About One Third of Medical Device Adverse Events Were Submitted Past Regulatory Deadline, Study Says

A new study published in BMJ found that nearly a third of manufacturer reports of medical device adverse events were “not demonstrably submitted to the FDA within the regulatory deadline.”

The majority of medical devices “receive regulatory authorization based on non-clinical data or clinical trials with limitations in their design,” making postmarket device safety surveillance even more important. The central tool for postmarket surveillance is “the FDA’s Manufacturer And User Facility Device Experience (MAUDE) database, where manufacturers and other stakeholders report device related adverse events and product problems (hereafter adverse events). MAUDE reports are the most common source of information used to initiate medical device safety communications, the FDA’s primary mechanism for communicating postmarket device safety issues.”

MAUDE has limitations; reports have recently indicated that manufacturers have withheld reports from MAUDE years beyond their deadline to submit them. This study aimed to quantify the timeliness of such reports in the MAUDE database.

The researchers analyzed over 4,000,000 medical device adverse event reports submitted by manufacturers to the MAUDE database between September 1, 2019 and December 31, 2022. Over 1,000,000 of those reports “were not demonstrably reported within the timeframe allowed by the FDA. Over 400,000 reports were reported more than six months (180 days) after manufacturer notification of the event, representing more than two thirds of all late reports.” These late reports are possibly attributable both to previously reported knowing withholding of important safety information by manufacturers, but they are also possibly caused by “the time required for manufacturers to verify adverse events and gather additional information before reporting events to the FDA. Nonetheless, late reporting is not permitted under existing regulations, regardless of intent.” Additionally, more than 50% of late reports “were attributable to three manufacturers.”