Even before the Biden administration issued a landmark executive order on October 30, 2023, establishing new standards for artificial intelligence (AI) safety and security, 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.
The 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.
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