FDA Panel Meeting To Focus On AI/ML Device Labeling, Transparency
The US agency will host an October public workshop to get stakeholder input in developing a much-anticipated artificial intelligence/machine learning draft guidance.
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Digital Health Roundup, August/September 2021: Record Digital Health Funding Q1-3 Of $21.3Bn, AAOS Highlights, Regulatory Updates
In this roundup of developments in digital health, we highlight the key news and announcements from August and September.
A new guidance document and a promise to hold a public workshop are just two commitments made by the US agency in a 12 January action plan aimed at AI/ML-based software as a medical device.
US FDA says as artificial intelligence and machine learning offer new opportunities to improve patient care, the agency hopes to encourage innovation by developing a draft guidance on the issue for sponsors. It also released a discussion paper outlining key issues it wants feedback on from industry and other key stakeholders.