A study published in The BMJ has revealed that nearly one-third of medical device manufacturers' adverse event reports are submitted late to the FDA. The analysis found that 54.8% of these late reports came from just 3 manufacturers and 13 medical devices, indicating that reporting delays are concentrated within certain companies and products. These findings raise serious concerns about compliance, patient safety and regulatory oversight within the medical device industry.

These findings emphasize the importance of timely post-market surveillance for companies involved in the development and distribution of medical devices. Delayed reporting can hinder regulatory action, weaken public trust and leave companies vulnerable to legal and financial risks. Compliance with reporting regulations is needed for both regulatory approval and maintaining industry credibility.