FDA Blames Over-Reporting For Record-High Recall Count In 2013; Looks To Root Causes
• By Shawn M. Schmitt
The number of medical device recalls initiated by manufacturers last year hit an all-time high, according to an analysis by “The Silver Sheet.” FDA says the increase resulted in part from over-reporting of recalls by wary firms that were dinged in the past by the agency for not reporting. “Once a firm has been cited by an investigator, it is a wonderful reporter of recalls after that,” FDA official Ann Ferriter said in an interview. “They report a disproportionate number of recalls.” Meanwhile, the agency looks to root causes for answers. Failing to conduct thorough root cause investigations “sends a message to the FDA that maybe you do not have control over your recall,” CDRH Recall Branch Chief Ron Brown says.
The medical device industry chalked up the most product recalls ever in calendar year 2013, including an historic number of high-risk class I’s – a potentially costly state of affairs for manufacturers that could also shake customer loyalty.
But FDA claims the increase is due to manufacturer over-reporting and sensitivity to media reports about problem products, and not...
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