More than 1.2 million medical device adverse event reports, constituting nearly one-third of all submissions, were not promptly reported to the U.S. Food and Drug Administration (FDA) as required, according to a recent report. Researchers assessed the timeliness of adverse event reporting by medical device manufacturers, highlighting the significant delays and the potential impact on postmarket surveillance. The results indicated that a considerable number of reports were submitted late, with stricter compliance measures and greater transparency suggested as potential improvements.
Study Shows Widespread Delays in Medical Device Reporting to FDA
Conexiant
March 19, 2025