In this lecture from Yale's Introduction to Medical Software, the instructor consolidates the course's regulatory material into a practical guide to the approval process for medical software, covering key considerations from initial design through market clearance. The session reviews how classification, risk level, and intended use determine which regulatory pathway a piece of software must follow, and highlights common points of confusion for teams navigating the process for the first time. It draws together the FDA history, validation principles, and device regulation covered in earlier lectures into an applied walkthrough. The lecture is intended to leave students with a clear mental model of how a medical software product actually moves from concept to legal market approval.