Mastering the FDA eSTAR: A Guide for 2025

The eSTAR Revolution

The FDA's eSTAR (electronic Submission Template And Resource) is no longer optional. As of October 1, 2023, all 510(k) submissions must be submitted as eSTARs. For MedTech companies in 2025, mastering this dynamic PDF template is critical for avoiding "Refuse to Accept" (RTA) decisions.

FDA Building

What Changed in 2025?

While the fundamental structure remains the same, the FDA has tightened validations on:

Cybersecurity: New section requirements align with the latest guidance.
Biocompatibility: Automated logic now requires specific test reports based on device categorization.
Software Documentation: Enhanced granularity for software architecture.

3 Tips for a Smooth Submission

1. Don't Fight the Logic

The eSTAR PDF uses logic to hide/show sections. Do not try to attach files to sections that are grayed out. If a section is hidden, the FDA likely deems it irrelevant for your device type.

2. File Naming Matters

Attachments should follow a clear naming convention (e.g., 001_Device_Description.pdf). Avoid special characters that can break the XML generation.

Pro Tip: Keep individual attachment sizes under 100MB to ensure smooth upload to the CDRH Portal.

3. Use the Verification Feature

The eSTAR template has a built-in verification tool. Do not submit until you see the green "Complete" status at the top of the PDF.

Conclusion

Embracing eSTAR reduces the review timeline by eliminating the RTA phase. Treat the template not just as a form, but as a pre-submission checklist.