AI-powered guidance on FDA and EU IVDR classifications from your concept and intended clinical purpose.
Informational guidance only. Not legal or regulatory advice.
Advanced AI searches regulatory databases and analyzes similar devices to provide accurate classification guidance.
Get comprehensive estimates for both FDA (Class I/II/III + pathway) and EU IVDR (Class A/B/C/D) in one assessment.
Upload your PRD, specs, or pitch deck and let AI extract answers automatically to speed up the assessment.
Complete a multi-step questionnaire about your device concept, clinical intent, risk factors, and intended use. Upload documents to auto-fill answers with AI.
Receive intelligent FDA and IVDR classification estimates with AI analysis of similar approved devices and regulatory precedents.
View actual timelines and costs from similar device approvals with links to FDA and IVDR databases for verification.
Use AI to identify candidate FDA product codes and get IVD-specific risk indicator suggestions based on regulatory precedents.
FDA Class I/II/III Estimate
AI-powered risk-based classification
Likely Pathway (510k/De Novo/PMA)
Based on similar device precedents
IVDR Class A/B/C/D
Deterministic Annex VIII rule engine
Timeline & Cost Ranges
Evidence-based from historical approvals
Confidence Scoring
Know what info would increase accuracy
AI Product Code Search
Real FDA database queries with GPT-4
Similar Device Analysis
Find comparable approved devices
Next Steps Guidance
Clear action items for each pathway
This tool provides informational guidance only. It is not legal advice, regulatory advice, or an official classification determination.
All estimates are based on AI analysis and limited information provided. Actual classifications depend on complete device specifications and review by regulatory authorities.
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