* proposing mandatory use of electronic reporting for required adverse event reports and revising the current system that records reported adverse events for devices (the Manufacturer and User Facility Device Experience Database or MAUDE system);
* increasing the use of Medical Product Safety Device Network (MedSun) programsa network comprised of more than 350 hospitals that have been recruited and specifically trained to identify and report device problems, and help provide "real time" data on signals and safety problems;
* enhancing risk/benefit communication efforts so health practitioners, patients and consumers receive clearer and more timely information on public health news; and
* increasing the coordination among the agency's compliance and enforcement programs.


For further information on the initiative, including a copy of the "Postmarket Transformation Leadership Team: Strengthening FDA's Postmarket Program for Medical Devices" report and the January 2006 "Medical Device Postmarket Safety Program Synopsis and Recommendations," visit: www.fda.gov/cdrh/postmarket/mdpi.html.


Back to HCB News

More Industry Headlines