FDA Filing Analysis
Submit and analyze FDA regulatory documents with AI-powered evaluation
Overview
The FDA Filing Analysis module uses three specialized AI agents to evaluate 510(k), PMA, and De Novo submissions. Each agent focuses on a specific aspect: clinical safety, operational efficiency, and regulatory compliance. The consensus algorithm combines their insights to provide a balanced assessment and approval likelihood score.
Supported Documents: 510(k) Premarket Notifications, PMA Applications, De Novo Requests, and related FDA submission documents in PDF or Word format.
How It Works
Upload Your Document
Select your FDA submission document or choose from our demo files to see the system in action.
Accepted formats: .pdf, .doc, .docx
Maximum file size: 50MBPreview Document
Use the preview feature to verify you're submitting the correct document. For demo documents, you can see the full content including clinical data and regulatory sections.
AI Analysis
Three AI agents analyze your document simultaneously:
Review Results
Receive a comprehensive consensus report including approval likelihood percentage, key findings from each agent, and specific recommendations for improvement.
Understanding Your Results
Approval Likelihood Score
Agent Scores
Each agent provides an individual score based on their domain expertise:
- • Clinical Score: Based on safety data, adverse events, and patient outcomes
- • Operations Score: Based on manufacturing controls, testing, and quality systems
- • Regulatory Score: Based on compliance with FDA requirements and documentation completeness
Best Practices
Complete Documentation
Ensure your submission includes all required sections: device description, intended use, substantial equivalence (for 510(k)), clinical data, and testing results.
Quality Clinical Data
Include comprehensive clinical trial data with clear endpoints, statistical analysis, and adverse event reporting for the best assessment results.
Review Agent Feedback
Pay attention to specific recommendations from each agent. Address critical issues before submitting to the FDA to improve approval chances.
Iterative Improvement
Use Deffai throughout your submission preparation process. Run multiple analyses as you update your documentation to track improvement.
Common Issues & Solutions
Low Clinical Score
Usually indicates insufficient clinical data or unclear safety profile. Add more patient outcome data and adverse event analysis.
Regulatory Compliance Issues
Check that all FDA-required sections are present and properly formatted. Use the FDA's official guidance documents as reference.
File Upload Errors
Ensure your file is under 50MB and in PDF or Word format. Try converting to PDF if you experience issues with Word documents.
Try a Demo Document
Experience the full analysis workflow with our pre-loaded FDA submission examples.
Go to FDA Filing Analysis