A new report from the Duke-Margolis Center for Health Policy is offering an initial peek into a planned coordinating center intended to guide the development and implementation of a postmarket device evaluation system.
The future national medical device evaluation system — one of CDRH’s 2016-2017 strategic priorities — is intended to capture and use real-world evidence to bolster regulatory decision-making. As envisioned, the coordinating center would create opportunities for better evidence generation and sharing with a network of partners.
The report — issued by the planning board for the national medical device evaluation system — provides suggestions on the objectives, tasks and capabilities a coordinating center would handle.
The center’s primary objective would be “to optimize the cost of, access to, quality of, and the sharing of medical device real-world data for evidence development,” the report says.
For example, the center could assist mid-size and small companies to identify analytic tools to run efficient pre- and postmarket trials, as well as studies to back up reimbursement and coverage decisions.
The center could also help solve some policy challenges, such as encouraging UDI adoption, standardizing informed consent and ensuring patient privacy.
The report comes a couple of weeks after a meeting hosted by the FDA and the University of Maryland’s Center of Excellence in Regulatory Science and Innovation that discussed strategies to enhance postmarket data collection ().
The FDA has ramped up efforts towards a national evaluation system over the past couple of years.
In 2014, the FDA tasked experts from government agencies, healthcare delivery organizations and other entities to outline a national system. This planning board unveiled a February 2015 report, authored by experts from the Brookings Institution, to outline some of the proposed system’s activities ().
Late last year, the FDA asked the Duke-Margolis Center for Health Policy to reconvene the planning board to help lead the next phase for the system’s coordinating center and governing body.