A new study published in The BMJ has uncovered significant delays in medical device manufacturers reporting adverse events to the Food and Drug Administration (FDA).
The study analyzed 4.4 million manufacturer reports from 2019 to 2022 and found that nearly 14% (600,000 reports) were submitted late, while another 600,000 had missing or invalid dates. Most concerning, 1,004 death reports were among those filed past the 30-day regulatory deadline.
Under FDA regulations, manufacturers must report serious safety incidents, including injuries, device malfunctions, and deaths, within 30 days of becoming aware of them.
However, the study revealed that late reports were often submitted in batches, raising concerns that manufacturers may be intentionally delaying the release of crucial safety data. While verifying incidents takes time, researchers suggest that delayed reports hinder timely interventions that could protect patients.
The Potential Risks of Delayed Reporting
- Delayed Recalls – When manufacturers fail to report issues promptly, faulty medical devices remain on the market longer, increasing the risk of patient harm.
- Lack of Transparency – Late or missing reports make it harder for doctors and patients to make informed decisions about device safety.
- Weakened FDA Oversight – The FDA relies on timely reporting to monitor device performance and issue safety alerts, but inconsistent data can compromise regulatory actions.
This study underscores the urgent need for stricter reporting enforcement to prevent future safety lapses.
