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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.

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.

During a May 5 discussion at the Food, Drug and Law Institute's annual conference, Shuren said he has received assurance from FDA Commissioner Robert Califf that the agency will put up the initial funding for a coordinating center that would help build the device evaluation system, which the agency is now calling "NEST

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