FDA Regulation of Artificial Intelligence/ Machine Learning

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.

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.

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