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

NESTcc Selects 11 Projects for Medical Device Real-World Evidence Use Cases

Feb. 13, 2018
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In support of the FDA’s plan to increase the use of real-world evidence in medical device regulatory decision-making processes, the National Evaluation System for health Technology Coordinating Center launched 11 demonstration projects.

NESTcc — established by the Medical Device Innovation Consortium in 2016 with a $3 million grant from the FDA to explore the use of robust RWE — chose the projects for their “potential to provide proof of concept for innovative and scalable approaches” to generating real world evidence across the medical device total product lifecycle.

Under a new five-year cooperative agreement with the FDA, NESTcc received an additional $6 million in funding from device user fees this fiscal year in support of the RWE commitments made in the latest reauthorization of MDUFA.

The selected 11 demonstration projects, expected to be completed by year’s end, will shed light on challenges and lessons learned in the design and execution of RWE studies, and will identify gaps where NESTcc can help accelerate the use of medical device RWE to “support regulatory, coverage, patient, and clinical decision-making,” said NESTcc Executive Director Rachael Fleurance.

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