This course examines the operational, strategic and commercial aspects of the regulatory approval process for new medical devices, biologics, and combination products in the United States. The topics are designed to provide a chronological overview of the requirements needed to seek marketing approval. The goal of this course is to introduce and familiarize students with the terminology, timelines and actual steps followed by Regulatory Affairs professionals employed in the medical device, pharmaceutical, or biotechnology industry. Case studies from industry will be examined to supplement certain topics and to illustrate interpretation of regulations.
Prerequisite of ALS 362
After completing this course, students should have:
- 1.A fundamental knowledge of acronyms and terminology that are used in the FDA regulatory approval process from the design input stage through submission and review of the 510(k) or Pre-Market Approval documentation and post-market approval requirements for a new medical device.
- 2. Comprehension of the documentation and regulatory requirements necessary at each stage of the U.S. regulatory submission and review process for medical devices and biologics.