The Medical Device Innovation Consortium, a public-private partnership focused on regulatory science with deep FDA involvement, has been busy lately helping to start the Coordinating Center for the Medical Device National Evaluation System for health Technology (NEST), moving its headquarters from Minneapolis to the Washington, DC, area and continuing to facilitate collaborative research and development for better approaches to running medical device clinical trials.
The US FDA recently committed to spend $30m from device industry user fees to pilot NEST as part of the MDUFA IV reauthorization that will roll out at the start of FY 2018, and MDIC has been tasking with setting up the NEST Coordinating Center to get the effort off the group. NEST is envisioned as a network of registries and databased collecting real-world device data that can support device approvals and post-market surveillance
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