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FDA Blames Over-Reporting For Record-High Recall Count In 2013

This article was originally published in The Gray Sheet

Executive Summary

The number of medical device recalls initiated by manufacturers last year hit an all-time high, likely caused in part by over-reporting of recalls by wary firms that were dinged in the past by FDA for not reporting. “Once a firm has been cited by an investigator, it is a wonderful reporter of recalls after that,” an agency official says.

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