Dive Brief:

The Food and Drug Administration is seeking public feedback on how to measure and evaluate the real-world performance of artificial intelligence-enabled medical devices.

In the consultation, which began Tuesday, the FDA has posed six sets of questions about ways to perform ongoing, systematic performance monitoring to see how AI behaves in clinical settings.

With the rate of AI submissions accelerating , the FDA is wary of the potential for “data drift” to cause devices to perform worse in the real world than in tests run to support authorization.

Dive Insight:

The FDA’s call for feedback is informed by evidence that the performance of AI-enabled medical devices can change over time. As the agency explained in its

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