Risk And Benefit, Quantified: CDRH Expands Use Of New Statistical Framework
By
Rebecca Kern / Email the Author / “The Gray Sheet” Jan. 2, 2012, Vol. 38, No. 01
Regulatory / Word Count: 1906 / Article # 01120102007
Executive Summary
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.
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