Artificial Intelligence/Machine Learning Medical Device Regulatory Handbook

Lexology September 12, 2024
Cooley LLP

Artificial Intelligence/ Machine Learning Medical Device Regulatory Handbook by Cooley’s life sciences and healthcare regulatory team

Cooley AI/ML-Based Medical Device Regulatory Handbook

Even before the Biden administration issued its landmark executive order on October 30, 2023, establishing new standards for artificial intelligence (AI) safety and security,1 the US Food and Drug Administration (FDA) had been exploring how to regulate medical devices that incorporate AI and machine learning (ML) and evaluating the role of AI/ML in medical product development.2 FDA has sought to strike a balance between facilitating patient access to innovative medical device technologies and providing oversight in a manner that adequately protects public health. This handbook outlines the key issues to consider as device software manufacturers attempt to navigate...

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