Regulatory Issues Surrounding Approval of Biomedical Devices
Learning Objective:See Description
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 in the US, a specific 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. Regulatory processes for class I, II, and III devices, including combination devices, are covered with specific focus on 510(k) and PMA requirements. Approval requirements in the EU, Japan and other countries will also be briefly considered. Throughout the course, emphasis will be placed on regulatory science, regulatory strategy and principles of interacting with regulatory agencies.
Spring 2015 Syllabus
Topics Covered:This course introduces students to both an overview and the specifics of regulatory science with respect to marketing medical devices, including: 1) FDA regulatory classification 2) 510(k) and PMA regulations, content, strategies, and processes 3) Labeling and claim language 4) Regulation of combination devices and pediatric devices 5) HDE and HUD approvals 6) Standard Technical Documents (STeDs) and Clinical Evidence Reports (CERs) 7) Product approval regulations outside the US; and 8) Post-approval requirements (e.g., filing decisions, annual reports).
Applied / Theory:
Web Content:Syllabus, grades, quizzes, homework assignments, WebEx.
Homework:There are 12 to 13 assessments (not quite 1 per week), in either written or online quiz format, that are submitted in the online learning environment Blackboard Learn.
Projects:There is a group presentation to a mock panel. Distance students participate via the Internet via webinar software, or other similar means.
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.