From Food to Software - The FDA's Evolving Mission and History - Medical Software Course 2.1

Explore the historical evolution of the FDA from its origins in food and drug regulation to its current oversight of complex medical software in this 15-minute lesson from Yale University. Examine the agency's core mission and understand how landmark incidents, particularly the Therac-25 disaster, fundamentally shaped modern medical software regulation. Learn about the critical principles of efficacy, safety, and security that guide FDA oversight of medical devices and software, while identifying the scope of regulatory authority across different types of software applications. Discover how major regulatory milestones and technological disasters influenced the development of current safety standards and regulatory frameworks that protect patients from potentially harmful medical software systems.