Device Cybersecurity Program News Today

To embed, copy and paste the code into your website or blog: On January 12, 2021, the U.S. Food and Drug Administration (FDA) released the Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan (Action Plan). The Action Plan expresses that the “FDA’s vision is that, with appropriately tailored total product lifecycle-based regulatory oversight, AI/ML-based Software as a Medical Device (SaMD) will deliver safe and effective software functionali...

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 (AP)Premium The Action Plan furthers and builds on concepts covered in a discussion paper released in April 2019 Share Via Read Full Story 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 intelli...

To embed, copy and paste the code into your website or blog: On January 12, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) Digital Health Center of Excellence released its new five-part “Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan ,” which describes the agency’s efforts to regulate products that incorporate AI. It is a direct response to stakeholder feedback to the April 2019 discussio...