Postmarket Surveillance of Medical Devices
A Comparison of Strategies in the US, EU, Japan, and China
In a study published in PLOS Medicine and supported by Pew’s medical device initiative, researchers evaluated strategies for postmarket surveillance of medical devices in the United States, European Union, Japan, and China. Findings showed that each postmarket surveillance system shares many common elements, including reliance on passive adverse event collection for marketed devices, but vary widely with regard to evaluating the performance and safety of devices.
The research concludes that postmarket surveillance may be improved through greater transparency and scheduled reexamination of approved devices, among other ideas.
Read the full study