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30% of FDA Medical Device Adverse Events Reported Late – Shocking Delay Statistics!

A recent study reveals that nearly 30% of medical device adverse events were reported to the FDA late. These reports, required to be submitted within 30 days, were often delayed by more than six months after manufacturers were notified. This significant delay in reporting was highlighted in research published in the BMJ. The statistics underscore a critical issue in the timely communication of medical device safety concerns to regulatory bodies.

Source: seekingalpha.com

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Over 1.2 million medical device adverse event reports were not submitted to the US FDA within the deadline set by federal regulations, finds study. More than 400 000 were submitted more than 6 months after the manufacturer was notified of an adverse event

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