What Is FDA's eSTAR? Electronic Submission Template Guide 2025
- Beng Ee Lim
- Jul 3
- 7 min read
FDA's eSTAR (electronic Submission Template And Resource) is an interactive PDF form that guides medical device companies through preparing comprehensive electronic submissions. eSTAR is mandatory for 510(k) submissions since October 2023, becomes required for De Novo requests in October 2025, and will extend to Q-Submissions after a transition period.
Quick Answer: eSTAR standardizes FDA submissions through interactive templates with built-in databases, automated validation, and integrated forms. Properly completed eSTAR submissions bypass refuse-to-accept (RTA) reviews and align with FDA's internal review systems for faster processing.
This guide covers eSTAR compliance deadlines, technical requirements, and submission preparation procedures.
What Is FDA's eSTAR Program?
eSTAR (electronic Submission Template And Resource) is FDA's standardized electronic submission platform that replaces traditional paper and PDF-based submissions with interactive, guided templates.
Launched to improve submission quality and review efficiency, eSTAR provides structured templates with built-in databases, automated validation, and integrated forms that align directly with FDA's internal review systems.
Core eSTAR Features
Interactive Guidance: Dynamic PDF templates that show/hide sections based on device characteristics and responses to built-in questions.
Automated Validation: Real-time verification that identifies missing information and highlights incomplete sections before submission.
Integrated Databases: Built-in access to FDA product codes, consensus standards, and device-specific guidance documents.
Standardized Format: Consistent submission structure that aligns with FDA's internal Submission Memo And Review Template (SMART).
No RTA Review: Properly completed eSTAR submissions bypass refuse-to-accept reviews, accelerating the review start timeline.
Why FDA Implemented eSTAR
Submission Quality Issues: Traditional submissions varied widely in format and completeness, requiring extensive FDA review time for basic administrative processing.
Review Efficiency: Standardized format allows FDA reviewers to locate information quickly and focus on scientific review rather than document organization.
Industry Feedback: Medical device companies requested clearer guidance on submission requirements and expected content organization.
Regulatory Modernization: Part of FDA's broader digital transformation initiative to streamline regulatory processes.
eSTAR Compliance Timeline: What's Required When
Currently Mandatory
510(k) Submissions (Since October 1, 2023) All 510(k) submissions—Traditional, Special, Abbreviated, and supplements—must use eSTAR format unless specifically exempted.
Exemptions include:
Submissions with software requiring specialized formatting
Certain combination product submissions
Emergency use situations with FDA approval
Coming October 1, 2025
De Novo Requests (Mandatory) All De Novo classification requests must use eSTAR format after October 1, 2025, following finalization of the De Novo eSTAR guidance.
Current Status: Voluntary use available; final guidance expected by September 30, 2025.
Future Implementation
Q-Submissions (Timeline TBD) FDA issued draft guidance May 28, 2025, proposing mandatory eSTAR for Pre-Submissions after one-year transition period following final guidance.
PMA Applications: No timeline announced, but pilot eSTAR templates available for voluntary use.
Small Business Determination Requests
Electronic Submission Mandatory (Since November 1, 2024) All Small Business Determination requests must be submitted electronically through the CDRH Portal.
How eSTAR Works: Interactive Submission Process
Template Structure and Navigation
Guided Workflow: eSTAR templates guide users through submission preparation with dynamic sections appearing based on device characteristics.
Color-Coded Status: Red highlighting for missing information, green for completed sections, providing real-time completion status.
Progress Tracking: Built-in verification system showing completion percentage and remaining requirements.
Section Dependencies: Responses to key questions determine which subsequent sections appear, customizing templates to specific device types.
Built-In Databases and Auto-Population
FDA Product Codes: Automatic population of classification information and applicable regulations based on product code selection.
Consensus Standards: Integration with FDA-recognized standards database for automatic identification of applicable requirements.
Device-Specific Guidance: Direct links to relevant FDA guidance documents based on device type and intended use.
Form Integration: Built-in FDA forms including Form 3514, 510(k) Summary, Declaration of Conformity, and Indications for Use.
Automated Validation and Error Checking
Real-Time Validation: Immediate feedback on missing required information, incorrect formatting, or incomplete sections.
Pre-Submission Verification: Comprehensive validation check before submission ensuring all required elements are present.
Technical Screening: FDA conducts automated technical screening to verify submission completeness and attachment relevance.
Error Prevention: Template logic prevents common submission errors through guided data entry and validation rules.
Preparing Your First eSTAR Submission
Pre-Submission Planning
Device Characterization: Clearly define device type, intended use, technological characteristics, and classification before starting eSTAR.
Gather Required Information: Compile all necessary technical documentation, test reports, labeling, and regulatory history.
Team Coordination: Ensure all team members understand eSTAR requirements and have access to Adobe Acrobat Pro.
Template Selection: Download appropriate eSTAR template (510(k), De Novo, PMA) from FDA website and save locally.
