The federal Food and Drug Administration’s planning board (Planning Board) for a medical device evaluation system (NMDES) recently recommended the creation of a centralized Coordinating Center to develop a national system to evaluate medical devices. Convened in 2014 by the U.S. Food and Drug Administration and the Brookings Center for Health Policy, the Planning Board emerged out of an FDA action plan in 2012 seeking to strengthen the medical device post-market surveillance system by building a more coordinated and efficient system that would track medical devices and share evidence regarding safety and efficacy.
In the report, issued on April 5, 2016, NMDES is described as a voluntary, coordinated network of partnerships that include government agencies, device manufacturers, provider organizations, health plans, and patient communities that share the common goal of “generating higher quality data and evidence at lower costs to inform and improve patient care.” The Coordinating Center proposed by the Planning Board would be responsible for governing, coordinating, and standardizing efforts among these participants. The Coordinating Center would not have explicit regulatory authority, but FDA’s authorities could authorize and initiate activities through the Coordinating Center.
NMDES as a Coordinated Network of Partners
This proposed network would build on the currently-existing limitations in obtaining evidence regarding medical devices, such as the absence of a broad adoption of unique device identifiers (UDIs) for tracking purposes, the expense of manual data entry and delays in data extraction, and limited participation in medical device tracking experts by health care providers and patients.
Although the Coordinating Center should be able to meet its objectives of optimizing data sharing, promoting best practices for device evaluation, and developing a process for disseminating safety and efficacy information, the proposed plan still has several hurdles to overcome. Under the timeline proposed in the report, it is “unlikely that a de novo entity can be organized.” Therefore, the Coordinating Center would have to be incubated at an “established hosting entity” with the plan to spin off the Coordinating Center and Governing Board into a “financially stable and independent entity.” Additionally, there is little concrete discussion of the source of early seed funding. Until such organizational and funding details are determined, NMDES and the Coordinating Center will remain aproposed system; however, as the report is the first in a series of papers to be released by the Planning Board, we expect more information to be forthcoming.
M. Leeann Habte & Lindsey E. Gabrielsen of Foley & Lardner LLP
