The article by Zuckerman et al1 reported that 80 (71%) of the 113 high-risk medical devices recalled by the US Food and Drug Administration (FDA) between 2005 and 2009 were originally approved via the 510(k) process (§510[k] of the Food, Drug, and Cosmetic Act) rather than the more stringent premarket approval (PMA) application process and concluded that more stringent regulation is required.1 However, when they evaluated the frequency with which approved devices were recalled, the authors failed to calculate the most appropriate measure, namely the probability that a device approved via either pathway would subsequently be subject to a high-risk recall. Specifically, the authors calculated the proportion of recalled devices that were approved via each pathway rather than calculating the proportion of devices approved via each pathway that were recalled. We provide the pertinent calculation herein.
Connor JT, Lewis RJ, Berry DA, Berry SM. FDA Recalls Not as Alarming as They Seem. Arch Intern Med. 2011;171(11):1044-1046. doi:10.1001/archinternmed.2011.242