Novel Device Classification
Analyze De Novo precedents across device categories to build classification rationale, identify appropriate special controls, and benchmark against similar technology grants.
De Novo Classification Intelligence
Chart the optimal path for novel devices without predicate equivalents using AI-powered classification strategy, evidence planning, and FDA engagement intelligence.
Capabilities
De Novo Pathway Capabilities
Specialized intelligence for novel device classification and first-of-kind regulatory strategy.
Evidence Planning & Gap Analysis
Define performance testing and clinical evidence requirements by analyzing granted De Novo requests, FDA feedback letters, and special controls for analogous device types.
FDA Engagement Strategy
Optimize Pre-Submission meeting strategy, Q-Sub preparation, and FDA communication with intelligence from historical De Novo interactions and review division patterns.
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