Regulatory Focus™ > News Articles > Five Essential Practices of Compliance

Five Essential Practices of Compliance

Posted 01 July 2011 | By Richard Morroney, CQA, RAC

In October 2000, Guidant Corporation, a manufacturer of cardiac devices, was accused by company employees of covering up devicerelated problems and deaths associated with its Ancure Endograft System. It was found that Guidant had failed to file 2,628 medical device reports with the US Food and Drug Administration (FDA) between 1999 and 2001. In June 2003, Guidant pleaded guilty in federal court to violating FDA medical device reporting (MDR) rules and agreed to pay a fine of $92.4 million. Four days later, the company announced that it was going to stop production of the Ancure Endograft System and shut down its manufacturing subsidiary, Endovascular Technologies.1


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