IOM Report Released: IOM calls FDA approvals for medical devices "fatally flawed"

The Institute of Medicine (IOM), an advisory group for the Food and Drug Administration (FDA), issued a report proposing that the 510(k) accelerated approval program for medical devices be replaced. Reporting that the current system does not sufficiently protect patients, IOM suggested that the FDA use a more thorough process for testing the safety of medical devices prior to approval despite the potential for increased costs to device manufacturers.

As quoted in a report by Reuters, Chairman of IOM's Committee Dr. David Challoner said, "What we are recommending is that the 510(k) is fatally flawed in terms of not evaluating safety and effectiveness of a device."

The FDA, however, rejected IOM's findings and said it is open to improvement proposals but that the 510(k) accelerated approval should not be eliminated as it allows medical devices to reach the consumers more quickly.

"We see firsthand the backlash these recalled devices have on people. It seems to me the public needs to have a bigger voice on issues that involve the safety of our parents, our children and our friends. Currently, that voice is being drowned out by manufacturers' financial clout," said Motley Rice member and medical device lawyer Fred Thompson.

Recent medical device recalls from products approved in the 510(k) process include the 93,000 artificial hip implants manufactured by Depuy® Orthopaedics, a division of Johnson & Johnson. Motley Rice attorneys are currently litigating cases on behalf of victims of recalled medical devices that were initially approved using the 510(k) review process, including:

Read Reuters's full article on the 510(k) approval debate.

Learn more about how Motley Rice device lawyers are fighting on behalf of patients who may have suffered injuries or complications related to defective medical devices.