FDA Regulation of Artificial Intelligence/ Machine Learning

Live Webinar

  • 60 minutes
  • 13 Days Left
     Jul 29, 2020
  •   01:00 PM - 02:00 PM ET
    10:00 AM - 11:00 AM PT

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical software by means of regulation and guidance’s for years, however, AI/ML programs fall outside the scope of these regulations and guidance’s. This happens because FDA approves the final, validated version of the software. The point of AI/ML is to learn and update following deployment to improve performance. Thus the field version of the software is no longer the validated approved version.

We will discuss the current regulatory requirements, how they don’t control AI/ML adequately, and approaches FDA is considering for regulation in the near future. Your development program should conform to these concepts now because, with some modifications, they will probably become regulations 

This webinar is not a programming course but will explain the present and future regulatory requirements for AI/ML

Join this session with expert speaker Edwin Waldbusser, where he will discuss about the current Regulatory requirements, documentation requirement, algorithm updating. He will also do discussion of possible future regulation, he will discuss, based on recently approved De Novo applications, how to get your AI/ML program approved now. Necessary submission documentation will be explained.

Session Highlights:

This webinar will cover the following topics.

  • Total product life cycle approach to AI/ ML design

  • Application of FDA software Pre Cert program to AI/ ML

  • FDA discussion paper on AI/ML

  • 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

Why You Should Attend:

It is not clear how to get AI/ML programs approved. The current regulatory requirements don’t control AI/ML adequately.

We will discuss the approaches FDA is considering for regulation in the near future and how to get your AI/ML program approved by FDA now. Necessary submission documentation will be explained

Attendees will receive a multipage outline and checklist.

Who Should Attend;

  • Software Engineers

  • Engineers

  • Regulatory personnel

  • Quality Assurance personnel

  • Marketing

  • Management

You may ask your Question directly to our expert during the Q&A session.

** You can buy On-Demand and view it as per your convenience.

Edwin Waldbusser

Edwin Waldbusser

Ed retired from industry after 27 years in management of development of medical device products and development of company Quality Systems.  He has been a consultant for the last 9 years, working with companies from startups to Fortune 100 in the US, Germany, United Kingdom,Netherlands, Canada, Poland and Saudi Arabia. He specializes in design control, risk analysis, human factors, software validation, and supplier qualification/ control.

Ed has a B.S. Mechanical Engineering from NYU and a M.B.A from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents.

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