Introduction to Medical Software - 2.1 | From Food to Software: The FDA's Evolving Mission & History - Medical Software Course

In this lesson, we dive into the fascinating history and crucial mission of the FDA, exploring how this vital agency evolved from regulating food and drugs to overseeing complex medical software. We'll examine the landmark events, like the Therac-25 disaster, that propelled the FDA into its current role, emphasizing the core principles of efficacy, safety, and security that guide its oversight of medical software products. 🎯 Learning Objectives • Explore the historical evolution and core mission of the FDA. • Understand how major incidents like the Therac-25 accidents shaped medical software regulation. • Define the critical principles of efficacy, safety, and security as applied by the FDA to medical devices and software. • Identify the scope of FDA regulation for different types of software.