Active postmarketing device surveillance as a legislative priority

The US Food and Drug Administration (FDA) requires manufacturers of medical devices, such as ventilators and defibrillators, to report certain adverse safety events, which are then compiled in a centralized database known as the Manufacturer and User Facility Device Experience (MAUDE).1 Manufacturers must disclose safety event details within 30 days, and the FDA relies on these disclosures to decide whether to communicate safety concerns or pursue other regulatory actions. Everhart and colleagues show, in a far-reaching and rigorous analysis of over four million MAUDE database submissions from 2019 to 2022, that manufacturers do not strictly adhere to deadlines when reporting these critical events.2 Approximately 15% of adverse events were submitted after 30 days, and another 15% contained missing or invalid information that precluded a determination of submission timing. Such delays and information gaps can hinder regulatory action, undermine trust in the MAUDE system, and harm patients if problems with sensitive diagnostic equipment (eg, glucose monitors) or life-saving treatments (eg, insulin pumps) are not swiftly addressed.

This study of delayed MAUDE database submissions adds to a growing body of literature on the important limits of passive surveillance, not only for medical …