RGA 6620 — Medical Device Development: A Regulatory Overview
3 semester hoursGraduateLecture
Analyzes and studies how to apply U.S. medical device development, clearance, and/or approval requirements. Examines quality assurance issues and recent regulatory reforms implemented under the Food and Drug Modernization Act, in addition to providing a step-by-step guide through the Center for Devices and Radiological Health. Covers CDRH’s reengineering initiatives and evolving investigational device exemptions, premarket approval, 510(k) application process, and product development protocol and review processes. Provides practical, in-depth analyses on how emerging developments and trends are reshaping medical device regulation in the United States. Discusses the subjective and interpretive aspects of the regulations. Guides students how to think critically about the interaction between statutory, regulatory, and development processes.