic Q-Submissions with New eSTAR Template
On May 29, 2025, the US Food and Drug Administration (FDA) published a draft guidance proposing the mandatory adoption of a structured electronic template for Q-Submissions - with an emphasis on Pre-Submissions in the context of medical devices.
This document is in compliance with article 745A(b) of the Federal Food, Drug, and Cosmetic Actwhich makes electronic submissions mandatory in certain types of regulatory proceedings. The new model - eSTAR (electronic Submission Template And Resource) - was already being used on a voluntary basis, but will now be formally required after a transition period of at least 12 months from the publication of the final version of the guidance.
What changes for manufacturers?
The guide proposes that all Pre-Submissions - including originals, supplements and amendments - be submitted exclusively via the structured electronic platform eSTAR. This model includes standardized fields, drop-down menus, checkboxes and guided prompts, ensuring greater consistency, quality and efficiency in the preparation and review of dossiers.
Other highlights:
There will be no need to go through the traditional"Refuse to Accept" (RTA) process, as the targeted structure ensures that the essential content is included.
In the event of missing information, a technical screening process will be applied with the possibility of corrections within 180 days.
Submissions that do not use eSTAR, where required, will not be accepted from the date of final implementation, with specific exceptions such as interactive responses, meeting minutes, or withdrawal requests.
Exemption and support during the transition
During the transition period, the use of eSTAR remains voluntary and is strongly encouraged in order to familiarize users with the tool. The FDA also provides technical assistance and detailed documentation to support users in this transition.
Smart MDR follow-up
Smart MDR closely follows the evolution of the FDA guidelines and supports its clients in preparing and adapting their submission processes to the new eSTAR model.
Whether Pre-Submissions or 510(k), compliance with formal electronic submission requirements is essential to avoid delays, increase the predictability of the review and reduce regulatory risk.
Talk to us to make sure your submissions are ready for the new FDA standards.
Be Smart. Be Compliant.
