FDA releases priorities for national device evaluation system

The FDA, in association with the Duke Margolis Center for Health Policy, released a report yesterday establishing guidelines for the development of the National Evaluation System for health Technology.

The NEST aims to operate as a “cooperative network of partners working to use data, advanced methodologies, and good governance to improve the state of medical device evidence generation,” according to a release from the Duke Margolis Center for Health Policy.

The report comes as the 3rd in a series, outlining recommendations on governance including operation leadership, bylaws and a representative governing board for a center that will be charged with building the NEST.

Previous reports included a proposal that a “coordinating center” be established to develop the shared resources for NEST. Included are proposals for building a voluntary network of data partners with re-usable data use and sharing agreements, supporting a network of methodological expertise and clearinghouse of best practices and establishing a multi-directional communication platforms for both developers and the broader public.

The planning board’s report suggested a 2-phase approach to the projects, with “aggressive timelines” for initiation and completion, with the 1st phase complete in 3 years and the 2nd in 5.

In the 1st phase, demonstration projects will focus on “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,” according to the report.

Phase 2 demonstration projects include enhancing data collection and improving integration of health IT systems for evaluating Class 2 devices, promotive patient-mediated data sharing methods and developing approaches and abilities in NEST’s 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,” Duke Margolis Center for Health Policy planning board members wrote.

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