Author Affiliations: National Research Center for Women & Families, Washington, DC.
Fogarty draws the same erroneous conclusion as Connor et al,1 saying that the reason why the number of high-risk recalls are primarily from devices cleared through the 510(k) process rather than the more rigorous PMA process is because most devices go through the 510(k) process. However, the problem is not the number of recalls, it is the number of high-risk recalls of devices that the FDA concludes could cause death or serious permanent harm. Current law requires the FDA to use their more rigorous PMA review if a medical device is life sustaining or otherwise high risk.2 And yet, our study found that most recalls of potentially deadly devices were for devices that had been cleared through the 510(k) process as low or moderate risk.3 Most of these high-risk recalls are caused by predictable problems, such as implants that break or diagnostic tests that are inaccurate. The more rigorous PMA process would have been more likely to identify risks in a clinical trial, inspection of the manufacturing facility, or required postmarket study. All those safeguards are absent in the 510(k) process.
Zuckerman DM, Brown P, Nissen SE. More on Device Recalls—Reply. Arch Intern Med. 2011;171(21):1959-1964. doi:10.1001/archinternmed.2011.563