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

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.

FDA pledged to continue work on developing a national evaluation system for medical devices, incorporating patient input into device reviews and upping its game on quality management in the Center for Devices and Radiological Health's latest two-year strategic priorities agenda, issued Jan. 13.

The calendar year 2016-2017 priorities build on work the device center is already undertaking, providing dates for when it plans...

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