eSTAR Deep Validation Tool

Catch submission issues before FDA review. Our comprehensive eSTAR validation tool automatically identifies RTA risks, missing sections, compliance gaps, and formatting errors that could delay or reject your 510(k) submission.

How It Works

The eSTAR Deep Validation tool performs a comprehensive analysis of your submission package by:

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RTA Risk Assessment: Scans all sections against FDA's Refuse to Accept (RTA) checklist, identifying missing required elements, incomplete forms, and non-compliant formatting that would trigger an automatic rejection.
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Section Completeness Check: Validates that all mandatory eSTAR sections are present and properly structured, including device description, substantial equivalence, labeling, and performance testing documentation.
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Cross-Reference Validation: Ensures consistency across sections—verifying that device classifications match, predicate devices are properly cited, and testing data aligns with claims made in the summary.
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Regulatory Compliance Scan: Checks against current FDA guidance documents, special controls, and consensus standards to identify gaps in required documentation or testing requirements.
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Format & Structure Verification: Validates file formats, naming conventions, PDF structure, and eSTAR template compliance to ensure technical acceptance.

What It Does

This tool provides a detailed validation report that includes:

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Critical Issues: Problems that will result in RTA or significant delays (missing forms, incomplete sections, non-compliance with special controls)
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Warning Items: Potential concerns that may trigger FDA questions or requests for additional information
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Recommendations: Best practice suggestions to strengthen your submission and reduce review time
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Compliance Score: Overall submission readiness percentage with actionable improvement areas
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Exportable Report: Professional PDF validation report with your branding that can be shared with clients or included in project documentation

⏱️ How It Saves Time

Saves 10-15 hours per submission by automating manual validation tasks:

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Instant RTA Check: What takes 2-3 hours of manual checklist review is completed in seconds, catching issues before submission
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Automated Cross-Reference: Eliminates 3-4 hours of manual section-by-section consistency checking across hundreds of pages
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Regulatory Gap Analysis: Saves 2-3 hours by automatically identifying missing special controls, standards, or guidance requirements
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Prevents Costly Rejections: Avoids weeks of delay and resubmission work by catching issues upfront—saving 20-40 hours of rework per rejection
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Client Confidence: Provides professional validation reports that demonstrate thoroughness, reducing back-and-forth questions and saving 2-3 hours of client communication

ROI: for FDA 510k Consultants charging $150-300/hour, this tool saves $1,500-$4,500 in billable time per submission while improving submission quality and client satisfaction.

Perfect For

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FDA 510k FDA 510k consultants reviewing client eSTAR submissions before FDA submission
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Regulatory teams performing final quality assurance checks
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Firms managing multiple submissions who need consistent validation standards
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FDA 510k FDA 510k consultants providing "redline review" services on AI-generated submissions

Get Free Access to eSTAR Deep Validation

This tool is completely free for verified FDA 510k consultants in the Cruxi network. Join thousands of regulatory professionals who use our tools to save 20+ hours per week.

Join 510k Consultant Network (Free)

✓ No subscription fees • ✓ All 15 tools included • ✓ Export with your branding