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Risk And Benefit, Quantified: CDRH Expands Use Of New Statistical Framework

Decision analysis tools will be put into practice as part of the device center’s priority “innovation pathway” for breakthrough devices and in a pilot program focused on obesity devices. The techniques may allow for shorter development and review cycles, among other benefits, CDRH says.

CDRH is taking near-term steps to expand the number of decisions made in the center that are guided by a new statistical framework used to quantify risks and benefits.

The goal, the device center says, is to better standardize and quantify the decision making, potentially allowing for shorter development...

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