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Marcus Schabacker called for more upfront regulations and postmarket monitoring to better understand how AI features affect patient care.
The Food and Drug Administration is grappling with a surge in the number of medical devices that contain artificial intelligence or machine learning features. The agency had authorized 882 AI/ML-enabled devices as of March, and many other devices include AI features that don’t require regulatory review.
Currently, AI is most often used in medical devices in the radiology field, although the technology is also used in pathology, for appointment scheduling and in clinical support tools that pull in a variety of metrics.
The influx of AI in medical devices has raised questions from lawmakers and patient safety groups. Medical...
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