Course Detail: WTMD930 - Introduction to FDA Regulations

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.

Select the date you would like to start the class below & then follow the prompts on the yellow buttons to complete the registration process.

STIT Funding available if you are a Utah resident. Please click here to apply!

 Session Information: 24SP-WTMD930-02

Schedule: Class will run from 4/24/24 to 6/5/24 weekly, in-person, from 6:00 pm to 9:00 pm, on Wednesdays at the Miller Campus
Only 8 days until the session starts!
Times: 06:00pm-09:00pm MDT
Cost : $399.00


Name Additional Resources
Brandon Dye

Class Location

Miller Campus
Miller Campus - MCPC, 108
9750 S 300 W
Sandy, UT 84070

Cancellation Policy

A cancellation charge of 100.00% will be assessed on cancellations occurring within 2 days of the start of this session.