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FDA publishes Action Plan to regulate AI and ML based products
The FDA has advanced an Action Plan focussed on possible means and methods of regulating AI/ML based products
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The Action Plan furthers and builds on concepts covered in a discussion paper released in April 2019
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On 12 January 2021, the US Food and Drug Administration (FDA) published a five part action plan which provides short-term actions to regulate products that incorporate artificial intelligence and/or machine learning (AI/ML). This Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device Action Plan was released by the Digital Health Centre of Excellence (DCE). The DCE launched on 22 September 2020 and exists within the FDA s Centre for Devices and Radiological Health. The DCE s aim is to further the FDA s overarching dedication to the advancement of digital health technology. ....

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