US FDA Opinions Vary On AI’s Black Box Issues. Will Uncertainty Follow?

Chief Medical Officer Hilary Marston says a black box model could be a problem for reviewers, after CDER and CBER officials said unexplainable AI models could be acceptable but transparency is important.

Transparency is important with an AI black box, the FDA said. (Shutterstock)

Some US Food and Drug Administration officials may be willing to consider artificial intelligence models that are not fully explainable, but Chief Medical Officer Hilary Marston seems concerned about their use in applications, further illustrating the agency’s ongoing challenge regulating the emerging technology.

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