FDA Report outlines plan to implement med device surveillance system - February 23, 2015, By Susan D. Hall, FierceHealthIT
The FDA’s vision for medical device postmarket surveillance calls for “a national system that quickly identifies poorly performing devices, accurately characterizes and disseminates risk and benefit information about real-world device performance, and efficiently generates data to help support premarket clearance or approval of new devices and new uses of currently marketed devices,” according to a blog post coauthored by Jeffrey Shuren, Director of FDA’s Center for Devices and Radiological Health, and Thomas Gross, Director of the Office of Surveillance and Biometrics at CDRH
G2X TAKE: This is very much in the planning stages, but it is hard to not look at any program when they are talking about this kind of funding. It will not be a stand-alone system, but build upon and coordinate with existing programs, support Congress’ mandate to include medical devices into the Sentinel Initiative, as well as coordinate with PCORI on its efforts to build a national research network. While I am certain some of the bigger players at FDA and those with deep commercial experience, such as Booz Allen and IMS Health, will be looking to position, this program is just as likely to end up with an outside independent research organization. See the Sentintel and Mini-Sentinel award to Harvard Pilgram as prime examples.