FDA Regulation of Artificial Intelligence/ Machine Learning

Edwin Waldbusser

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Description :

This training will address the current regulatory requirements, how they don’t control AI/ML adequately, and approaches FDA is considering for regulation in the near future. Development personnel should understand these concepts because, with some modifications, they will become regulations.

It is not clear how to get AI/ML programs approved. Following discussion of possible future regulation, we will discuss, based on recently approved De Novo applications, how to get your AI/ML program approved now.

Necessary submission documentation will be explained.

This webinar is not a programming course but will explain the present and future regulatory requirements for AI/ML. Attendees will receive a multipage outline and checklist

Why Attend :

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

Areas Covered :

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


Target Audience :

Software Engineers


Regulatory personnel

Quality Assurance personnel



Webinar Events
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Edwin Waldbusser, Medical Device

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 areas of design control, risk analysis and software validation for the past 8 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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