What Happened
The FDA and College of American Pathologists expanded their guidance on evaluating digital pathology systems, focusing on reader study design and AI-assisted workflows.
Key Points
- Emphasises prospective reader studies with balanced case mixes.
- Requires documentation of algorithm drift monitoring and revalidation triggers.
- Aligns quality metrics with CLIA expectations for primary diagnosis.
Why This Matters
Helps me align the learning path and project validation checklists with current regulatory expectations. I will adapt the technical notes on AI evaluation to incorporate the new monitoring recommendations.