The FDA eSTAR Program: Navigating Mandatory Submissions and Mastering Version Control

Executive Summary 

The United States Food and Drug Administration (FDA) has fundamentally transformed the medical device regulatory landscape by transitioning from traditional paper and eCopy submissions to the electronic Submission Template And Resource (eSTAR) program.

As of recent updates, including the major release on June 1, 2026, understanding the intricacies of the eSTAR system is no longer optional - it is a critical competency for MedTech regulatory affairs teams. This white paper expands upon the recent eSTAR updates, explores the mandatory implementation timelines across different submission types, details the FDA’s versioning methodology, and provides actionable strategies to avoid the administrative pitfalls of the eSTAR "Version Trap."

1. Background: What is the eSTAR Program? 

The eSTAR program was established by the FDA to implement Section 745A(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which mandates electronic submissions for certain medical device applications.

Unlike previous submission methods (such as the eCopy program, which simply required an unstructured PDF on a physical drive), the eSTAR is an interactive, highly structured PDF template with built-in logic, automated completeness verification, and embedded guidance. The template is specifically designed to guide applicants through the preparation of a comprehensive premarket submission, standardizing the format so that FDA reviewers can navigate the data more efficiently.

One of the most notable features of the eSTAR is its automated completeness check, visually represented by a banner at the top of the document. If required fields are missing, the banner remains red; once all mandatory information is complete, it turns green, indicating the file is ready for submission. This automated verification eliminates the traditional "Refuse to Accept" (RTA) checklist review for administrative completeness, reducing the chance of an immediate rejection for missing sections.

2. Mandatory vs. Voluntary Submission Types

The transition to eSTAR has been rolled out in phases, moving from a voluntary pilot program to strict mandatory requirements for the most common premarket pathways.

Mandatory Submissions:

·       510(k) Premarket Notifications: Since October 1, 2023, all 510(k) submissions - including Traditional, Special, and Abbreviated 510(k)s—must be submitted using the eSTAR template. Submissions that fail to use this format are not accepted for review.

·       De Novo Classification Requests: The FDA expanded the mandatory requirement to include all De Novo classification requests starting October 1, 2025.

Voluntary Submissions: The FDA continues to expand the eSTAR program's capabilities, allowing manufacturers to voluntarily use the platform for several other regulatory pathways:

·       Premarket Approval (PMA): Original PMAs, PMA Panel Track Supplements, Real-Time Supplements, 180 Day Supplements, and 30-Day Notices can be submitted voluntarily.

·       Investigational Device Exemptions (IDE) & 513(g) Requests: Available for voluntary submission to both CDRH and CBER.

·       Q-Submissions (via PreSTAR): The FDA provides a dedicated template known as the Early Submission Requests eSTAR (PreSTAR). As of the recent Version 3.0 update, it is available for voluntary use with Pre-Submissions, Submission Issue Requests, Informational Meetings, Study Risk Determinations, PMA Day 100 Meetings, and Accessory Classification Requests.

3. Understanding eSTAR Version Updates: Why and How the FDA Changes the Template

Because the eSTAR is a dynamic document reflecting current regulatory expectations, the FDA continuously updates the templates to align with new final rules, policies, and guidance documents.

Major vs. Minor Version Updates:

·       Major Version Updates: These reflect significant revisions to the template driven by new regulatory policies or final guidances. They are denoted by a whole number increment (e.g., Version 6.0 to 7.0). If a manufacturer submits a device using an outdated major version, they run a high risk of receiving Additional Information (AI) requests because the older template lacks the newly required data fields for compliance.

·       Minor Version Updates: These involve smaller corrections or bug fixes, denoted by a decimal increment (e.g., Version 6.1 to 6.2). Using a previous minor version typically does not increase the risk of AI requests.

Recent Drivers for Version Updates: The FDA's templates have evolved rapidly in 2026. For example, Version 6.1 was released in February 2026 to align with the new Quality Management System Regulation (QMSR), which incorporated ISO 13485:2016 by reference. Shortly after, updates were made to accommodate the FDA's new Real-World Evidence (RWE) guidance.

The June 2026 Version 7.0 Update: On June 1, 2026, the FDA released a major update to both the In Vitro Diagnostic (IVD) and non-IVD eSTAR templates (Version 7.0). This update was specifically deployed to fully integrate the FDA's new Content of Human Factors Information in Medical Device Marketing Submissions guidance, which was finalized on May 29, 2026, and becomes strictly effective for submissions on or after August 1, 2026.

 4. Navigating the eSTAR "Version Trap" One of the most frequent administrative headaches MedTech regulatory teams face is the timeline gap between starting an eSTAR draft and finally submitting it.

A regulatory team may download an eSTAR template and begin populating the device description and intended use months before all Verification and Validation (V&V) testing is complete. Because rigorous bench, animal, or clinical testing can take several months, the FDA may release a new major version of the eSTAR template by the time the final V&V reports arrive.

The consequence is the "Version Trap": 

The team finds themselves stuck with an outdated template and must transfer all previously entered information into the newer version to avoid FDA pushback.

The XML Export/Import Solution (and Its Limitations): 

The FDA provides a technical workaround using Adobe Acrobat Pro. Users can click the "Export Data" button at the end of their older eSTAR file to generate an XML file containing their text responses. They can then open the new eSTAR version, click "Import Data," and load the XML file to instantly transfer their written content.

However, there is a critical limitation to this feature:

The XML data transfer does not carry over attachments. Because an eSTAR submission requires embedding all supporting evidence directly into the PDF—often dozens of individual test reports, labeling files, and cybersecurity documents—regulatory teams must manually re-upload every single attachment into the new version.

5. Strategic Version Management: Utilizing the FDA's Upgraded Website

To help manufacturers anticipate and manage these template transitions, the FDA has significantly improved the official eSTAR Program web page.

Before beginning a submission—and critically, right before finalizing it -regulatory teams should consult the FDA's eSTAR download table. The FDA now explicitly lists the retirement dates for older versions. For example, the FDA portal clearly indicates that the retiring Non-IVD and IVD eSTAR Version 6.2 will only remain valid until August 3, 2026.

Furthermore, the FDA website provides the option to download both the retiring version and the new updated version side-by-side.

Pro-Tip for Regulatory Teams: By utilizing this visibility, manufacturers can strategically choose which template to use based on their projected submission date. If a team is confident their V&V testing will conclude and the submission will be filed before the stated retirement date (e.g., before August 3, 2026), they can safely proceed with the older template without fear of technical rejection. If the timeline is expected to push past the retirement date, the team should proactively start their draft in the newest version (e.g., Version 7.0) to prevent the burden of manual attachment re-uploads down the line.

Conclusion

The FDA's eSTAR program has successfully standardized the 510(k) and De Novo review process, ensuring high-quality, comprehensive data collection while eliminating traditional Refuse to Accept (RTA) administrative holds. However, the dynamic nature of the template requires manufacturers to remain highly vigilant regarding version control, final guidance integrations (such as the recent Human Factors update), and strict attachment management. By actively monitoring the FDA's published retirement dates and strategically timing template selection, regulatory teams can avoid the eSTAR version trap and ensure their path to market clearance remains predictable and efficient.

At BioVision Ltd., our regulatory experts seamlessly support MedTech innovators through the entire eSTAR preparation, compilation, and submission process to ensure your clearances remain on track. Let's connect to see how we can support you.