HHS to Report on Postmarket Surveillance in 2020
HHS’ Office of Inspector General (OIG) plans to release a report on the FDA’s medical device postmarket surveillance system next year.
The report will evaluate how the passive postmarket surveillance system pinpoints and assesses safety concerns and analyze how the agency responds to them.
It will also cover newer elements, including the Unique Device Identification system and how UDIs are used in postmarket surveillance.
“It is more important than ever that FDA's postmarket safety surveillance system can effectively identify and act on safety signals,” the OIG said.