Connor et al conclude that the large percentage of high-risk recalled devices that have been cleared through the FDA's less stringent 510(k) process is acceptable because only 113 of thousands of types of devices were recalled. Their analysis does not take into account the impact of dangerous medical devices on the health of patients or the costs of health care. It also does not consider the importance of federal agencies following the law consistently in their regulation of medical products.
Zuckerman DM, Brown P, Nissen SE. FDA Recalls Not as Alarming as They Seem—Reply. Arch Intern Med. 2011;171(11):1044–1046. doi:10.1001/archinternmed.2011.243
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