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FDA Validates Tool For Incorporating Patient Preferences In Regulatory Decisions

This article was originally published in The Gray Sheet

Executive Summary

A pilot study that explored how much risk patients would be willing to tolerate from a device implant in order to achieve significant weight loss is helping CDRH regulators understand how to accurately and reliably measure patient preferences. The goal is to start incorporating those preferences into regulatory decisions for certain devices, officials explained at a Sept. 18-19 workshop.

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