Enhancing post-market surveillance through developing registries for medical device epidemiology (U01)

(1) To address identified gaps in the current postmarket surveillance system by developing new methodologies for registry data collection and linkage, or by adapting known methodologies to medical devices, and (2) To develop novel methodology that allows for use of the registry data collection infrastructure to serve multiple purposes including postmarket surveillance, device tracking through Unique Device Identifiers (UDI), prospective embedded studies, quality improvement, and other uses, and(3) To develop registries and consortia in key medical device areas to implement new registry methodologies that strategically broaden the scope of the US and international postmarket surveillance system.