Although most manufacturer reports of medical device adverse events are reported on time, a considerable proportion are submitted late, according to a study published online March 12 in the BMJ.

More than 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) within the deadline set by federal regulations, finds an analysis of recent ...

The Government Accountability Office issued a report at the end of July showing that the number of adverse events reported to FDA for medical devices increased to 588,161 in 2008 from 189,450 in 2004.

No, it wasn't your imagination - the UK's medical device sector really did have an abnormally high number of significant problems last year. That's one of the conclusions of the UK's Medicines and ...

NEW DELHI: The National Medical Commission (NMC) has directed all medical institutions to set up a committee to monitor adverse events related to medical devices, with the aim of monitoring, assessing ...

As a way to improve the accuracy and capture of medical device adverse events, the International Medical Device Regulators Forum (IMDRF), a voluntary and global group of device regulators, on Monday ...

In 2022, nearly 900 medical devices were recalled by FDA, representing a 125% increase compared to 2012, which saw 399 recalls. That number included 70 Class I recalls — FDA’s highest and most serious ...

New Delhi: The health ministry is establishing an expert committee to monitor medical devices for adverse effects and to take ...

Living with diabetes, Carlton "PeeWee" Gautney Jr. relied on a digital device about the size of a deck of playing cards to pump insulin into his bloodstream. The pump, manufactured by device maker ...

Over 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) within the deadline set by federal regulations, finds an analysis of recent data ...