The FDA has called for stricter regulations against unsafe products approved by the 510K, substantially equivalent process, in light of thousands of lawsuits filed by patients implanted with metal on metal hip, knee and vaginal mesh devices, as reported by Bloomberg Health News. [Seehttp://www.bloomberg.com/news/2012-02-28/fda-device-chief-says-approval-loophole-needs-closing.html
House Democrats recently introduced legislation allowing the FDA to modify the 510K process most devices are approved under. This modification allows the FDA to reject devices whose designs, manufacturing and testing processes are modeled on previous products that have been recalled because they are unsafe. In other words, a device can be approved as substantially equivalent to an older device which has been recalled [because it was found to be defective]. This calls into question the validity of the safety of the device still on the market. Currently, the FDA does not have that authority in every case.
The Advanced Medical Technology Association, the device industry trade association, argued that the proposed bill would add regulatory burdens for manufacturers who already struggle with lengthy FDA reviews.