FDA’s New Active Monitoring for Medical Device Safety

The FDA’s new active monitoring system aims to enhance medical device safety by using real-world evidence from electronic health records. However, its slow implementation and existing challenges raise concerns about effectiveness in catching issues, especially given insufficient pre-market testing standards.

November 19, 2024

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1–2 minutes

Sources and References

“FDA’s MAUDE Database for Medical Device Reporting.” U.S. Food and Drug Administration, http://www.fda.gov/medical-devices/medical-device-reporting-mdr/how-make-medical-device-report.

Jaklevic, Mary Chris. “FDA to Launch ‘Active’ Monitoring System to Improve Medical Device Safety.” Association of Health Care Journalists, 18 Sept. 2024, https://healthjournalism.org.

Lenzer, Jeanne. The Danger Within Us: America’s Untested, Unregulated Medical Device Industry and One Man’s Battle to Survive It. Crown, 2017.

Zuckerman, Diana. “Medical Device Safety: Challenges and Opportunities.” National Center for Health Research, http://www.center4research.org/medical-device-safety.

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