This course is designed to provide individuals with pragmatic knowledge of how to craft medical device submissions for approval by the FDA. Students should already have a foundation in medical device terminology, classification, and regulations prior to taking this course. Through lectures, case studies, and hands-on exercises, new and experienced regulatory professionals learn how to work with the regulations, guidance documents, and style guides to write portions of key medical device submissions that both comply with the requirements and are clear to the reviewers. Students explore the content and process of medical device submissions, as well as gain insight into timelines, important strategic considerations and business impacts.

Learning Outcomes

At the conclusion of the course, you should be able to

• Find the required regulations and guidance documents for device and diagnostic submissions
• Use regulations and guidance documents to outline and construct a variety of device submissions
• Appreciate the role that regulatory strategy play in the submissions process, for US device submissions

Topics Include

• 510(k)s: Traditional, special, abbreviated
• PMA
• Panel and Pre-submission preparation
• Software, Artificial Intelligence, and Digital Health Submissions
• Warning letter responses
• eSTAR and ecopy submissions

Additional Information

In order to obtain maximal benefit, this hands-on course requires substantial out-of-class work on a submission project, where you will be crafting a 510K. Please plan your course schedules accordingly.