Master 510(k), PMA, and digital health submissions for FDA approval.
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.
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.
This class is offered in an online synchronous format. Students are expected to log into this course via Canvas at the start time of scheduled meetings and participate via Zoom, for the duration of each scheduled class meeting.
To see all meeting dates, click "Full Schedule" below.
You will be granted access in Canvas to your course site and course materials approximately 24 hours prior to the published start date of the course.
