According to a recent report by FDA's Center for Devices and Radiological Health ("CDRH"), the annual number of medical device recalls increased by 97 percent from fiscal year 2003 to fiscal year 2012. The report attributes this increase to enhanced awareness by device manufacturers and specific efforts by FDA to improve medical device safety. Most recalls relate to device design, software, and nonconforming material or component issues. The report says joint action by device manufacturers and CDRH to address these issues could prevent as many as 400 recalls each year. Still, CDRH notes that the significant increase in recalls is not necessarily a sign of declining quality because many recalls are the result of companies exercising more caution after being cited for recall violations in the past.
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