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A pair of top officials at the FDA are advocating for a national oversight system for medical devices that would combine pre- and post-market clinical studies with adverse event reporting and electronic health records.
FDA commissioner Dr. Robert Califf and Dr. Jeffrey Shuren, head of the agency’s Center for Devices & Radiological Health, wrote in the Journal of the American Medical Assn. that their vision would incorporate “ecosystem stakeholders such as patients, health care professionals, health care organizations, payers, the medical device and digital health industries, and the government.”
Their system would be built on the National Evaluation System for Health Technology the FDA launched in 2012, taking “a strategic approach to linking and using clinically based data sources, such as registries, electronic health records (EHRs), and claims data” that “could potentially reduce the burdens of obtaining appropriate evidence across the life cycle of a device.”
