As of October 1, 2025 all De Novo submissions must be submitted as electronic submissions using eSTAR with any exemptions noted in “Waivers and Exemptions from Electronic Submission Requirements”. eSTAR is also available for voluntary use for Investigational Device Exemption (IDE) original and supplement submissions and PMA 30-day notice supplement submissions.
The FDA’s electronic Submission Template And Resource (eSTAR) continues to evolve as the agency refines its digital submission tools for medical device applicants. The latest release, version 5.5 (February 12, 2025), delivered incremental but meaningful improvements focused on usability, validation, and clarity, rather than sweeping regulatory changes.
While this version did not alter submission policy, it did enhance how sponsors interact with the template, validate attachments, and prepare content for submission through the CDRH Customer Collaboration Portal. Below, we summarize the key updates and highlight what changed from v5.4 to v5.5.
Summary of Changes in eSTAR v5.5
At its core, eSTAR provides a structured, interactive environment for preparing 510(k), De Novo, and Q-Submission files. Each new version aims to improve both user experience and data integrity.
The main highlights of eSTAR v5.5 include:
- Modernized Indications for Use Section: The traditional FDA Form 3881 layout has been replaced with an eSTAR-native format that supports multiple jurisdictions. This streamlines data entry and aligns the Indications for Use section with other eSTAR modules.
- File Type Validation: The new version introduces stricter attachment validation, preventing users from uploading unsupported file types, reducing the risk of submission errors and subsequent RTA (Refuse to Accept) feedback.
- Expanded Text Fields: Text boxes throughout the template have been resized to improve readability and ensure clean formatting when exported or printed as a flattened PDF.
- Updated Help Text and Guidance References: Several sections now include updated help text, incorporating references to the FDA’s Predetermined Change Control Plan (PCCP) guidance and contextual notes for cybersecurity and labeling topics.
- Consolidated EMC Labeling Questions: Previously, multiple electromagnetic compatibility (EMC) labeling questions appeared across different sections. These have been merged into a single, comprehensive question, improving clarity and reducing redundancy.
- Display Bug Fixes: Users who viewed submissions in non-Adobe PDF editors previously encountered rendering issues in clinical testing sections. These bugs have been corrected for consistent display across platforms.
- De Novo Submissions: Upcoming Mandate: The FDA has confirmed that De Novo submissions must use eSTAR starting October 1, 2025. While still optional for 510(k)s and Q-Subs, this mandate signals the agency’s intent to make eSTAR the standard format across all device types.
eSTAR v5.4 vs v5.5
| Feature / Section | Before (v5.4 / earlier) | After (v5.5) |
| Indications for Use | Based on FDA Form 3881 (single jurisdiction) | eSTAR model format supporting multiple jurisdictions |
| Attachment File Validation | Allowed unsupported file types in some cases | Validation prevents unaccepted formats |
| Text Box Sizes | Smaller fields; limited readability when flattened | Expanded fields; improved readability and printability |
| Help Text | Static and partially outdated | Updated references including PCCP guidance |
| EMC Labeling Questions | Multiple separate EMC questions | Consolidated into one comprehensive question |
| Clinical Testing Display | Rendering issues in non-Adobe editors | Bug fix ensures proper display |
| Versioning / Use Policy | v5.4 current; v5.x acceptable until v6.0 | v5.5 current; maintains compatibility with prior v5.x |
| Scope of Content | No major content changes | Minor enhancements (e.g., cybersecurity help text) |
| Policy Impact | No new policy implications | No regulatory change; usability updates only |
Implications and Next Steps
Although eSTAR v5.5 does not introduce new regulatory requirements, it does impact submission preparation workflows. The enhancements reduce the likelihood of validation errors and improve alignment between eSTAR fields and supporting documentation.
Key takeaways for regulatory teams:
- Mandatory De Novo Use: eSTAR is mandatory for all De Novo submissions as of October 1, 2025. Sponsors should begin familiarizing themselves with the template now.
- Efficiency and Compatibility: File validation and layout updates help reduce RTA risk and ensure smoother interactions with FDA reviewers.
- Recommended Actions:
- Update internal SOPs and templates to reference eSTAR v5.5
- Train submission teams on new validation rules and help text
- Conduct a test submission through the FDA CDRH Portal to confirm compatibility and resolve issues early
Looking ahead, version 6.0 is expected to include more substantial content updates and policy-related revisions. For now, v5.5 represents an incremental but worthwhile step toward more efficient and standardized digital submissions.
References
- FDA eSTAR Program Overview: https://www.fda.gov/medical-devices/how-study-and-market-your-device/estar-program
- Medical Device Academy: FDA eSTAR Updates and Submission Best Practices
- Emergo by UL: eSTAR Version 5.5 Released – What You Need to Know
Conclusion
While the shift from eSTAR v5.4 to v5.5 may appear minor, the update underscores the FDA’s ongoing commitment to improving submission usability and consistency. For regulatory professionals, adopting v5.5 now ensures smoother submissions, fewer validation errors, and readiness for the upcoming De Novo mandate.
As the eSTAR program continues to mature, one thing is clear: digital-first submissions are no longer the future, they’re the present.
