
Andy Coravos gives an overview of US regulatory agencies and their role in overseeing devices (SaMDs) and how to submit public comment to these agencies. Mark Shervy gives an overview of institutional review boards (IRBs) for research with human subjects. Speakers: Andy Coravos, Mark Shervey Lecture 22.1: Regulation of ML/AI in the US slides (PDF - 2.9MB) Lecture 22.2: Human Subjects Research slides (PDF)