Developing the NESTcc Active Surveillance Portfolio

In 2016, the National Evaluation System for health Technology Coordinating Center (NESTcc) was established, in part, to help address the timely and robust identification of safety signals for medical devices.  NESTcc has received dedicated funding from the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) to advance active surveillance activities for medical devices.  FDA Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health released an update to the FDA’s Medical Device Safety Action Plan on November 20, 2018, outlining how NESTcc will be leveraged to more quickly detect emerging safety signals through active surveillance here.

On December 13, 2018, the NESTcc Governing Committee approved the establishment of a small, multi-stakeholder Active Surveillance Task Force to lead these activities and create a blueprint for NESTcc’s active surveillance activities beginning in 2019.  The goal of these first NESTcc active surveillance projects will be to demonstrate the feasibility of deploying active surveillance tools within the NESTcc Data Network, resolving methodological issues and exploring scalability of active surveillance to include a large number of devices.  NESTcc will be launching the Task Force in early 2019, with the blueprint developed by Spring 2019.  Announcements on the Task Force membership will be made in January 2019.

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NESTcc's Test-Case study protocol on synthetic mid-urethral slings for stress urinary incontinence in women is open for public comment through June 12. More: bit.ly/2RM654T pic.twitter.com/fk4ore1Kmg 1 day ago

NESTcc is requesting public comments on the study protocol of our Test-Case focused on synthetic mid-urethral slings for stress urinary incontinence in women. The comment period is open until June 12. More: bit.ly/2RM654T pic.twitter.com/5owFLFq1Fl 1 week ago

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