Five highlights from FDA's new AI device regulation Action Plan | Hogan Lovells
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 discussion paper , “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Lear...