Task Force Advocates Making Registries Better Than Sum Of Their Parts
This article was originally published in The Gray Sheet
The FDA-endorsed Medical Device Registry Task Force maps out a path toward "coordinated registry networks," starting with pilot projects and 11 prioritized device categories.
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In its 2016-2017 strategic priorities, the device center lays out specific goals for putting more emphasis on real-world postmarket data to support regulatory decisions, making better use of patient-preference input, and enhancing quality at CDRH and in industry. Topping FDA's list: gaining access to 25 million electronic patient records with device identification from global registries, insurance claims data and electronic health records, and expanding that number to 100 million by the end of 2017 to support premarket and postmarket decisions.
The appointments of three device industry veterans to the Brookings-administered, and partially FDA-funded, Planning Board is intended to expand the range of input in the next phase of development of a new National Medical Device Surveillance System.
The public-private National Medical Device Evaluation System Planning Board, first convened in 2014, is seeking nominations for new members to support the next two-year phase of development of a revamped postmarket surveillance system.