Key Principles (Findings)
This guidance establishes that the eSTAR platform will become the mandatory format for the electronic submission of medical device Pre-Submissions to the FDA. A key principle is that a properly completed eSTAR submission is considered a ‘complete’ submission, which allows it to bypass the traditional Refuse-to-Accept (RTA) process and instead undergo a more focused technical screening within 15 days. The structure of the eSTAR template is designed to align with the FDA’s internal review memo, creating a more efficient and consistent review process. The guidance also makes it clear that while eSTAR use is currently voluntary, it will become required for Pre-Subs at least one year after this guidance is finalized.

Recommendations for Industry
The primary recommendation for industry is to familiarize themselves with and begin voluntarily using the eSTAR platform for Pre-Submissions in advance of the mandatory deadline. The guidance recommends that submitters use the structured, dynamic PDF to ensure all necessary elements of a complete submission are included, thereby facilitating a smoother and more efficient review. For certain types of follow-up communications, such as submitting meeting minutes or presentation slides, the guidance recommends they continue to be submitted as an eCopy rather than through the eSTAR template.

Regulatory Considerations
This guidance is issued under the authority of the Federal Food, Drug, and Cosmetic (FD&C) Act, which mandates the transition to electronic-only submissions. Upon finalization, the requirement to use the eSTAR template for Pre-Subs will be a binding regulatory requirement. The guidance outlines a specific technical screening process for eSTAR submissions that will replace the RTA process. If a submission fails this screening, it will be placed on hold, and the review clock will restart upon receipt of the corrected information. The document also specifies certain types of submissions, such as appeals and withdrawal requests, that will be exempt from the mandatory eSTAR requirement.