FDA Failed to Adequately Test Medical Devices before Approval

Most patients assume that a medical device goes through the same sort of premarket approval (PMA) scrutiny, such as clinical trials, to gain approval by the U.S. Food and Drug Administration (FDA) before the device is marketed. That assumption would be wrong.

The Wall Street Journal reports on a published study in the medical journal Archives of Internal Medicine that shows many hazardous medical devices that have caused injury and death did not go through adequate testing on patients prior to approval. It’s hard to believe, but the little known way to fast track a medical device to the marketplace is known within the FDA as 510(k). As long as a manufacturer claims in a paperwork application that its new medical device is “substantially equivalent” to a device that is already on the market, there is no requirement for the expensive and time-consuming PMA testing.

A 510(k) medical device approval can cost about $20,000 per application compared to (PMA) testing, which takes years and costs more in the area of $800,000.

The 510(k) process does not just apply to tongue depressors or blood pressure cuffs, which carry a low or moderate risk, but implantable devices have been approved under 510(k), such as defibrillators and synthetic surgical mesh for incontinence and hernias.

The FDA has known about the problem with 510(k) testing for some time but has failed to tighten the loophole, according to the study. Author Diana Zuckerman said that reform of the regulatory process is needed now.

The Florida defective medical device attorneys at Farah & Farah would like consumers to become knowledgeable about a medical device before it’s implanted in their body. Ask the doctor if the device was approved under 510(K) and if the doctor doesn’t know the answer, the consumer should check the FDA’s database. Put in the name of the manufacturer in the applicant space, or check with the manufacturer. And if you have a problem with a medical device, report it to MedWatch.

This knowledge could mean the difference between life and death. The article states that 113 medical devices that were recalled between 2005 and 2009 were approved for the market through the 510(k) process instead of PMA.