NESTcc Partners with Booz Allen Hamilton for Active Surveillance in Medical Devices

Background

NESTcc and the FDA intend to develop and implement an active surveillance system of electronic health data to better understand the safety of medical devices as used within clinical practice. Once realized, such a system will optimize data collection, quality, completeness, and analysis within a comprehensive framework to assess potential and ongoing safety signals in a timely manner. The active surveillance program is focused on achieving better data capture, detection of potential safety signals, and a timely assessment leading to actionable findings. In addition, the data structure developed for the active surveillance system will be viable for generation of real-world evidence fit for purpose for regulatory decisions. This selection is in response to NEST’s RFP 23-AS1001 which was issued in July of this year.

About the National Evaluation System for health Technology Coordinating Center (NESTcc)

In 2016, the U.S. Food and Drug Administration (FDA) awarded the Medical Device Innovation Consortium (MDIC) funding to establish the National Evaluation System for health Technology Coordinating Center (NESTcc). NESTcc is advancing the use of real-world evidence (RWE) in medical devices for regulatory decision-making and committed to transforming the way medical device technologies are tested, approved, and monitored. The Coordinating Center combines RWE system infrastructure with the unparalleled expertise of its network collaborators to accelerate patients’ access to safe and effective medical technology and provide Quality Evidence by Design™. For more information, visit http://www.nestcc.org.

About the Medical Device Innovation Consortium

At MDIC, we unite in a shared mission to improve health and save lives by accelerating access to medical technologies. Through stakeholder collaboration, MDIC leads the way in advancing the scientific and technical foundations of medical device design, manufacturing, regulation, reimbursement, and clinical integration. Founded in 2012 as a nonprofit, public-private partnership to elevate regulatory science, MDIC develops new approaches and tools for addressing shared challenges among medical device manufacturers, researchers, regulators, payers, patients, and health care providers. We deliver high impact work in the core areas of quality design and manufacturing, evidence generation, digital technology and transformation, and patient engagement. To learn more and join us in our mission, visit MDIC.org.

Funding for NESTcc was made possible, in part, by the Food and Drug Administration through grant (U01 FD 006292). Views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.