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Obesity Devices: Planned Risk-Tolerance Survey Could Impact CDRH Decision-Making

A planned survey evaluating obese patients’ tolerance for risk fits into a broader initiative by CDRH to reassess, and in some cases rebalance, how it weighs risks and benefits when making regulatory decisions.

CDRH’s approach to balancing the risks and benefits of new obesity devices could change based on the outcomes of an upcoming patient survey by the center.

While the device center is still in the early development stages of the survey, it plans to enroll up to 450 patients to measure how much risk these patients would be willing to tolerate in order to achieve a potential benefit from the devices,

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