Medical Device Development: A QA/Regulatory Overview

Starting with the fall 2009 term, this course will be renumbered as RGA 6202.

A comprehensive and updated analysis of U.S. medical device development and approval requirements, this course features detailed analysis of quality assurance issues and recent regulatory reforms implemented under the Food and Drug Modernization Act (FDAMA), in addition to providing a step-by-step guide through the Center for Devices and Radiological Health (CDRH). Also covered are CDRH's reengineering initiatives and evolving Investigational Device Exemptions, Pre-market Approval, 510(k) application process, and Product Development Protocol development and review processes. The course also provides practical, in-depth analyses on how emerging developments and trends are reshaping medical device regulation in the U.S. On completion of this course, students will be able to demonstrate an appreciation of the subjective and interpretive aspects of the regulations, and an ability to think critically about the interaction between regulatory and development processes.

There are no current sections scheduled for this course number.
Please note that courses have been assigned new numbers beginning with the fall term.
Please check the new course number for course availability.