
Nearly three-quarters of Class I medical device recalls went through the Food & Drug Administration’s 510(k) pre-market notification process from 2005 to 2009, according to a report in the Archives of Internal Medicine.
That’s proof that high-risk devices should not be cleared for market using the quicker and less stringent 510(k) process, the authors claim, arguing that the devices should instead be reviewed via the more rigorous — and costly — pre-market approval program. Class I recalls, the most serious level, are issued for devices that could cause serious injury or death.