News Feature | September 23, 2016

FDA Planning Board Unveil Priorities For Coordinating Center Overseeing Device Evaluation System

By Jof Enriquez
Follow me on Twitter @jofenriq

FDA Draft Guidance

A Planning Board convened by the U.S. Food and Drug Administration (FDA) and the Duke-Margolis Center for Health Policy laid out the initial priorities for the proposed Coordinating Center in charge of the National Evaluation System for Health Technology (NEST).

As the national evaluation system for medical devices, NEST aims to generate evidence across the total product lifecycle of medical devices – including integrating real-world evidence from clinical registries, electronic health records, and medical billing claims – in order to track device safety and effectiveness.

By "leveraging clinical data and applying advanced analytics and flexible regulatory approaches tailored to the unique data needs and innovation cycles of specific device types, a more comprehensive and accurate framework could be created for assessing the risks and benefits of devices," FDA Commissioner Dr. Robert Califf and Dr. Jeffrey Shuren, director of FDA’s Center for Devices & Radiological Health (CDRH) said in July.

To lead NEST, the Planning Board in April proposed the creation of an independent Coordinating Center, which shall provide governance, coordination, and standardization to organizations within the medical device ecosystem, and to optimize the cost of, access to, quality of, and sharing of data related to the evaluation of medical devices. The Center will have multi-stakeholder representation from patients, health care professionals, health care organizations, payers, the medical device and digital health industries, and the government.

Now, the Planning Board, through a report issued this week, has outlined recommendations on organizational governance such as operational leadership, bylaws, and the creation of a representative governing board for the Coordinating Center. The Planning Board also included priority areas and activities for the strategic development of the Coordinating Center, including data governance and recommendations for high-value demonstration project areas.

These projects are to be aggressively implemented in two phases: phase one within three years, and phase two within five years.

Phase one demonstration projects, which will focus on "regulatory and safety improvements possible with a coordinated approach in analyzing real-world data," aim to achieve:

  • Effective and efficient balancing of pre- and postmarket device evidence development; and
  • Building towards an active surveillance system by improving safety surveillance of medical devices.

Phase two demonstration projects, which will expand on phase one's work "into gaining a greater understanding of medical devices’ value to various stakeholders," have the following goals:

  • Enhancing data collection and integrating health information technology (health IT) systems for improved evaluations of Class 2 devices;
  • Promoting methods for patient-mediated data sharing; and
  • Developing approaches and capabilities within the NEST infrastructure for measuring device value.

"These projects should be used to show the value of the Coordinating Center, build the shared resources of NEST, as well as be an opportunity to test and refine the Center’s foundational priorities, process designs, and governance policies," according to an announcement from the Duke-Margolis Center for Health Policy.