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510(k) Approval Process

What’s The FDA’s 510(k) Approval Process and How Does It Hurt Patients?

Most people believe that any medical device available on the market goes through a thorough and effective approval process. The truth is, this is not always the case. The U.S. Food and Drug Administration (FDA) is charged with analyzing new device applications and granting approval to reasonably safe devices; however, the agency has more than one avenue for approval. In addition to the ordinary application process, the FDA has an approval process called 510(k) approval and it’s putting many patients at risk.

What Is The FDA’s 510(k) Approval Process?

The 510(k) approval process is available for medical devices deemed similar to existing devices already been approved by the FDA. At first, this might seem like a good idea. If two devices are similar, why should the FDA waste the time and manpower to review two separate but similar applications? In practice, however, this practice has proven extremely dangerous. The 510(k) approval process does not require the stringent clinical trials that must be submitted during the normal medical device approval process. Once a device is approved via the 510(k) process, it becomes a “predictive” device that future 510(k) submissions can use as the “similar” device for approval.

How The 510(k) Process Is Dangerous

510(k) approved devices enter into the market with very little or no clinical trial data regarding their safety. According to the Institute of Global Health Innovation, 43% of devices approved via the 510(k) process between 2000 and 2004 were approved before clinical trial data regarding the devices’ safety was even published. When clinical trial data is not required for approval, dangerous medical devices are allowed onto the market. A 2011 study published by a health research group found that between 2005 and 2009, 113 medical devices were subject to recall and 80 of those made it to the market through the 510(k) process.

Unfortunately, this hasn’t stopped the FDA from utilizing the 510(k) approval process. According to another study in Journal of The American Medical Association Internal Medicine in 2014, between 2008 and 2012, of 50 new devices cleared by the FDA, only eight were actually “substantially equivalent” to devices already on the market. Additionally, the study also found of all previously cleared devices referenced, only about three percent had support through publicly available evidence.

How This Affects Patients

When devices make it onto the market without medical trial data, patients suffer serious injuries. Medical devices like IVC filters, hernia mesh, and even contraceptive implants like Essure were all approved by the FDA through the 510(k) approval process before being subject to black box warnings and recalls after reports of serious injuries came in from patients. Device manufacturers have no right to put patients at risk. The safety of medical devices shouldn’t be reactive – it should be proactive. However, this doesn’t mean patients are left without recourse. Regardless of how a medical device was approved, all manufacturers are responsible for producing safe products. When they fail to do so, they can be held accountable.

Get Help After Injuries From Defective Medical Devices

If you suffered an injury as a result of a defective medical device, you may pursue compensation through a filing a civil lawsuit. Dax F. Garza, P.C. has successfully represented injured patients against large medical device manufacturers around the country for years. Contact our defective medical device attorneys today for a free consultation to discuss your legal options.

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