FDA Failed to Properly Test Medical Devices before Approval

By Blume Forte Fried Zerres & Molinari on March 9, 2011

CNN recently reported that a review of recall data from the U.S. Food and Drug Administration (FDA) found that the majority of the 113 Class III medical devices that were recalled between 2005 and 2009 for serious, life-threatening dangers, did not undergo the FDA’s more rigorous pre-market approval process, also referred to as “PMA.” Instead, the agency cleared the devices using a less stringent process known as the 510(k) process, under which clinical testing is not required. This discovery brings to light that many medical products that were given clearance, such as automated external defibrillators (AEDs), artificial hip joints, and heart valves, were marketed to and used on consumers without undergoing clinical testing in advance.

Under FDA policy, all Class III devices are required to undergo the PMA premarket approval process, including clinical testing, in order to determine if “sufficient valid scientific evidence” is found that the medical device is safe for its intended use.

However, a report from the Government Accountability Office in 2009 discovered that approximately 66 percent of all Class III devices were approved using the less demanding 510(k) process instead of the PMA because it was “less burdensome”. An additional study, published in the Journal of the American Medical Association’s Archives of Internal Medicine, found that approximately 71 percent of the 113 medical devices recalled between 2005 and 2009 were given approval through the 510(k) process.

Many believe the reasons for the shortcomings in testing are because the agency does not have the necessary funding and staff to conduct a clinical study for all medical devices requiring same. While a medical device’s manufacturer does pay for a fraction of the expenses related to a PMA approval, the majority of the cost falls to the FDA, which is under-funded. Choosing to approve a medical device under the 510(k) process is much less expensive.

The FDA has admitted that the 510(k) approval process needs to be toughened, and has stated it intends to take action to improve the process in 2011. Additionally, the FDA has stated it will evaluate all remaining Class III devices slated for the 510(k) process to determine if the device should undergo the PMA process. As a result, there may be dangerous medical devices on the market that have not received proper government approval.

If you believe that a defectively designed or manufactured medical device may have seriously affected your health or the health of a loved one, contact a New Jersey product liability attorney at Blume Forte. Call 973-635-5400 to schedule a no-cost consultation with one of our lawyers.

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