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Dangers of FDA 501(k) Classification

When new products or medical devices are considered for approval for the consumer market, manufacturers must first undergo a rigorous system to have the device approved. The U.S. Food and Drug Administration (FDA) divides approved medical devices into three categories: Class I, II, and III. Class I devices are not subject to as much regulatory control as Class III—Class III devices are usually those which carry a greater risk to the patient or consumer.

There are several steps that a device must go through to be approved for market. The first, for most devices, is Premarket Notification (known as 501(k) approval). According to the FDA, most Class I devices can sidestep 501(k) approval because of their low risk factor. Most Class II and Class III devices require 501(k) approval.

The 501(k) system, according to the FDA, requires manufacturers demonstrate that the device they are attempting to get approved is “substantially equivalent to one legally in commercial distribution,” according to another FDA article. A device manufacturer has 90 days before a device is released to market to submit a 501(k), and the FDA, by law, has 30 days to respond to the petition.

The danger of 501(k) classification is that a device, if it is proved to be “substantially equivalent”—and the degree of substantive equivalence is not an exact science— the device can bypass more protective steps that help to keep faulty or untested devices out of the consumer market.

Devices that are exempt from having to complete 501(k) are varied, and while definitely on the more benign end of the medical device spectrum, can still cause serious patient damage in the event of a malfunction. These include (but are not limited to): cardiovascular devices, dental devices, neurological devices, and general and plastic surgery devices.

If you or someone you know has experienced negative side effects or physical damage from a device that you suspect may have been approved through the 501(k) FDA approval process, sidestepping traditional testing routes, you may be eligible for compensation. Contact an Arlington Heights defective medical device attorney today.

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