• FDA Regulation of Artificial Intelligence/ Machine Learning - New FDA Guidance
  • FDA Regulation of Artificial Intelligence/ Machine Learning - New FDA Guidance

    • Speaker : Edwin Waldbusser
    • Session Code : EWAPR2723
    • Date : 27th April 2023
    • Time : This Event is Over and the Recorded Content is Available
    • Duration : 75 Mins


Explore how AI/ML is transforming medicine by making diagnosis and treatment more accessible and effective while posing unique regulatory challenges. Learn why traditional FDA regulations and guidance for medical device software may not adequately address the evolving nature of AI/ML programs, as they continuously learn and update post-deployment.

In April 2023, the FDA released draft guidance outlining the documentation requirements for obtaining clearance/approval for ML products. Join our webinar to understand ML terminology, the ML development process, and the limitations of current regulations. We'll delve into the details of the draft guidance and discuss its implications for AI/ML in medicine.

Please note that this webinar is not a programming course but aims to clarify current and future regulatory requirements for AI/ML in the medical field.

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

Areas covered during the session:

  • Total product life cycle approach to design
  • Application of FDA software Pre Cert program to AI/ ML
  • FDA draft Guidance and AI/ML discussion paper
  • Database management
  • QC of datasets
  • Algorithm updating
  • Reference standard development
  • Standalone performance testing
  • Clinical performance testing
  • Data enrichment
  • 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 We'll discuss the FDA's approaches for AI/ML regulation in 2023, as outlined in the new draft guidance.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 Regulation, Artificial Intelligence, Machine Learning, Draft Guidance, Edwin, Waldbusser, April 2023, Webinar