Course Description: This 21-hour course meets one day a week for 3 hours, over a 7-week period. A thorough examination of FDA regulations and an overview of equivalent international regulations will be covered. As a result of this training students will be able to describe the mission and organization of the FDA; locate the current laws and regulations that regulate the medical device industry; propose a corrective and/or preventive action?to a not-compliant issue in the medical device industry; describe the different classifications for medical device products and the pre-market pathway appropriate for each device classification; and explain the value of post-market requirements for approved devices (21 CFR: parts 807,821,822)? This course is one of four in the Medical Device Manufacturing Processes and Practices Certificate program. Upon successful completion of the certificate, students will qualify for entry-level positions, including Quality Technician, Quality Inspector, and Quality Assurance Inspector.