FDA AI based SaMD Risk Management
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  • FDA - AI based SaMD Risk Management
  • Level of Concern Document (LCD)
  • Software Description (SDE)
  • AI Expertise (AIE)
  • Device Hazard Analysis (DHA)
  • Software Requirement Specifications (SRS)
  • Training and Test Dataset (TTD)
  • Software Design Specifications (SDS)
  • AI Fairness (AIF)
  • AI Transparency and Explainability (ATE)
  • Traceability Analysis (TRA)
  • Verification and Validation (VAV)
  • Revision Level History (RLH)
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Software Description (SDE)

The classification and description of the AI applications, along with system requirements, benefits & cost analysis and application scope are dealt this category. Furthermore, additional elements as AI assessment approaches, metrics and appropriateness and effectiveness are managed in this category.

Controls related to this risk category are listed as below:

  • SDE 01 - AI Classification

  • SDE 02 - AI System Requirements

  • SDE 03 - AI System Benefits

  • SDE 04 - AI Potential Costs

  • SDE 05 - AI Application Scope

  • SDE 06 - Approaches and Metrics

  • SDE 07 - Metrics Appropriateness and Effectiveness

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Last updated 2 years ago