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The FDA has set a firm deadline: beginning October 1, 2025, all De Novo medical device submissions must be made using the electronic Submission Template And Resource (eSTAR) platform. This mandate reflects the FDA’s continued push for a standardized, digital-first approach to streamline reviews, improve completeness, and enhance communication between sponsors and the agency.
At RQMIS, we’ve not only embraced this transformation—we’ve helped pioneer it.
What Is eSTAR and Why It Matters
eSTAR is an interactive PDF form that guides applicants through the process of preparing comprehensive 510(k) and De Novo submissions. It ensures key sections are completed, reduces the likelihood of receiving a Refuse to Accept (RTA) letter, and improves the efficiency of FDA reviews.
By October 2025, the use of eSTAR will no longer be optional for De Novo submissions. This makes early familiarity and strategic use of the format essential for medical device manufacturers planning ahead.
Our Track Record: De Novo eSTAR Success for the U.S. Army
RQMIS has already leveraged eSTAR in De Novo pathways—most notably during our collaboration with the U.S. Army Medical Materiel Development Activity (USAMMDA). In this high-impact engagement, we:
- Led the regulatory strategy and authored the complete De Novo submission for a software as a medical device (SaMD) machine learning (ML) algorithm, APPRAISE-HRI.
- Utilized eSTAR for the entire De Novo submission process, ensuring structured, complete documentation from the outset.
- Received FDA clearance for the device—demonstrating that our eSTAR-based approach not only met regulatory standards but accelerated the process.
This success story, which you can read about in detail on our Army Project Success page, shows our ability to navigate high-stakes, technically complex submissions using modern FDA frameworks.
Why Choose RQMIS for Your De Novo eSTAR Submissions
With the compliance clock ticking, RQMIS stands as a proven partner to help you transition smoothly to eSTAR. Our clients benefit from:
- Firsthand experience with eSTAR for De Novo submissions—successfully executed before the mandatory deadline.
- Expert regulatory authors and strategists who know how to align product design with FDA expectations.
- End-to-end support, from pre-submission planning and eSTAR formatting to final FDA approval.
The Clock Is Ticking—Act Now
October 2025 may seem distant, but preparing a De Novo submission takes time. Waiting until the deadline approaches means unnecessary risk. By partnering with RQMIS now, you’ll gain the strategic advantage of early adoption—and a team that has already been there.
Let’s start the conversation today about your product’s De Novo pathway and how we can bring our eSTAR expertise to your team.