Report Outlines New FDA Device Evaluation System, Coordinating Center

Posted 04 April 2016 | By Zachary Brennan 

Report Outlines New FDA Device Evaluation System, Coordinating Center

A national medical device evaluation system planning board, created in part by the US Food and Drug Administration (FDA), released a new report on Monday outlining how it plans to develop such a system and a center to coordinate such efforts.

Both the national medical device evaluation system (NMDES) and the coordinating center are part of a larger goal of FDA’s to expedite the generation and dissemination of reliable medical device data, including real-world evidence, in order to promote public health.


In 2014, FDA and the Brookings Center for Health Policy convened a NMDES planning board made up of patients, clinicians, researchers, provider organizations, health plans, industry, experts in health information systems and key government agencies like FDA, the National Institutes of Health and the Centers for Medicare and Medicaid Services.

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. This is the first of a series of high-level papers to be released by the reconvened board to promote and support discussion of how to address the needs and opportunities for better evidence on medical devices.


According to the new report, NMDES is envisioned as a strategically-driven, coordinated network of voluntary partnerships that include patient communities, government agencies, device manufacturers, institutional data partners and methods partners, all working to generate higher quality data and evidence at lower costs to inform and improve patient care.

Resources in NMDES are expected to include:

  • Data from multiple sources (including electronic health records, claims, registries, patient reported outcomes, clinical trial data, etc.) connected through re-usable, standardized data use agreements that optimize data standardization, expedite project-specific research agreements, and reduce the cost of evidence development through economies of scale
  • A clearinghouse of expertise and advanced methods, tools, standards and best practices (e.g., to detect safety events and to study clinical effectiveness of new technologies for regulatory and reimbursement decisions)
  • A trusted and up-to-date compilation of reliable information on the benefits and risks of medical devices for patients and the broader health community (e.g., safety updates, recall management support, emerging effectiveness information)

“NMDES would be constantly identifying new sources of reliable device data and designing and implementing innovative ways of capturing and combining data from disparate sources while ensuring that federal patient-privacy laws, regulations and ethical standards are maintained,” the report says.

In addition, opportunities exist to provide more valuable, rate-based information on labeled outcomes than currently possible through individual Medical Device Reports and to automate data entry and standardize outcome measures to allow evidence generation for effectiveness (including comparative effectiveness) while minimizing the burden of data collection, the board says.

As envisioned, NMDES will be a flexible, virtual system that builds on and supports existing activities generating evidence on medical devices, as well as evidence relevant to other purposes, such as enhancing quality of care and care coordination.

For industry, the report notes that NMDES would be expected to complement the iterative nature of device development and give manufacturers a faster, more predictable path to approval and reimbursement decisions.

Once products are on the market, NMDES would also provide more cost-effective approaches to developing postmarket evidence, leading to greater confidence among clinicians in the products they use and recommend. Meanwhile, payers would benefit from having better evidence to help make coverage decisions.

Coordinating Center

In order to help establish this NMDES, the Duke-Margolis Center calls for the creation of a coordinating center that, among other things, would optimize the cost of, access to, quality of, and the sharing of medical device real-world data for such evidence development.

“At present, there is a critical public health need to establish a Coordinating Center that will have the ability to act as a long-term and broad-based strategic coordinator of efforts to bring together, organize, evaluate, and secure medical device data,” the report says.

The broader adoption of unique device identifiers (UDIs) to track medical devices, the reduction of manual data entry and less delays in data extraction for use, as electronic records can be more reliably used to support device tracking, will also help this project progress.

“The Planning Board believes that there is an unprecedented opportunity for a more coordinated national approach that addresses the broader needs of patients, clinicians, health care insurers, and medical device manufacturers, as well as FDA,” the report says.

Duke-Margolis Center for Health Policy’s April Report

National Evaluation System

2016-2017 CDRH Strategic Priorities

Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles