Obesity Devices: Planned Risk-Tolerance Survey Could Impact CDRH Decision-Making
This article was originally published in The Gray Sheet
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.
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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.
Higher-risk devices, based on feasibility trial adverse event rates, would be matched to steeper effectiveness targets in pivotal studies for weight-loss under a plan outlined by the agency.
Device center reviewers will begin applying the guidance to incoming PMA and de novo submissions and to submissions already under review with decisions beginning on May 1.