AI/ML

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Earlier this week, the U.S. Food & Drug Administration (“FDA” or the “Agency”) released its long-anticipated final guidance (the “Guidance”) on predetermined change control plans (“PCCPs”) for devices that utilize artificial intelligence/machine learning (“AI/ML”) software. FDA’s stated goal for the Guidance is to “to provide a forward-thinking approach to promote the development of safe and effective AI-enabled devices,” and it represents notable progress in the Agency’s scramble to keep with – or at least prevent being too far outpaced by – the rapid pace of AI/ML innovation, as used in digital health technology.Continue Reading FDA Releases Long-Anticipated Guidance on Predetermined Change Control Plans for Devices That Utilize AI/ML Software

The US Food and Drug Administration (FDA) published an Action Plan for artificial intelligence (AI) and machine learning (ML) software on January 12, 2021 that provides near-term actions to develop a regulatory framework for AI and ML-based medical devices.  The quick takeaway is that FDA will publish a draft guidance on change control plans, a key concept from its April 2019 discussion paper on AI/ML-based software devices (previously reported here). FDA also will hold a public workshop on algorithm transparency and engage its partners and stakeholders on other key initiatives, such as evaluating bias in algorithms. While the Action Plan proposes a roadmap for advancing a regulatory framework, an operational framework appears to be further down the road.
Continue Reading FDA’s Action Plan for Artificial Intelligence: Highlights and Insights for Developers