Step-by-Step Completion Process
1. Initial Setup
Open saved eSTAR template in Adobe Acrobat Pro (not web browser)
Complete administrative sections including contact information and device identification
Select appropriate product code to activate relevant template sections
2. Device Description
Provide comprehensive device description using guided prompts
Complete technological characteristics section with detailed specifications
Address software components if applicable using dynamic software sections
3. Regulatory Information
Document regulatory history and previous FDA interactions
Complete predicate device analysis for 510(k) submissions
Identify applicable consensus standards using built-in database
4. Testing and Evidence
Upload test reports and supporting documentation as attachments
Complete risk analysis sections using template guidance
Address labeling requirements including UDI and cybersecurity information
5. Validation and Review
Use built-in validation tools to verify submission completeness
Review color-coded status indicators for missing information
Conduct final verification before submission
Common Preparation Challenges
Software Compatibility Issues: Ensure Adobe Acrobat Pro is current version and properly configured for eSTAR template functionality.
File Size Management: Compress large attachments and videos to meet size limitations while maintaining readability and quality.
Template Navigation: Allow adequate time to learn template structure and dynamic section behavior before deadline pressure.
Team Coordination: Establish clear workflows for multi-person submissions including document sharing and version control procedures.
eSTAR Compliance Strategies
Implementation Planning
Training Investment: Budget 8-16 hours for team training on eSTAR requirements and template navigation for first submission.
Software Setup: Ensure all team members have Adobe Acrobat Pro access and proper computer specifications for template functionality.
Process Documentation: Develop internal procedures for eSTAR submission preparation including quality control checkpoints.
Template Familiarization: Practice with eSTAR templates before submission deadlines to understand dynamic sections and validation requirements.
Quality Control Procedures
Multi-Person Review: Implement review procedures ensuring technical experts verify their sections and regulatory professionals confirm overall completeness.
Validation Checklist: Use eSTAR's built-in validation plus internal quality control procedures to verify submission completeness.
File Management: Establish procedures for managing large files, attachment organization, and version control throughout preparation process.
Backup Planning: Maintain backup procedures for submission files and alternative submission methods if technical issues arise.
Deadline Management
Preparation Timeline: Allow 2-4 weeks additional time for first eSTAR submission compared to traditional format submissions.
Technical Support: Identify FDA technical support resources and internal IT support for troubleshooting submission issues.
Contingency Planning: Develop procedures for requesting waivers or handling technical submission problems near deadline dates.
Version Updates: Monitor FDA communications for eSTAR version updates and plan upgrade procedures accordingly.
Troubleshooting Common eSTAR Issues
Technical Problems and Solutions
Template Won't Open Properly
Ensure Adobe Acrobat Pro (not Reader) is installed and current
Download template directly to computer rather than opening in web browser
Clear browser cache and download fresh template copy
Attachment Upload Failures
Verify attachment size is under 1GB limit
Compress large files using recommended formats
Check total submission size remains under 4GB limit
Validation Errors
Review red-highlighted sections for missing required information
Verify product code selection matches device characteristics
Ensure all mandatory fields are completed before final validation
Submission Portal Issues
Verify CDRH Portal account credentials and permissions
Check internet connection stability for large file uploads
Contact FDA technical support for persistent portal problems
Content and Compliance Issues
Dynamic Sections Not Appearing
Verify accurate responses to key device characterization questions
Check product code selection triggers appropriate template sections
Review device description completeness to activate relevant requirements
Consensus Standards Not Populating
Ensure product code selection is accurate and complete
Verify device characteristics match standards database criteria
Manually identify applicable standards if automatic population fails
Form Integration Problems
Complete all required information before attempting form generation
Verify data consistency between eSTAR sections and integrated forms
Use manual form completion if automatic generation encounters errors
FDA Communication and Support
Technical Support Resources: FDA provides technical support for eSTAR template functionality and submission portal issues.
Guidance Document Updates: Monitor FDA guidance documents for clarifications and updates to eSTAR requirements.
Industry Feedback Channels: FDA accepts feedback on eSTAR functionality through formal comment periods and industry meetings.
eSTAR: The New Reality of FDA Submissions
eSTAR represents FDA's commitment to regulatory modernization and improved review efficiency. While the transition requires initial investment in training and process development, the standardized format ultimately benefits both industry and FDA through improved submission quality and streamlined reviews.
Your regulatory success depends on adapting to FDA's digital transformation. Master eSTAR now, and your submissions will be ready for the future of regulatory review.
Ready to streamline your FDA submissions?
Complizen's AI-powered regulatory platform helps medical device companies navigate eSTAR requirements and optimize submission preparation for faster regulatory success.
Frequently Asked Questions
Do I need eSTAR for all FDA submissions?
Currently, eSTAR is mandatory only for 510(k) submissions and will become required for De Novo requests in October 2025. Q-Submissions will require eSTAR after the final guidance is published and transition period expires. PMA submissions can use eSTAR voluntarily.
Can I request a waiver from eSTAR requirements?
Yes, but waivers are granted only in limited circumstances such as technical impossibility, emergency situations, or specific FDA determination that eSTAR is inappropriate for the submission. Waiver requests must be submitted with detailed justification.
What happens if my eSTAR submission has technical problems?
FDA conducts technical screening for eSTAR submissions. If technical issues are identified, your submission may be placed on technical screening hold for up to 180 days until a complete replacement is submitted.
How do eSTAR submissions affect review timelines?
eSTAR submissions that pass technical screening bypass refuse-to-accept review, potentially accelerating review initiation. However, overall review timelines depend on scientific content quality and complexity rather than submission format.
Can I get help preparing my first eSTAR submission?
Yes, many regulatory consulting firms offer eSTAR preparation services. Additionally, FDA provides technical support for template functionality and submission portal issues through their help desk.
