BMJ Study Finds Gaps and Delays in Bulk Device Adverse Event Reports to FDA

Bulk summary reports that medical device manufacturers submit to the US Food and Drug Administration often fail to flag potential safety signals promptly, according to a cross-sectional study published in The BMJ on October 14, as described in the journal publisher's press release.

US regulations require device makers to report malfunctions and adverse events to the FDA's Manufacturer and User Facility Device Experience (MAUDE) database within 30 days. The reports feed into postmarket surveillance and can inform actions such as recalls.

What the researchers found

The researchers analysed every adverse event summary report submitted to MAUDE over six years, from July 2019 to June 2025. They looked for incomplete identification of device problems, undercounting of events, reports not correctly labelled as summaries, and delays in reporting serious events.

The FDA received 6,308 summary reports in that period, containing 159,503 adverse events and mostly involving high-risk devices, the release said. Of those reports:

• 57% identified no device or use problem.
• 38% reported insufficient information.
• 11% were incorrectly identified as non-summary reports.
• 7% incorrectly listed a single event in the "number of events" field.
• 55% exceeded the FDA's 30-day reporting deadline.

The number of summary reports submitted to the FDA, and the number of adverse events within them, more than doubled between 2020 and 2024, according to the researchers.

"Immediate improvements are needed to better protect patient safety and adhere to transparency principles outlined by the FDA," the authors wrote. "Making serious adverse event reports fully visible and accessible is critical to patient safety."

The authors acknowledged the limits of passive adverse event reporting and the lack of publicly available information on the specific requirements that govern summary reporting exemptions, the release said. The study was externally peer reviewed and funded by the University of California, San Francisco School of Medicine.

Summary reporting and the FDA

Earlier programs, notably the Alternative Summary Reporting program, allowed manufacturers to submit millions of adverse events as bulk summaries rather than individual reports. The FDA ended that program in 2019 over concerns that it masked safety signals, but similar exemptions remain in use, according to The BMJ's release.

One current route is the FDA's Voluntary Malfunction Summary Reporting program, which the agency says began in 2018 and allows manufacturers to report certain device malfunctions in summary form each quarter. The FDA describes transparency to the agency and the public as a key principle of the program "regardless of whether the information is reported as an individual MDR or VMSR." The BMJ's release does not break down the study's findings by exemption type.

Editorial calls for registry links

In a linked editorial, Koji Todaka of Kyushu University Hospital in Japan said the findings raise concerns about transparency in a system meant to support public scrutiny of device safety, according to the release. He called on regulators to require accurate and timely summary reporting, standardised device identification and clear links to registries.

Todaka also noted that the FDA is moving to a new Adverse Event Monitoring System designed to consolidate existing reporting systems and publish adverse event reports in real time. "Transparency builds trust, evidence improves safety, and both are essential to effective postmarket surveillance and safer medical devices," he wrote.