An agency director says the FDA's launch of Sentinel, an initiative intended to transform the agency's post-market surveillance system of devices through public and private partnerships, will not further burden device manufacturers. “The program is intended to work with existing surveillance tools, such as post-approval studies and adverse-event reporting systems,” says director of CDRH's Division of Post market Surveillance Thomas Gross.

“We already have requirements for adverse event reporting in place that let manufacturers report device-related deaths, serious injury, and malfunctions. Requirements include post-approval studies for high-risk devices. So we will continue to use those because they are effective tools,” adds Gross. Read the FDA's Sentinel report at www.fda.gov/oc/initiatives/advance/reports/report0508.pdf.