FDA has been working closely with industry and other stakeholders for years to develop a framework for a National Evaluation System to better monitor long-term safety and effectiveness of medical devices. However, Center for Devices and Radiological Health Director Jeff Shuren says if the agency can't get assurance of future funding for the program this year, the system may not get up and running until fiscal year 2023.
Shuren: FDA Willing to Kick-Start Device Evaluation Program, But Funding Guarantee Needed
CDRH Director Jeff Shuren says FDA is willing to foot the bill for a coordinating center to help launch a new "national device evaluation system," but it is contingent on a guarantee that the program would be funded by the upcoming user fee reauthorization.