U.S. Food and Drug Administration main campus building.
The U.S. Food and Drug Administration (FDA) recently announced it would develop a new review framework for AI and machine learning-based medical devices.
Currently, a medical device’s algorithm has to be “locked” by the manufacturer before it is given approval by the FDA. “Locked” algorithms provide the same result each time the same input is given, while an adaptive algorithm, which utilizes AI, changes its behavior using a defined learning process.
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