• FDA Regulation of Artificial Intelligence/ Machine Learning Software following the new draft Guidance
  • FDA Regulation of Artificial Intelligence/ Machine Learning Software following the new draft Guidance

    • Speaker : Edwin Waldbusser
    • Session Code : EWOCT2423
    • Date : 24th October 2023
    • Time : This Event is Over and the Recorded Content is Available
    • Duration : 75 Mins



Artificial Intelligence (AI) and Machine Learning (ML) are fast becoming game-changers in the medical field. They offer ways to diagnose and treat illnesses more effectively and efficiently. Yet, there's a challenge: The FDA has rules for medical software, but AI/ML doesn't fit neatly into them. Here's why: the FDA usually approves a final, tested version of software. But the whole idea behind AI/ML is that it keeps learning and changing after it's released. If it changes too much, technically, it might need new FDA approval. Imagine having to get that every time your AI learns something new! It's just not practical.

To address this, the FDA released a new draft guidance in April 2023. This guide aims to clarify how AI/ML can fit into the approval process. In this webinar, we'll break down this new guidance. We'll explain the basics of AI/ML, why the old rules don't quite work, and what the new guidelines say.

This isn't a technical webinar. Instead, it's about understanding the new rules and how they affect the medical field.

Plus, attendees will get a handy checklist and outline to keep track of the main points. Join us to get a clear view of where AI/ML stands in the eyes of the FDA!


Attendees will receive a comprehensive outline and checklist to help navigate the complex regulatory landscape.


Areas covered during the session:

  • FDA Discussion Paper on device AI/ML and Action Plan
  • Database management
  • QC of datasets
  • Algorithm updating
  • Reference standard development
  • Standalone performance testing
  • Clinical performance testing
  • Emphasis on “explainability”
  • Additional labeling requirements
  • Cybersecurity


  • FDA discussion paper
  • Checklist for submission (now and future)


Why should you attend?


Join our webinar to gain clarity on the approval process for AI/ML programs, which can be challenging due to the limitations of current regulatory requirements. We'll discuss the FDA's approaches for AI/ML regulation in 2023, as outlined in the new draft guidance.

By attending this webinar, you'll gain valuable insights into the necessary submission documentation and better understand how to navigate the evolving regulatory landscape for AI/ML in medicine.


Who will benefit?

  • Healthcare and life sciences professional that rely heavily on AI/ML applications for diagnosis, treatment, and research will gain valuable insights into regulatory compliance.
  • Regulatory and compliance specialists
  • AI/ML developers and researchers
  • Legal and risk management professionals
  • Medical device manufacturers
  • Quality Professionals

Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 11 years.

Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.

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Tags: FDA, AI/ML, Draft Guidance, Medical Software, AI Regulation, Machine Learning, Webinar, Compliance, Edwin, Waldbusser, October 2023, Webinar