FDA's MDEpiNet - Improving Medical Device Safety and Effectiveness

Danica Marinac-Dabic, MD, PhD (Director, Division of Epidemiology, FDA Center for Devices and Radiologic Health) describes the Medical Device Epidemiology Network (MDEpiNet), FDA's innovative initiative to advance the methodologies of studying medical devices by building a collaborative network with academic institutions.

MDEpiNet will:

· drive the effective synthesis of data about the performance of a given medical device from a broad array of sources

· increase comparative effectiveness research to evaluate and directly compare multiple treatment options

· advance analytic methods used in medical device research

· create a forum for the exchange of ideas among stakeholders within the medical device community

· provide vital external expertise for FDA communications with the clinical community and the public at large

Through the partnership created between FDA and academic researchers, MDEpiNet will result in better information about medical devices and better decision-making by FDA, the device industry, medical professionals and patients. [vpmedicaldevices]