ADHA 7070 Medical Device Advancement: Navigating the Regulatory Landscape

This course will provide an overview of the U.S. Food and Drug Administration (FDA), explore the history of laws related to medical product development, commercialization, and clinical use, and will consider relevant cases whose decisions have been important in establishing precedents and current guidelines. Governing medical products are the beginning point for regulations that identify how research, development and marketing should be pursued. Reviewing and analyzing the development to commercialization will follow the investigational device exemptions (IDE), premarket approval, 510 (k) application process, and product development protocols and review processes.