Medical devices are reviewed by the FDA using two regulatory standards, the premarket approval, which requires clinical testing and inspections, and the 510(k) process, an expedited process which requires the device to be similar to the already marketed device.

For the study, researchers at National Research Center for Women & Families, US, analysed the FDA’s list of high-risk device recalls from 2005 to 2009, and found that 113 such devices were recalled.

Of the total high risk device recalls, 80 (71%) were approved through the 510(k) process, 21 (19%) were approved through the premarket approval process, and eight (7%) were exempt from regulation.

The most common recalled devices were cardiovascular devices (31%) and of these, 66% were approved through the 510(k) process and 12 (34%) were cleared through the postmarket approval process.

The authors note that these findings reveal critical flaws in the current FDA device review system and its implementation that will require either congressional action or major changes in regulatory policy.