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FDA Proposes Sliding-Scale Paradigm For Obesity Device Trials

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.

CDRH has developed a novel risk-based strategy for designing pivotal trials for weight-loss devices, with plans to set the effectiveness endpoints based on adverse event rates observed in feasibility studies.

An FDA advisory panel signaled overall support for the vision, though the outside advisers told agency officials earlier this month that some revisions to the proposal would be necessary.

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