Articles and Blogs

On August 18, 2026, the U.S. Food and Drug Administration’s (“FDA”) Digital Health Center of Excellence, within the Center for Devices and Radiological Health (“CDRH”), released a discussion paper seeking public comment on how the agency should approach generative artificial intelligence-enabled (“GenAI”) medical devices. FDA emphasized that the paper is intended for discussion purposes... READ MORE

On October 15, 2018, the National Protection and Programs Directorate (“NPPD”) of the U.S. Department of Homeland Security (“DHS”) and the U.S. Food and Drug Administration (“FDA”) entered into a Memorandum of Agreement (“MOA”) that formalizes a long-standing relationship between the agencies and implements a new framework for increased collaboration, information-sharing and coordination that... READ MORE