[United States Medical Device Postmarket Surveillance System Operational Experience and Learning].

To learn the progress, structure and the latest development of medical device postmarket surveillance system in United States, endeavor to get a meaningful approach for Chinese medical device manufacturers. Sort out the recentyear guidance documents issued by US FDA, analyze the current situation after the implementation of postmarket surveillance system (PMS). The all-aspect linkage, multiple data sources and the coordination communication mechanism between various departments implemented by FDA are worthy of learning.