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Medical Devices / Regulatory Affairs / Postmarket Safety / Research and Development

NESTcc Launches Real-World Evidence Projects With FDA, Devicemaker Giants

Feb. 15, 2018

The National Evaluation System for health Technology Coordinating Center launched 11 demonstration projects, with a $3 million grant from the FDA to explore the use of robust real-world evidence.

Sources of real-word data include administrative claims, electronic health records, as well as patient- and device-generated data.

“The use of real-world data seeks to capture a larger, more representative assessment of device performance while increasing efficiency and lowering costs,” NESTcc said in its description of a demonstration project involving Abbott, Boston Scientific, the American College of Cardiology, LivaNova, Medtronic, the FDA, Duke, and Yale, among others.

The project — Electrophysiology Predictable and Sustainable Implementation of National Registries — seeks to shift away from patient follow-up assessments in post-approval studies towards a RWE approach by leveraging existing sources of data, including EHR data, remote patient monitoring with periodic contact, administrative claims, and patient registries.

The FDA is participating in six of the 11 demonstration projects, while Medtronic is taking part in four.

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