Free FDA 510(k)
Checklist Generator
Get a personalized, RTA-compliant checklist for your medical device in under 60 seconds. Based on your device profile, our AI generates a comprehensive submission checklist with conditional modules, evidence requirements, and eSTAR alignment.
clinical_notes Device Profile
Your Personalized Checklist
Complete the form on the left to generate your custom FDA 510(k) submission checklist with conditional modules and evidence requirements.
Why Use Our Checklist Generator?
Built by regulatory experts who understand the nuances of FDA 510(k) submissions.
RTA-Compliant
Based on current FDA RTA checklists and eSTAR requirements. Reduces the risk of Refuse to Accept letters.
Conditional Logic
Smart checklist adapts based on your device profile. Only shows relevant requirements for software, sterile, electrical devices, etc.
Evidence Buckets
Organizes requirements into 9 evidence categories: FDA Guidance, Test Reports, Software Docs, Risk Management, and more.
Export Options
Download as PDF for printing or CSV for project management. Share with your team or regulatory consultants.
Instant Results
Generate comprehensive checklists in seconds. No signup required for basic functionality.
AI-Powered Generation
Advanced AI analyzes your device profile to generate personalized, RTA-compliant checklists in seconds.
Generate Your Complete FDA 510(k) Submission
Use our AI-powered checklist generator to create a personalized, RTA-compliant submission checklist. Get instant results with conditional modules based on your device profile.
Beta version access restricted. Request access to our full AI-powered 510(k) submission platform.