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FDA Regulation of Artificial Intelligence & Machine Learning

01-October-2021 :01:00 PM EDT Duration : 60 Minutes

Jose Mora,

Jose Mora, is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Co Read more

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 for years, however, AI/ML programs fall outside the scope of these regulations and guidance. This happens because the FDA approves the final, validated version of the software. The point of AI/ML is to learn and update the following deployment to improve performance. Thus, the field version of the software is no longer the validated approved version.

Course Objectives:

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 the FDA now. Necessary submission documentation will be explained.

Why Should You Attend:

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. Following a discussion of possible future regulations, 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.

Course Outline:

• 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

What You Get:

• Training Materials

• Live Q&A Session with our Expert

• Participation Certificate

• Access to Signup Community (Optional)

• Reward Points

Who Will Benefit:

• Software Engineers

• Engineers

• Regulatory Personnel

• QA/QC Personnel

• Marketing Personnel

• Management Personnel

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

Contact Us

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