FDA publishes Action Plan to regulate AI and ML based products
- FDA publishes an Action Plan serving as a roadmap to a regulatory framework governing AI/ML based products
- The Action Plan furthers and builds on concepts covered in a discussion paper released in April 2019
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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