November 21, 2024

FDA to address regulatory challenges for generative AI in medtech

In this article:

Regulatory Focus: The FDA will discuss a new framework for regulating generative AI-enabled medical devices at a Digital Health Advisory Committee meeting on Nov. 20–21.
Balancing Act: The meeting aims to explore how to foster innovation while ensuring the safety of these transformative technologies in healthcare.
Growing Adoption: Generative AI is increasingly integrated into healthcare, offering significant benefits alongside complex regulatory challenges.
Lifecycle Approach: The FDA proposes a Total Product Lifecycle (TPLC) framework for oversight, covering premarket evaluation, risk management, and postmarket monitoring.
Industry Impact: The framework aims to address the unique challenges posed by generative AI, shaping the future of medical device regulation.
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FDA to address regulatory challenges for generative AI in medtech

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