The Food and Drug Administration (FDA) has been working closely with Industry negotiators and other stakeholders for years to establish a National Evaluation System for medical devices. The goal of establishing such an infrastructure is to generate real world evidence to efficiently monitor the long-term safety and effectiveness of medical devices. In the FDA’s Center for Devices and Radiological Health (CDRH) strategic priorities report for 2016-2017, establishing a National Evaluation System for medical devices is a priority, however according to the CDHR Director, Dr. Jeffrey Shuren the system may not be ready until fiscal year 2023, if the agency cannot secure funding.
According to an article in The Gray Sheet, it mentioned that Dr. Shuren received assurance from the FDA’s Commissioner, Dr. Robert Califf that the agency will provide the initial funding for a coordinating center that would help build the system. However, the money will only be provided if additional funding is forthcoming from Congress or increased user fees, which are being negotiated in the Medical Device User Fee Act (MDUFA IV).