Improving FDA postmarket adverse event reporting for medical devices

Abstract:

Postmarket surveillance represents a critical component of the US Food and Drug Administration’s (FDA) lifecycle assessment of medical devices, as many devices—including high-risk implanted devices—are often approved on the basis of limited premarket clinical efficacy and safety data. 1 The FDA collects information on realworld adverse events through passive surveillance and shares it with the public using the agency’s Manufacturer and User Facility Device Experience (MAUDE) database, a national database of deviceassociated deaths, injuries and malfunctions. Reporting to the FDA is mandatory for certain entities, including manufacturers and healthcare facilities, and voluntary for others, such as physicians and patients. This system is similar to the one in place under the European Union Medical Device Regulation, except that only manufacturers are required to report, and other stakeholders, including …