FDA Commissioner: US needs improved system to track medical device issues

The U.S. needs a stronger national evaluation system to efficiently detect and address medical device issues, said Robert Califf, MD, Food and Drug Administration Commissioner, and Jeffrey Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health, in an op-ed published in JAMA.

Drs, Califf and Shuren believe better postmarket surveillance of medical devices stems from harnessing information from device registries, EHRs and claims data.

The FDA's Sentinel Initiative collects claims data on the clinical outcomes of more than 100 million individuals. Drs. Califf and Shuren call for unique device identifiers to be incorporated into this database to help monitor long-term outcomes of medical devices.

The call to improve the national evaluation system for health technology falls in line with the FDA's goal to better identify problematic devices, release data on device performance in clinical practice, and efficiently create data to support premarket clearance or approval of new devices or indications.

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