Study finds FDA medical device adverse event reports often incomplete and delayed

A BMJ study analyzing 6,308 medical device summary reports submitted to the FDA between 2019 and 2025 reveals significant reporting flaws that threaten patient safety. Researchers found that 55% of reports exceeded the mandated 30-day deadline and 57% failed to identify specific device problems. Although the FDA ended its Alternative Summary Reporting program in 2019, summary exemptions persist as report volumes double. The FDA is now transitioning to the Adverse Event Monitoring System to publish safety reports in real time.

BMJ study findings on summary reports

• ▪A study published in The BMJ found that the number of summary reports submitted to the FDA and the adverse events contained within them more than doubled between 2020 and 2024.
• ▪A study published in The BMJ analyzed 6,308 adverse event summary reports submitted to the FDA's MAUDE database from July 2019 to June 2025, which contained 159,503 adverse events mainly involving high-risk devices.
• ▪A BMJ study of FDA MAUDE database summary reports found 57% identified no device or use problem, 38% provided insufficient information, and 11% were incorrectly labeled as nonsummary reports.
• ▪A BMJ study analyzing medical device summary reports in the FDA MAUDE database found that 55% of the 6,308 submitted reports exceeded the mandatory 30-day reporting deadline.

BMJ editorial on device oversight

• ▪In a BMJ editorial, Koji Todaka recommended that researchers integrate spontaneous reports, registries, and linked healthcare data to evaluate medical device safety effectively.
• ▪In a BMJ editorial, Koji Todaka stated that the study findings raise concerns about transparency in a system intended to support public scrutiny of medical device safety.
• ▪In a BMJ editorial, Koji Todaka of Kyushu University Hospital stated that accurate summary reporting and standardized device identification are necessary to maintain public trust in medical device oversight.

Concerns over bulk summary reporting

• ▪Researchers publishing in The BMJ warned that bulk summary reporting of medical device adverse events delays the detection of safety signals, posing significant risks to patient safety.
• ▪The FDA ended its Alternative Summary Reporting program in 2019 due to concerns over masked safety signals, although similar bulk summary reporting exemptions remain in active use.