FDA’s Sentinel Initiative Will Not Burden Industry
The FDA’s launch of Sentinel, an initiative designed to transform the agency’s postmarket surveillance, will likely not place additional regulatory burdens on devicemakers, according to an agency director.
“There won’t be more requirements because of the Sentinel effort,” Thomas Gross, director of the FDA’s Center for Devices and Radiological Health (CDRH) Division of Postmarket Surveillance, said. The program is designed to complement existing surveillance tools, such as postapproval studies and adverse event reporting systems.
“We have requirements in place already,” Gross said, such as “adverse event reporting, where manufacturers are required to report device-related deaths, serious injury and malfunctions. We have requirements for so-called postapproval studies for high-risk devices. So we will continue to use those because they are very effective tools. … That won’t change.”
In the first stage of the initiative, the FDA will have access to the Centers for Medicare & Medicaid Services’ database of Medicare Part D prescription drug claims. “We’ve done some pilot work in exploring the use of Medicare data, and we’d like to pursue that in the future … because it can be applicable to device safety issues,” Gross said.
CDRH said once Sentinel is up and running, the FDA will be able to query specific adverse event data in large databases containing claims or electronic health information maintained by private and federal organizations that agree to participate in the program.
However, “this capability will not be fully realized until unique device identifiers are established and incorporated into these databases,” CDRH said.