In 2014, the U.S. Food and Drug Administration’s (FDA) tasked a multi-stakeholder group with representation from patients, clinicians, researchers, provider organizations, health plans, industry, and experts in health information systems, as well as key government agencies, including FDA, NIH, AHRQ, CMS, and ONC, with the goal of creating a long-term vision for a sustainable national system to evaluate the risks and benefits of medical devices. The Planning Board released its initial report, Strengthening Patient Care: Building an Effective National Medical Device Surveillance System, in February 2015.
In late 2015, FDA asked the Duke-Margolis Center for Health Policy to reconvene the Planning Board to help lead the next phase of the system’s coordinating center and governing body development. The Planning Board released its final series of papers in 2016 to promote and support public discussion of how to address the pressing need and opportunities for better evidence on medical devices.
While the Planning Board’s work is now complete, Duke-Margolis continues to support NEST through expert workshops and exploring acquisition and use of real-world data.
*NEW* The National Evaluation System for health Technology (NEST): Priorities for Effective Early Implementation (September 2016)
Better Evidence on Medical Devices: A Coordinating Center for a 21st Century National Medical Device Evaluation System
While this project is supported through a cooperative agreement with FDA, the views expressed in these papers are those of the Planning Board members, and do not necessarily reflect the official policies of the Department of Health and Human Services, nor does mention of specific projects or organizations imply endorsements by the U.S. Government or other organizations.
Mark B. McClellan
Director, Duke-Robert J. Margolis, MD, Center for Health Policy and Robert J. Margolis MD Professor of Business, Medicine and Health Policy
Gregory W. Daniel
Deputy Director, Duke-Robert J. Margolis, MD, Center for Health Policy and Clinical Professor,
Fuqua School of Business, Duke University
Heather M. Colvin
Project Director, Duke-Robert J. Margolis, MD, Center for Health Policy, Duke University
Christina E. Silcox
Research Associate, Duke-Robert J. Margolis, MD, Center for Health Policy, Duke University
Jonathan M. Bryan
Research Assistant, Duke-Robert J. Margolis, MD, Center for Health Policy, Duke University
Senior Research Assistant, Duke-Robert J. Margolis, MD, Center for Health Policy, Duke University