On October 22, 2020, the U.S. Food and Drug Administration (FDA) will hold a virtual Patient Engagement Advisory Committee meeting on Artificial Intelligence (AI) and Machine Learning (ML) in Medical Devices. The Patient Engagement Advisory Committee provides advice to the FDA on complex issues relating to medical devices, the regulation of devices, and their use by patients.
During this meeting, the committee will discuss and make recommendations on the following topics:
- The composition of the datasets on which the AI/ML software “learns”
- Components of the AI/ML-based device information shared with patients
- Factors that impact transparency and patient trust in AI/ML technology.
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