It is interesting to learn that Section 522 of the Federal Food, Drug and Cosmetic Act gives the FDA the authority to require a manufacturer to conduct post-market surveillance of a class II or class III device when the device meets the following criteria:
(1)its failure would be reasonably likely to have serious adverse health consequences;
(2)it is expected to have significant use in pediatric populations;
(3)it is intended to be implanted in the body for more than one year; or
(4)it is intended to be a life-sustaining or life-supporting device used outside a device user facility.

There are many ways in which the FDA uses and request a post market surveillance. Some of the current medical device post-market surveillance system used are:
1. Medical Device Reporting (MDR) – In which the CDRH requires a mandatory MDR from device manufacturers, user facilities and importers. Therefore, manufacturers, user facilities and importers must report under the MDR
regulations whenever they become aware of an event that reasonably suggests that a device may have caused or contributed to a death or serious injury. In addition, malfunctions must be reported too and failure to comply with the MDR could render the device “misbranded,” and may result more severe penalties such as injunction, seizure or civil money penalties. In addition, health professionals and consumers could also voluntarily report to the FDA adverse events relating to the use of marketed medical devices.

2) Medical Product Safety Network (MedSun) — MedSun is an enhanced
surveillance network comprised of approximately 280 hospitals nationwide
that work interactively with the FDA to better understand and report on medical device use and adverse outcomes in the real world clinical environment.

This link gives more current FDA medical device post-market surveillance strategies. http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM301924.pdf