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Regulatory Science/The Science Board/Standard Development

The 4th Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning

Press Release

February 20, 2023 from 2pm to 4pm
Given the impact of COVID-19, the conference was held online.

Agenda / List of Handouts

Agenda
  1. Study on Issue of Report
    • Way of Reuse of Data
    • Terms Required for Data Assessment
    • Way of Examination of Adaptive AI
  2. Others
 
List of Handouts
  • Document 1 Summary of Discussions at the 3rd Working Group
  • Document 2 Script of Post-market Change of Performance
  • Document 3 Topic Note of Discussion (January 23, 2023)
  • Document 4 Modality-specific Situation of Database
  • Document 5 Agenda and Draft of Report (Repost of the 3rd Subcommittee)