FDA finalizes AI-enabled medical device life cycle plan guidance

The FDA has finalized guidance for the lifecycle management of AI-enabled medical devices, focusing on ensuring safe, effective, and continuous updates. This includes Predetermined Change Control Plans for tracking planned updates, with the ability to make manual or automated adjustments based on new data. These updates aim to improve device perfor...

  • Published date: 05-12-2024 12:00 AM

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The FDA has finalized guidance for the lifecycle management of AI-enabled medical devices, focusing on ensuring safe, effective, and continuous updates. This includes Predetermined Change Control Plans for tracking planned updates, with the ability to make manual or automated adjustments based on new data. These updates aim to improve device performance across diverse patient populations, ensuring devices adapt to clinical needs.