Regulatory Submissions: Devices and Diagnostics | REGL.X405
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.
- 510(k)s: Traditional, special, abbreviated
- Strategic development of Indications for Use statements
- Crafting substantial equivalence justifications
- Determining testing requirement
- Modifications to 510(k) devices
- PMAs and their supplements
- Warning letters
- Digital Health & Artificial intelligence and their regulatory pathways
- 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.
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