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FDA Takes Initial Steps To Quantify Patient Opinion

CDRH survey to quantify patients’ risk tolerance for obesity device therapies will begin soon, but some physicians and patient advocates are urging caution in applying the data.

CDRH is pressing forward with a strategy to quantitatively measure patient opinion and use it to help inform benefit-risk decisions in developing and approving devices. But both physicians and patient groups, while offering general support for the initiative, are warning the device center to proceed cautiously.

The first target for the project is obesity devices, as center officials described at a May 18 meeting at the agency’s main campus in Silver Spring, Md. Since last year, CDRH has been preparing for a survey of patients’ attitudes about obesity and the trade-offs they are willing to make to undergo device therapy. (See Also see "Obesity Devices: Planned Risk-Tolerance Survey Could Impact CDRH Decision-Making" - Medtech Insight, 16 January, 2012..) The center published a Federal Register

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