The PASSION (Predictable and Sustainable Implementation of National) Registries for Cardiovascular Devices program is building a sustainable national medical device evaluation system for cardiovascular devices which will reduce the burdens and costs of clinical trials and postmarket surveillance, as well as, facilitate the clearance and approval of new devices, or new uses of existing devices.
PASSION involves the development of operational and business models to establish predictable and seamless infrastructure ensuring reliability and cost efficiency of clinical trials conducted through such registry infrastructure. It will provide truly sustainable infrastructure that recognizes that different stakeholders have diverse expectations and value different deliverables from any one medical device registry.
There are two ongoing PASSION pilot projects with specific goals that will result in the development of a framework which will be generalizable to not only other cardiovascular registries, but different clinical areas as well.
PASSION also funds a number of projects as the result of the October 15, 2014 MDEpiNet annual meeting.
If you would like to participate in the PASSION project, contact MDEpiNet_RAPID@dm.duke.edu