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CDRH Prioritizes Leveraging Real-World And Patient-Preference Data, Enhancing Quality

This article was originally published in The Gray Sheet

Executive Summary

In its 2016-2017 strategic priorities, the device center lays out specific goals for putting more emphasis on real-world postmarket data to support regulatory decisions, making better use of patient-preference input, and enhancing quality at CDRH and in industry. Topping FDA's list: gaining access to 25 million electronic patient records with device identification from global registries, insurance claims data and electronic health records, and expanding that number to 100 million by the end of 2017 to support premarket and postmarket decisions.

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