We’ve certainly made strides: FDA provided the seed funding that helped establish the NESTcc, and we also secured partial industry funding for NEST as part of the latest Medical Device User Fee Agreement (MDUFA IV) with industry. To date, the NESTcc has entered into agreements this year with 12 organizations that represent more than 195 hospitals and almost 4,000 outpatient clinics with access to more than 495 million patient records – which will all be a part of the early data network.

New Funding for NEST


Despite all of the progress we’ve made and the promise of this system, NEST will require considerably more funding to fully meet its tremendous potential. The FDA will continue to put what resources we have into building out this system. That’s why, in September, we allocated an additional $3 million in agency funding to the NESTcc. This new funding for NEST, which was provided in addition to the annual funding allocated by the latest user fee agreement, will allow us to continue supporting demonstration projects, described below, for building out active surveillance capabilities.

However, for NEST to become fully functional and fulfill its promise of helping to ensure safer devices for patients, additional resources are essential. Indeed, funding is the principal barrier to establishing this system. To bridge the gap, the President’s budget for fiscal year 2019 includes a request for an additional $46 million for CDRH to support NEST, as well as to conduct FDA-sponsored post-market studies that address device-specific safety concerns. If this funding becomes a reality, the FDA will continue to work with stakeholders to help make NEST financially self-sustaining in the long term.

Advancing Device Safety Pilots Using NEST

As we work to secure additional funding, we continue to do whatever possible to build out NEST now.

With the FDA’s support, the NESTcc announced this month that it has initiated eight test case demonstration projects using real world data. Some examples of projects to conduct post-market surveillance include testing the feasibility of using patient registries and claims data to evaluate the safety and effectiveness of total joint and knee replacement surgeries; to compare the safety and effectiveness of different tissue closure techniques (staples, sutures, skin adhesives) from wounds resulting from trauma or surgery; and to evaluate the safety of intervertebral body fusion devices used to treat spinal conditions like degenerative disc disease.

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