Author Affiliation: Fogarty Institute for Innovation, Portola Valley, California.
I wish to raise my concerns regarding methodological errors and inaccuracies in the article on medical device recalls by Zuckerman et al.1 Relative to the incidences of recalls, one cannot simply compare the gross number of recalls between the 510(k) and premarket approval (PMA) systems because greater than 90% of devices reviewed by the US Food and Drug Administration (FDA) are cleared through the 510(k) system. Rather, one must compare the rates of recall to make a valid comparison between the 2 regulatory clearance processes. In addition, one needs to know the cause of the recall. If the recall was due to a manufacturing issue, the PMA process would not provide additional protection because both PMA and 510(k) devices are subject to the FDA's Quality System Regulations.
Fogarty T. More on Device Recalls. Arch Intern Med. 2011;171(21):1959-1964. doi:10.1001/archinternmed.2011.562