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CDRH Launches Patients’ Preference Project

Associate director for science at FDA’s device center highlights ongoing efforts to incorporate more quantitative patient input in device reviews.

The recent FDA user fee law for device makers includes provisions to help incorporate wider stakeholder input in agency decision-making, which should help reinforce CDRH’s recent efforts to gather more substantive views from patients on the risk-benefit trade-offs of medical devices, an agency official said recently.

“We don’t want to just listen to patients and have a non-quantitative way of making sure we incorporate their views,” said Michelle McMurry-Heath, CDRH associate director for science, at a...

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