fda_ai_assessment
Evaluate FDA regulatory requirements for AI/ML-based Software as a Medical Device (SaMD). Classify the device, determine regulatory pathway, and ensure compliance per FDA AI/ML Action Plan.
Instructions
Evaluate FDA regulatory requirements for AI/ML-based Software as a Medical Device (SaMD). Determines device classification, regulatory pathway, and compliance requirements per FDA AI/ML Action Plan.
Input Schema
| Name | Required | Description | Default |
|---|---|---|---|
| system_name | Yes | Name of the AI medical device or SaMD | |
| intended_use | Yes | Intended use statement for the AI system | |
| ai_model_type | Yes | Type of AI model (e.g., static, adaptive, continuous learning, reinforcement learning) | |
| clinical_context | Yes | Clinical context (e.g., diagnosis, treatment, screening, monitoring) |