FDA Doubles Down on Active Surveillance, Real-World Data

Posted November 27, 2018

The Food and Drug Administration (FDA) has committed to developing a world-class system for identifying and reacting to device safety issues that leverages active surveillance and big data.

The goal, according to a statement by FDA Commissioner Scott Gottlieb and FDA Center for Devices and Radiological Health (CDRH) Director Jeff Shuren, is to ensure that “the FDA is consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices.”

To reach these heights, the FDA will expand its investment in the National Evaluation System for health Technology (NEST) to allow a “more rapid build-out” of the system to help the FDA collect and analyze the real-world evidence it needs to identify, communicate, and act on medical device safety concerns.

“We’re evolving beyond our current postmarket surveillance system—which is largely passive and relies on device users to report problems to us, sometimes resulting in underreporting. We’re moving to an active surveillance system that relies on real-world evidence and timely receipt of robust safety information,” Gottlieb and Shuren said.

Delivering on the FDA’s ambitious goal rests on the ability to “fully leverage NEST as an active surveillance and evaluation system that complements the approaches currently in use by more quickly detecting emerging safety signals through active surveillance, supporting timely evaluation of these signals to determine if they represent a real risk to patients, and ensuring timely responses to new and increased risks,” the FDA wrote.

The biggest roadblock is funding, according to the FDA. The agency is doing “whatever possible to build out NEST now,” according to Gottlieb and Shuren, including allocating an additional $3 million in agency funding to NESTcc (an independently-run public-private coordinating center) in September. “However, for NEST to become fully functional and fulfill its promise of helping to ensure safer devices for patients, additional resources are essential,” they said.

To that end, President Donald Trump’s administration has requested $46 million in additional funding to support NEST and other FDA-sponsored postmarket studies in its 2019 fiscal year budget.

With the FDA’s support, NESTcc recently began test case demonstration projects to study the effectiveness of medical device postmarket surveillance activities using used real-world data and NEST. The FDA also is working to link real-world data sources through its Coordinated Registry Networks, which generate clinical evidence about medical products used by patients.

“The promise of NEST is clear: real-time device safety information means better outcomes for patients who depend on devices to improve their health,” Gottlieb and Shuren said. “We’re committed to making the promise a reality by prioritizing NEST’s development and ensuring it’s set up for long-term success to advance public health.”