eSTAR for SaMD: What Changes After Oct 1 2025?

Beng Ee Lim
May 20
2 min read

TL;DR:

Starting October 1, 2025, all De Novo requests for SaMD must be submitted using the FDA’s eSTAR template. This shift brings new module requirements tailored to software, including design documentation, cybersecurity, verification/validation, and AI lifecycle controls. If you're preparing a SaMD De Novo, this format isn’t optional—it’s the new standard.

What Is eSTAR?

eSTAR stands for Electronic Submission Template and Resource. It’s a structured, interactive PDF the FDA developed to standardize device submissions.

510(k) eSTAR became mandatory in October 2023.
Now, De Novo requests must also use eSTAR starting October 1, 2025.

Benefits:

Built-in validation checks
Auto-populated fields for consistency
Reduced review times due to uniform formatting

The FDA says the eSTAR reduces refuse-to-accept (RTA) rates by flagging errors before submission. But for SaMD companies, it also introduces new content expectations—especially around software-specific documentation.

Key Changes for De Novo SaMD

As of October 2025, you must use the “Electronic Submission Template for Medical Device De Novo Requests”.

Here’s what matters for SaMD teams:

🔹 Software Description & Design Controls

Describe the intended use, architecture, and software functions
Map to design inputs/outputs and risk controls

🔹 SBOM & Cybersecurity

Submit a full Software Bill of Materials (SBOM)
Include cyber risk management and threat mitigation strategies

🔹 Software Verification & Validation

Show traceability matrix
Include test protocols, error handling, edge-case testing

🔹 Device Software Function & AI/ML Lifecycle

Describe Device Software Functions (DSFs)
If AI-enabled, include model training, performance bounds, and update plans

Note: This is where the FDA expects transparency about algorithm retraining and human-in-the-loop safeguards.

How These Changes Impact Your SaMD Filing

This isn’t just a new form—it’s a new submission philosophy.

You’ll need to:

Reorganize your documentation into eSTAR-defined modules
Use only the latest eSTAR version (download from FDA’s CDRH site)
Ensure internal teams and vendors (e.g., software test labs) deliver in compatible formats

Timeline shifts:

Allow 1–2 extra weeks for eSTAR PDF formatting and validation
Portal upload requires strict file-size limits (<150 MB PDF)
Plan a pre-submission Q-Sub for complex DSF or AI features

Common eSTAR pitfalls:

❌ Missing required XML tags
❌ Table of contents doesn’t match module order
❌ Using outdated template version (always check for updates)

Step-by-Step eSTAR Prep Checklist

Module	Docs Needed	Owner	Status
Software Description	Architecture diagrams, user-needs traceability	…	[ ]
Design Controls	Risk assessment (ISO 14971), requirement specs	…	[ ]
SBOM & Cybersecurity	Software BOM, patch-management plan	…	[ ]
Verification & Validation	Test protocols, reports, validation summary	…	[ ]
DSF & AI/ML Lifecycle	Model description, performance metrics, PCCP	…	[ ]

Best Practices & Pro Tips

✅ Always use the latest template (verify on FDA’s eSTAR page)
✅ Validate early: run your draft through the eSTAR Validator before final upload
✅ Leverage auto-populated sections for device identifiers, product codes, and predicate references
✅ Keep version control: name your files eSTAR_DeNovo_v5.2_YourDeviceName.pdf

FAQs

Q: Is eSTAR mandatory for my 510(k) and De Novo?

Yes—510(k) since 2023, and De Novo starting October 1, 2025.

Q: What if I miss the Oct 1, 2025 deadline?

Your submission will be rejected—FDA won’t accept De Novos outside the eSTAR format after that date.

Q: Where do I get the latest eSTAR template?

From the FDA’s CDRH website under the eSTAR program section.