Regulatory Issues Surrounding Approval of Biomedical Devices
- Understand current US FDA regulatory system and submission pathways for medical devise applications for approval or clearance
- be aware of country-specific requirements in major global markets and how they compare to teh US
- Identify and effectively communicate important messages in written and oral regulatory communications
- Describe emerging or current key areas and priorities in Regulatory Science that relate to regulatory submissions
Medical devices are developed, manufactured, and distributed in a highly regulated environment. This course primarily concerns the processes for obtaining FDA marketing approval or clearance for biomedical devices. Prior to marketing a medical device, governmental approval or clearance is required depending on the type of device and the risk associated with the device. This course is part of a three-course series dealing with various aspects of regulatory science of medical devices. Regulatory processes for class II and III devices, including combination devices, are covered with specific focus on 501(k) and PMA requirements; a section on Emergency Use Authorization (EUA) has also been added. Approval requirements in the EU, Japan, China, and other regions will also be considered. Throughout the course, emphasis will be placed on regulatory science, regulatory strategy and principles of interacting with regulatory agencies.
Topics Covered:This course introduces students to both an overview and the specifics of regulatory science with respect to marketing medical devices, including:
- FDA history
- Medical device classification
- 501(k) and PMA regulations, content, strategies, and processes
- Emergency Use Authorization (EUA)
- FDA guidances and meetings
- Regulation of combination devices and pediatric devices (including HDE and HUD approvals)
- global regulatory structures and processes
Applied / Theory:
Web Content:Syllabus, grades, quizzes, homework assignments, WebEx.
Homework:Homework or quiz assesments will occur approximately weekly
Projects:A project will be required. Further details will be provided during the course; projects in past classes have included a group presentation to a mock FDA panel.
Textbooks:Official textbook information is now listed in the Schedule of Classes. NOTE: Textbook information is subject to be changed at any time at the discretion of the faculty member. If you have questions or concerns please contact the academic department.
Tentative: No required text. Informational class handouts, links to assigned reading and in some cases, prerecorded lectures will be provided.