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Defective Medical Device Issues: 510K Clearance vs. PMA Approval


Implantable medical devices offer invaluable benefits to individuals suffering from a broad range of ailments. They help people breathe, they help people walk and they provide an enhanced quality of life that simply is not available through other forms of medical treatment.

Unfortunately, they can also be dangerous. Over the past several years, many implantable medical devices have proven to be defective, and these defective devices have caused countless serious and fatal injuries. There are a number of reasons why this is the case, and we will be exploring these reasons in a five-part series, starting with this article focused on the risks of so-called “510k clearance” (which is different than an “FDA approval” and is not really an approval of the government at all).  

FDA Approvals for Implantable Medical Devices: 510K Clearance vs. Premarket Approval

All medical devices sold in the United States are subject to approval or clearance for marketing by the U.S. Food and Drug Administration (FDA). The approval standards vary for different types of devices, and for “Class III” devices (those that support or sustain human life), a “process of scientific and regulatory review to evaluate the safety and effectiveness of [the device],” in most cases. As the FDA explains:

“PMA is the most stringent type of device marketing application required by FDA. The applicant must receive FDA approval of its PMA application prior to marketing the device. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s).”

Note that we said PMA (or Premarket Approval by the Food & Drug Administration) is required in most cases. This is because the FDA has adopted a rule that allows medical device manufacturers to skip this process entirely in some instances.

Under the FDA’s 510k process, premarket approval is not required for any new medical device that is “substantially equivalent” to a device that is already legally on the market. Instead, the device manufacturer must simply notify the FDA that it intends to market the substantially equivalent device. It is up to the manufacturers to decide what constitutes “substantial equivalence,” and this essentially creates an honor system that is deeply undermined by manufacturers’ financial incentive to sell new devices without the need to go through the lengthy and expensive PMA process. The safety threshold for the 510K clearance is so low that a medical device that is “substantially equivalent” to a device that has been recalled due to safety issues might very well be permitted to remain on the market. 

As a result, defects in medical devices brought to market through the 510k clearance process are common, and data suggest that more than half of these defects result from design and manufacturing issues. These are issues that would likely be caught during the far more rigorous Premarket Approval process. We have represented numerous clients in cases involving defective implantable medical devices with “510k clearances,” many of whom have suffered life-altering complications or lost loved ones as a result of implants that were never reviewed by the FDA.

Coming Up in Part Two…

In the next article of our five-part series on implantable medical device safety concerns, we will discuss issues related to the recall process and how Class I, Class II and Class III recalls come much too late for many patients.

Speak with a Florida Product Liability Attorney at Searcy Denney

With offices in West Palm Beach and Tallahassee, our firm represents clients throughout Florida and nationwide in defective medical device claims. If you have questions and would like to speak with an attorney, we encourage you to call 800-220-7006 or contact us online for a free consultation.

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