Digital Pathology Association's recent regulatory session with the DPA and FDA collaboration at #PathVisions24 was a success!
On stage at this session we had John Groth who is co-chairing the regulatory standards taskforce with @Laura Chang.
Under their leadership, the DPA has been collaborating with the FDA to advance digital pathology through regulations and standards.
Esther Abels presented the key take aways from the EU AIAct:
• Came into force on August 1, 2024
• Intended to protect health, safety, and fundamental rights in the European Union (EU).
• Scope will affect all global industry as well as Health Care Professionals who delivers products, tools and/or services with the use of AI and impact citizens in the EU
• In addition to existing EU harmonized legislation, i.e., on top of EU IVDR
DPA is collaborating continuously with the FDA to enable and enhance interoperability. Soumen Roy, Ph.D. from FDA providing insights in the current Whole Slide Imaging (WSI) regulatory landscape.
Key topics addressed is that some of the benchmark requirements have been modified addressing least burdensome approach:
• WSI: for the pivotal clinical study the sample size has been reduced from ~2000 to ~1000
• Viewer: the pixel wise comparison acceptance criterion for the delta E has been increased form 0 to 3 (95th percentile)
• Display: so far 9 displays were cleared and 1 was associated with PCCP
In case of questions, pls contact Soumen Roy, Ph.D..