In this lecture from Yale's Introduction to Medical Software, the instructor examines the FDA's General Principles of Software Validation, a foundational guidance document that shapes how medical software is verified and validated before deployment. The session explains the core principles behind software validation as distinct from general software testing, emphasizing the documented, traceable evidence the FDA expects developers to produce. Students learn how this guidance influences practical development decisions, from requirements documentation through final testing, and why validation is treated as a continuous discipline rather than a final gate. The lecture builds on earlier sessions covering the FDA's history and general regulatory approach to medical software.