Course Detail

This course presents an overview of the Design Control process for product development, which is mandated by the Good Manufacturing Practices of the Food and Drug Administration (FDA).  To complement Design Control, market release and post-market surveillance topics are also highlighted.  Additionally, six case studies of device and diagnostic companies are provided for real world examples of how companies deal with device regulation.  During the last hour of every class meeting, students work with the instructor to draft the beginning of a regulatory document, based on an innovative new device the instructor has selected for the semester.  These documents are the Clinical Trial Protocol, Requirements Specification, Risk Analysis, 510(k), and Verification Protocol.

Clinical outcome studies
Product Requirement Specification (PRS)
Design control
Risk analysis
510(k) PMA review
Labeling 
Sterilization
Registration & listing with FDA
Alpha & beta market testing
Regulated advertising
Reporting & tracking
Patent infringement
Exports/imports
State regulations
Company case studies

After completing this course, students should:

• understand and be able to execute the components of the Design Control Process.
• comprehend processes associated with Market Release and Post-Market Surveillance.
• be familiar with history of human subject experimentation, and appreciate the need for subsequent regulation.

Class attendance and discussion   10%    
Group project  I: PRS   20%   
Group project II: risk analysis  20%
Group project presentation  15%
Final exam   35%