According to the reports, 113 medical devices were recalled by the FDA between 2005 and 2009 because they were dangerous. Out of them 81 percent had been cleared under a lenient process reserved for devices deemed "substantially equivalent" to others already approved. This has revealed a critical flaw in the federal review system.

This was the conclusion of the report in Tuesday's Archives of Internal Medicine. They evaluated each of the medical devices. According to the researchers, they have discovered that those recalled cardiac and other devices were approved without clinical trials or higher levels of scrutiny.

"These devices did not undergo clinical testing or premarket inspections, nor were post market studies required to determine safety and efficacy", wrote Diana Zuckerman of the National Centre for Women & Families.

In addition to this the researchers also discovered that around 12 percent of the recalled devices that were approved under the 510(k) process were originally marketed for "risky or life-sustaining Class III indications, which are required by law to undergo a full PMA regulatory review."

However, FDA did not comment on this issue. The research statistics show that the average cost for the FDA to review a 510(k) submission was estimated at $18,200, and a PMA submission cost the agency $870,000 for review.