Regulatory Submissions: Devices and Diagnostics

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.

Topics include:

  • 510(k)s: Traditional, special, abbreviated
  • Crafting substantial equivalence justifications
  • Determining testing requirement
  • Modifications to 510(k) devices
  • PMAs and their supplements
  • IDE
  • Warning letters
  • Adverse event reporting
  • Communicating and negotiating with the FDA and internal customers

This hands-on course requires substantial out-of-class work on a submission project, where you will be crafting a 510(k). Please plan your schedule accordingly.

Prerequisites :

Offering code Offering title
REGL.X404 Regulation of Medical Devices and Diagnostics