FDA’s Approach to Medical Device Approval Criticized

A group of US researchers have criticized the workings of the Food and Drug Administration after stating that nearly three fourths of the medical devices withdrawn from the market due to health risks were approved by the FDA without testing them on humans. Researchers from National Research Center for Women & Families and Cleveland Clinic found that 113 medical devices were recalled during 2005 to 2009. The researchers found that over 80 percent of the devices underwent approval with just a cursory testing with many being wrongly compared to similar devices already in the market.

More than 30 percent of the devices dealt with heart disease and automatic external defibrillators (AEDs). AEDs are used to give shocks to people who suffer from sudden cardiac arrests. However with many of the new AEDs being faulty, the researchers said that such devices have led to hundreds of patient deaths.

“Our 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”, lead researcher Diana M. Zuckerman wrote in the study which has been published in the Archives of Internal Medicine.


Source-Medindia