Industry, FDA Fault Logic Behind 510(k) vs. PMA Recall Study

New devices could be delayed in reaching the market if the FDA embraces recommendations in a recent study on recall rates for devices cleared by 510(k) versus PMA. The study, published in the Feb. 14 Archives of Internal Medicine, claims devices cleared through the 510(k) pathway make up more than two-thirds of Class I recalls, the most severe types of recalls that indicate a potential for serious injury or death. Eighty of the 113 medical devices recalled between 2005 and 2009 were 510(k)-cleared, compared with 21 PMA devices.
Devices & Diagnostics Letter