Many products in the United States receive market approval through the FDA’s 510(k) process. A 510(k) submission demonstrates to the FDA that a device is as safe and effective as a legally marketed device. This process applies to any company that wants to market in the United States, a Class I, Class II, or Class III for human use that does not require a premarket approval application. Those undergoing the 510(k) process must compare the product to a device already on the market that is “substantially equivalent,” according to the FDA. While this FDA process intends to put more devices on the market in a way that minimizes costs and maximizes benefits, experts have criticized the 510(k) clearance. Critics of the process claim that it introduces too many unreasonably dangerous devices into the market without proper trials and research.
Difference Between 510(k) and Premarket Approval
The FDA requires individuals planning to market or distribute a device in the United States to obtain premarket approval or complete a 510(k) submission. The approval process depends on the device’s classification, which coincides with its potential risks. Premarket approval is the more rigorous process of the two as it subjects the device to strict clinical trials and laboratory studies. This is a more in-depth examination with higher standards that determines if a device is safe by putting it in clinical trials with human participants.
Compared to Premarket approval, the 510(k) is far less stringent since it waives the requirement of clinical trials and laboratory testing. To pass the 510(k), or premarket notification, individuals must submit evidence that compares and contrasts the device with a legally marketed device. The FDA approves the device based on the applicant’s claim that the device is substantially equivalent, not through new testing. If the submitter demonstrates that the device has similar intended use and technological characteristics, it can pass premarket notification. Or, if the device is technologically different from the compared device, the individual must show the device is at least as safe and effective as the already marketed device.
Shortcomings of 510(k) Process
Critics argue that the 510(k) process is too lenient and opens the door for hazardous devices that otherwise may not pass the FDA’s more meticulous premarket approval process. In 2017, the FDA approved nearly 82% of devices through the 510(k) premarket notification process. A study published in The Journal of the American Medical Association in 2021 concluded that devices with 510(k) clearance were 11.5 times more likely to be recalled than those that underwent premarket approval. Additionally, devices with 510(k) clearance also accounted for 71% of high-risk recalls.
Dr. Diana Zuckerman, the president of the National Center for Health Research, has spent years testifying before Congress regarding the drawbacks and failings of the FDA’s 510(k) clearance. Dr. Zuckerman advocated for better medical device safety regulations and argued, “Too many patients have been injured or killed by medical devices cleared through this very flawed short-cut known as the 510(k) process.” She maintains that the 510(k) process risks patients’ lives since numerous of these life-sustaining devices have never been tested on humans before.
Overhaul of 510(k) Clearance
In 2012, several members of Congress attempted to pass the Sound Devices Act, which aimed to remedy a loophole in the 510(k) process. The bill would have prevented a device from reaching the market if the applicant claimed it to be substantially equivalent to a recalled device. However, Congress did not enact the bill. Therefore, a device can still receive 510(k) approval based on its similarity to a previously recalled device.
Over the years, many recalls have involved devices that received 510(k) clearance. Courts and medical experts agree that the 510(k) clearance does not effectively guarantee a product’s safety. Several lawsuits have been filed against devices that made it to the market through a 510(k) submission. Yet, the FDA has not remedied the premarket notification process to address these relaxed standards and issues.