Device Description Generator

Automatically draft device description sections for 510(k) submissions with figure checklists and comparison tables. This free tool saves consultants 2-3 hours per submission by generating properly structured device description content with FDA-compliant formatting.

How It Works

The Device Description Generator creates comprehensive device description content:

check_circle
Structured Content Generation: Generates device description sections with proper structure including device name, intended use, indications for use, device classification, and technological characteristics.
check_circle
Figure Checklist Creation: Automatically creates checklists for required figures and diagrams including device photos, schematics, labeling, and use environment illustrations.
check_circle
Comparison Table Framework: Generates comparison table structures for comparing your device to predicate devices, including columns for intended use, technological characteristics, materials, and performance specifications.
check_circle
FDA-Compliant Formatting: Ensures content follows FDA eSTAR formatting requirements and submission guidelines for device description sections.
check_circle
Content Templates: Provides device-type-specific templates and content frameworks that can be customized for specific devices.

What It Does

This tool generates comprehensive device description documentation:

fact_check
Device Description Draft: Complete device description section draft with all required subsections and content structure
fact_check
Figure Checklist: Comprehensive checklist of required figures, diagrams, and illustrations with descriptions
fact_check
Comparison Table Template: Structured comparison table framework for predicate device comparisons
fact_check
Content Guidance: Guidance on what information to include in each section and how to format content
fact_check
Exportable Draft: Professional PDF device description draft with your branding that can be customized and finalized

⏱️ How It Saves Time

Saves 2-3 hours per submission by automating device description creation:

schedule
Content Structure Generation: Eliminates 1-2 hours of manually creating device description section structure and organizing content
schedule
Figure Checklist Creation: Saves 30-60 minutes of identifying required figures and creating figure checklists
schedule
Comparison Table Setup: Automates 30-60 minutes of creating comparison table structures and formatting
schedule
Formatting Compliance: Ensures FDA-compliant formatting, saving 15-30 minutes of formatting review and adjustments

ROI: for FDA 510k Consultants preparing 10+ submissions per month, this tool saves 20-30 hours monthly while ensuring consistent, compliant device descriptions.

Perfect For

check_circle
FDA 510k consultants drafting device description sections for 510(k) submissions
check_circle
Regulatory teams preparing eSTAR submissions with device description content
check_circle
Firms providing regulatory writing services for medical device companies
check_circle
FDA 510k consultants reviewing and improving client-provided device descriptions

Need a specialist for your submission?

If you want expert help with 510(k) strategy, testing, or compliance, compare vetted providers in the Cruxi directories hub.

Get Free Access to Device Description Generator

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