FDA Guidance Eases Burden for AI-Enabled Medical Device Changes

The FDA aims to boost the development of AI-enabled medical devices and software by sharing how it will ease review of changes to such products to ensure they remain safe and effective.

A final guidance from the Food and Drug Administration published in December addresses how the agency will speed along manufacturers’ submission of iterative, or minor, changes to medical software using artificial intelligence and machine learning in medical devices—such as wearable health monitors that track patients’ vital signs, electronic stethoscopes, and surgical robots—while protecting patients and their data as these devices evolve.

AI-enabled medical devices, which derive new data ...