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An Assessment of the U.S. Food and Drug Administration's Postmarket Surveillance of Medical Devices

As the information that the U.S. Food and Drug Administration (FDA) receives about medical device safety and effectiveness is increasingly gathered in the postmarket setting, it is more important than ever that FDA's postmarket safety surveillance system can effectively identify and act on safety signals. We will assess and describe how FDA's established passive postmarket surveillance system identifies and tracks safety concerns, and assess FDA's response to those concerns. We will also describe how elements of FDA's newer surveillance system initiatives, such as the Unique Device Identification system, are being integrated into the passive postmarket surveillance system. In addition, we will describe how FDA plans to integrate these initiatives into the National Evaluation System for health Technology, its in-development active postmarket surveillance system.

Announced or Revised Agency Title Component Report Number(s) Expected Issue Date (FY)
October 2019 Food and Drug Administration An Assessment of the U.S. Food and Drug Administration's Postmarket Surveillance of Medical Devices Office of Evaluation and Inspections OEI-01-19-00470 2020