FDA’s Sentinel Initiative Will Not Burden Industry

The FDA’s launch of Sentinel, an initiative designed to transform the agency’s postmarket surveillance system through public and private partnerships, 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 CDRH’s 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.”

HHS announced Sentinel’s launch last week in anticipation of the Centers for Medicare & Medicaid Services (CMS) publishing a final rule giving the FDA and other state and federal agencies access to Medicare Part D claims data. The rule takes effect June 27, CMS said.

CDRH already is using CMS data although not specifically related to Sentinel’s initial launch. “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.

The FDA’s Sentinel report can be accessed at www.fda.gov/oc/initiatives/advance/reports/report0508.pdf. The CMS final rule is available at www.cms.hhs.gov/PrescriptionDrugCovGenIn/Downloads/PartDDataReg.pdf.