FDA officials want a national review system for medical devices

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.”

“By leveraging clinical data and applying advanced analytics and flexible regulatory approaches tailored to the unique data needs and innovation cycles of specific device types, a more comprehensive and accurate framework could be created for assessing the risks and benefits of devices,” Califf and Shuren wrote.

“Recent multistakeholder reports recommended developing a federated virtual system for evidence generation by creating strategic alliances among data sources including registries, EHRs, payer claims, and other sources; incorporating unique device identifiers (UDIs) over time; and activating multiple linkages among data sources to address specific questions,” they wrote. “NEST should be operated by an independent coordinating center with governance comprising ecosystem stakeholders such as patients, health care professionals, health care organizations, payers, the medical device and digital health industries, and the government. Essentially, NEST should be of, by, and for the medical device ecosystem and configured to provide maximal value to stakeholders, including the critical data needed by the FDA to make decisions that currently must be made with less comprehensive information.”

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