Earlier this year, the U.S. FDA released its Medical Device Safety Action Plan, which outlined actions to enhance medical device safety and efficacy. Following public feedback, the agency is announcing a series of updates to enhance nationwide post-market surveillance, improve post-market safety, and encourage innovations that lead to safer medical devices.
In a statement, FDA Commissioner Scott Gottlieb, MD, and Jeff Shuren, MD, director of the Center for Devices and Radiological Health remarked: “We’re evolving beyond our current post-market 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.”
“We have long recognized the systemic weaknesses of the passive system—a challenge faced by other countries—and we prioritized this area for regulatory reform efforts,” Gottlieb and Shuren add.
Moreover, the FDA’s announcement focuses on key actions to create a more robust medical device safety net for patients through better data with particular attention on devices for women’s health. Specifically, the FDA has allocated an additional $3 million in agency funding to support its national independently-run public-private coordinating center for gathering real-time evidence on medical device safety to support pre- and post-market decision-making.
Part of this funding will support National Evaluation System for Health Technology demonstration projects while another portion will go toward the Women’s Health Technologies Coordinated Registry Networks, which links various real-world data sources to address clinical questions on device therapies that are unique to women.
Next week, the FDA will announce additional actions aimed at fundamentally modernizing the process for medical device review, particularly as it relates to the 510(k) process.