eSTAR Template
electronic Submission Template And Resource
Legal Requirement: This regulation is legally binding and must be complied with for US market access. Non-compliance can result in regulatory action, including warning letters, import detentions, and product recalls.
Overview
Scope
eSTAR (electronic Submission Template And Resource) is FDA's structured electronic submission template for 510(k) premarket notifications. eSTAR provides a guided, interactive format for preparing 510(k) submissions with built-in validation checks and automatic organization. FDA strongly recommends eSTAR for all 510(k) submissions, and it may become mandatory for certain device types.
Applicability
eSTAR is available for all 510(k) submissions. FDA strongly recommends using eSTAR for all new 510(k) submissions. Some device types may be required to use eSTAR. Traditional PDF submissions are still accepted but may take longer to review. eSTAR can be used for original 510(k)s, special 510(k)s, and abbreviated 510(k)s.
Why It Matters
eSTAR submissions are processed faster by FDA due to structured format and automatic validation. The template guides users through all required sections, reducing errors and omissions. eSTAR ensures consistent submission format, making review more efficient. Using eSTAR can reduce review time and improve likelihood of first-cycle approval. FDA is moving toward making eSTAR mandatory for all 510(k) submissions.
Key Concepts
- Structured electronic submission format
- Guided workflow through submission sections
- Automatic validation checks
- Faster FDA review processing
- Built-in help and guidance
- Attachment management
- PDF generation for submission
- Compatibility with FDA systems
eSTAR standardizes 510(k) format and accelerates FDA review. There's no reason not to use it.
eSTAR is FDA's structured submission template for 510(k)s—and it's now essentially mandatory. Use it. The guided format with validation checks actually makes preparation easier and reduces FDA review time. It's a win-win.
🔑 Key Takeaways
- →Always download the latest eSTAR version from FDA before starting.
- →Built-in validation catches common errors before submission.
- →Organize your attachments clearly—reviewers appreciate logical structure.
- →PDF generation from eSTAR is what you actually submit through ESG.
— ER | medev.ai
Building better devices, together.
eSTAR Template Features
Structured Sections
eSTAR organizes submission into structured sections: Administrative Information, Device Information, Predicate Device Information, Indications for Use, Device Description, Substantial Equivalence, Performance Data, Software Documentation, Biocompatibility, Sterilization, Labeling, and Truthful and Accurate Statement. Each section has specific fields and requirements.
Guided Workflow
eSTAR provides step-by-step guidance through each section with instructions, examples, and help text. The template indicates required vs. optional fields and provides context-specific guidance. Users can navigate between sections and save progress.
Validation Checks
eSTAR includes automatic validation checks to ensure completeness and consistency. The template checks for required fields, file attachments, and data consistency. Validation errors are flagged before submission, reducing FDA review delays.
Attachment Management
eSTAR allows attachment of supporting documents (test reports, drawings, labeling, etc.) in appropriate sections. Files can be uploaded in various formats (PDF, Word, Excel, images). The template organizes attachments by section.
Help and Resources
eSTAR includes built-in help text, links to FDA guidance documents, and examples. Users can access relevant FDA guidance directly from the template. Help text explains requirements and provides examples of acceptable responses.
PDF Generation
eSTAR generates a structured PDF submission package that can be submitted through FDA's Electronic Submission Gateway (ESG). The PDF includes all entered information and attachments in organized format suitable for FDA review.
Version Control
eSTAR templates are updated periodically. Users should download the latest version from FDA website. Older versions may not be accepted. Check FDA website for current eSTAR version requirements.
Compatibility
eSTAR is compatible with FDA's Electronic Submission Gateway (ESG) and review systems. Submissions prepared in eSTAR can be directly uploaded to ESG. The structured format facilitates FDA's automated processing and review.
Using eSTAR Template
Download Latest eSTAR Version
Download the latest eSTAR template from FDA website before starting. Check FDA website for current version requirements. Older versions may not be accepted. FDA periodically updates eSTAR.
Complete Administrative Information
Enter all administrative information including submitter information, device information, and contact details. Ensure all required fields are completed. eSTAR validation will flag missing required fields.
Enter Device and Predicate Information
Complete device description, indications for use, and predicate device comparison sections. Provide detailed information per eSTAR guidance. Use help text and examples provided in template.
Attach Supporting Documents
Attach all required supporting documents in appropriate sections: test reports (electrical safety, EMC, laser safety), drawings, labeling, software documentation, biocompatibility data. Ensure files are readable and properly formatted.
Complete Performance Data Sections
Enter performance data including test results, test methods, and conclusions. Reference attached test reports. Ensure all required testing is documented. Include NRTL certificates where applicable.
Review and Validate
Review entire eSTAR submission for completeness and accuracy. Use eSTAR validation checks to identify any issues. Review attached documents to ensure they support the submission. Have regulatory affairs review.
Generate PDF and Submit
Generate structured PDF submission package from eSTAR. Review PDF for completeness. Submit PDF through FDA Electronic Submission Gateway (ESG). Ensure ESG account and credentials. Keep confirmation and tracking number.
Respond to Validation Errors
If FDA identifies validation issues, respond promptly. Address errors and resubmit. Delayed responses extend review timeline. Consider teleconference to clarify issues with FDA.
Common Challenges & Solutions
Understanding eSTAR structure and requirements
Attend FDA eSTAR training sessions or webinars. Review FDA user guides and FAQs. Use help text and examples in template. Contact FDA with questions.
Attaching large files or multiple documents
Compress large files if needed. Organize documents logically. Ensure files are readable and properly formatted. Split very large files if necessary.
Validation errors and missing information
Complete all required fields. Review validation errors carefully. Ensure attached documents support entered information. Have regulatory affairs review before submission.
Related Regulations
Related Standards
Resources
Implementation Tools
Legal Notice: This page provides implementation guidance and educational content only. The actual regulation text is the legally binding document. Always refer to the official regulation published in the Code of Federal Regulations (CFR) and FDA guidance documents for compliance purposes.