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Reliable postmarket information is often lacking about the safety and effectiveness of medical products approved by the US Food and Drug Administration (FDA). Electronic health data can help provide such information. For example, the FDA's Sentinel Initiative is a national electronic system for using health insurance claims data to monitor the postmarket safety of prescription drugs, and the Vaccine Safety Datalink—a collaborative project between the Centers for Disease Control and Prevention and a number of health care organizations—integrates multiple electronic data sources to evaluate the safety of vaccines. There are no similar programs, however, for postmarket surveillance of medical devices.
Rising J, Moscovitch B. The Food and Drug Administration's Unique Device Identification SystemBetter Postmarket Data on the Safety and Effectiveness of Medical Devices. JAMA Intern Med. 2014;174(11):1719-1720. doi:10.1001/jamainternmed.2014.4195