HHS Inspector General to Analyze Postmarket Surveillance in 2020

HHS’ Office of Inspector General (OIG) announced plans to release a report on medical device postmarket surveillance system next year.

The 2020 report will evaluate the methods the FDA uses in its passive postmarket surveillance system to identify safety concerns and will analyze how the agency responds to them.

“As the information that the 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,” OIG said.