FDA Submissions Using AI Tools: Ensuring Regulatory Success

Course Description

Formerly "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 using traditional and new AI tools. Students should already have a foundation in medical device terminology 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 AI tools 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
• PMA
• Panel and Pre-submission preparation
• Software, Artificial Intelligence, and Digital Health Submissions
• Warning letter responses
• eSTAR submissions
• Use of artificial intelligence tools
  

   

Prerequisites/Skills Needed

• REGL.X410 - Foundations in Medical Devices, or equivalent experience

Additional Information

In order to obtain maximal benefit, this hands-on course requires substantial out-of-class work crafting a 510(k) submission project. You will have free access to subscription-only artificial intelligence tools. Please plan your course schedules accordingly.

AI* - This course integrates AI throughout the curriculum. The focus will be on using AI as a tool for sorting through predicates, and selection of tests necessary to gain your device’s approval/clearance from the FDA. We will use AI to build content, with heavy emphasis on learning to differentiate between AI hallucinogenics and actual truth.