2022 - FDA Regulation of Artificial Intelligence/ Machine Learning

OVERVIEW
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
FDA has regulated medical software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidances.
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.
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.
WHY SHOULD YOU 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.
AREA COVERED
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
SPEAKER PROFILE
Edwin Waldbusser, is a consultant retired from industry after 20 years in management of development of medical devices (5 patents).
For more detail, please click on this below link:
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Email: info-AT-247compliance.us
Tel: +1-661-336-9555
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