In this lecture from Yale's Introduction to Medical Software, the instructor traces the history and evolving mission of the FDA, explaining how an agency originally focused on regulating food and drugs came to oversee complex software used in medical devices and clinical settings. The session situates current medical software regulation within this longer institutional history, helping students understand why the agency's frameworks sometimes reflect assumptions built for physical products rather than software. Understanding this evolution gives students context for the specific guidance documents and approval pathways covered later in the course. The lecture is aimed at students who want to understand not just what the rules are, but why the regulatory system for medical software developed the way it did.