FDA 510(k) Clearance Process

A spike in medical-device recalls in recent years has caused some to question the viability of the U.S. Food and Drug Administration’s medical-device clearance process, which one expert has labeled “the weakest and most nonsensical program in the FDA.”

In the second half of 2016 alone, more than 180 million medical devices were recalled.

Since 1976, all medical devices must be cleared by the FDA before they can be sold legally in the U.S., unless the agency has exempted the device from this requirement.

In regulating medical devices, the FDA follows rules that are designed to focus on cost and benefit. The office that oversees device regulation and approval, the FDA’s Center for Devices and Radiological Health (CDRH), receives 50 percent of its funding from fees paid by manufacturers.

CDRH oversees approximately 175,000 medical devices on the U.S. market, more than 18,000 medical device manufacturers and more than 25,000 medical-device facilities worldwide.

The two main avenues for the FDA to allow medical devices to be marketed in the U.S. are known as Premarket Approval (PMA), which requires clinical and laboratory studies and a detailed process to determine safety and effectiveness. On the other hand, 510(k) does not require any of that.

In fact, researchers have found that devices cleared through the 510(k) process are 11.5 times more likely to be recalled than devices that were subject to the more rigorous PMA process.

Also known as premarket notification, Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers to notify the FDA at least 90 days before marketing their new products unless the devices are exempt from 510 (k) requirements.

If a company can prove its device is “substantially equivalent” to another already on the market, it can forego clinical trials and testing, saving time and money. Unlike the more rigorous PMA standard, which is to reasonably ensure safety and effectiveness, the 510(k) standard is to determine whether a device is substantially equivalent to a legally marketed device.

In other words, when the FDA clears a device through 510(k), it is not examining if the product is safe or effective for use in patients. It is just agreeing with the maker’s claim that the device is similar to another device already on the market.

In making that determination, the FDA will conclude a device is substantially equivalent to a marketed device if:

It has the same intended use as the predicate device and the same technological characteristics.

Or it has the same intended use as the predicate device, has different technological characteristics, does not raise new questions of safety and effectiveness and the applicant can show that the device is at least as safe and effective as the marketed device.

The law allows the FDA to require study data from a 510(k) applicant, but the agency rarely takes that step.

A third pathway to market for manufacturers of some low- and moderate-risk devices is called De Novo. It is available for makers of these devices that are not similar to other devices on the market. This is described by the FDA as a risk- and evidence-based classification process.

De Novo may be an option for manufacturers with devices that the FDA says are not substantially equivalent to an existing device in response to the manufacturers’ 510(k) submission. It is also an option for device makers who determine on their own that there are no predicate devices.

De Novo requires information from the manufacturer about the potential benefits of the device, as well as the controls in place to ensure the safety and effectiveness of the device. In addition, the manufacturers are required to submit “any clinical or nonclinical data that are relevant to ensure reasonable assurance of the safety and effectiveness of the device.”

The FDA also grants Investigational Device Exemptions for certain devices to be studied via a clinical trial in order to collect safety and effectiveness data.

Because of its lower standards, the 510(k) program provides an avenue for companies to fast-track product development without having to go through expensive and time-consuming testing and clinical trials.

The FDA classifies devices into three categories, with Class III devices theoretically posing the highest risk. Most Class III devices must undergo a stringent PMA process, which requires clinical and laboratory studies, and extensive data, including information on manufacturing processes.

Technically, Class II devices are less risky and can be reviewed under 510(k). However, some risky devices are determined to be Class II because their manufacturers can demonstrate that they are “substantially equivalent” to another device that is already on the market.

Class I devices are generally exempt from the regulatory process and can be marketed without receiving clearance from the FDA. The only requirement is that manufacturers of Class I devices register their establishment and list their generic products with the FDA.

This classification process is somewhat muddled, and many devices that fall under the FDA’s definition of high risk are designated as Class II and are required only to obtain 510(k) clearance and not the more rigorous Premarket Approval.

For example, the definition of Class III includes devices that “sustain or support life, are implanted, or present unreasonable risk of illness or injury.” However, most devices that are implanted, such as hip and knee replacements, are considered by the FDA to be Class II, and subject to the 510(k) clearance process, and not required to have clinical tests before being allowed on the market and used in patients.

Between 95 and 98 percent of medical devices on sale in the U.S. were cleared by the FDA through the 510(k) process, meaning the vast majority of medical devices used on patients have received little government scrutiny.

One of the more controversial aspects of this process is that manufacturers can use it to get clearance for devices that are substantially similar to devices that were never determined to be safe and effective. Even more concerning, these so-called predicate devices — the ones legally on the market that are used for comparison to new devices — can be used to justify the sale of new devices even if the predicate devices have known design flaws.

Several members of Congress sponsored a bill in 2012 to close this loophole, but the proposal died in committee. That bill would have prevented the FDA from clearing a new device if it was based on an earlier product that was pulled from the market for causing serious harm to patients. Because this was not enacted, it is still legal for a new device to be cleared for sale on the basis of its similarity to a dangerous device.

The bill was written in response to reports of the serious injuries suffered from patients who received defective bladder mesh implants and metal-on-metal hip implants.

Consumers may believe that when medical devices are allowed to be used in patients, the FDA has given its official approval of the safety and effectiveness of the devices. In fact, federal law explicitly states that 510(k) clearance “does not in any way denote official approval of the device.” Any representation that creates the impression that the FDA has officially approved a product with 510(k) clearance is considered misleading and is illegal.

Zuckerman participated in a study published in 2014 in the Journal of the American Medical Association that focused on the fact that the FDA clears about 400 implanted medical devices that are considered moderate to high risk for market each year through the 510(k) process without requiring clinical testing. Although the law requires that the FDA make public the data used to determine that the devices are “substantially equivalent” to other devices, that was done in only 16 percent of the cleared devices examined by the researchers.

Zuckerman testified before Congress in 2008 in an effort to push for a requirement that implanted devices go through the PMA process before being allowed for sale. Then in 2009, the Government Accountability Office issued a report saying the FDA was clearing Class III devices through the 510(k) process.

At the request of the FDA, a committee from the Institute of Medicine issued a report in 2011 that found that the 510(k) process was flawed and should be replaced with a new system that “provides a reasonable assurance of safety and effectiveness throughout the device lifecycle.”

Zuckerman said the panel found that “all these so-called moderate risk devices are killing people and causing serious harm.” The recalls categorized as high risk were almost entirely related to devices that had received 510(k) clearance.

As Consumer Reports noted in 2012, “Often the only safety ‘testing’ that occurs (with medical devices) is in the bodies of unsuspecting patients.”

Efforts were made to institute some reform, but Zuckerman said the device industry pushed back hard, and nothing happened. Instead, she said, changes were made in the opposite direction — deregulation to make it easier to get approval.

The Institute of Medicine report, Zuckerman said, “was a failure.” In the end, it was ignored.

In 2018, FDA began looking into improving the 510(k) clearance pathway. However, it hasn’t removed it. In November 2022, the agency reported it had cleared 27 products through the 510(k) for which it had supporting documentation.

Jeffrey Shuren, director of the Center for Devices and Radiological Health, told Congress in March 2017 that the agency has made progress in shortening the amount of time it takes to grant 510(k) clearance.

In 2010, he said, the average time for a 510(k) decision was 150 days. By 2015, the average was 133 days, a decrease of 11 percent.

Shuren said the agency has sped up the review process “without compromising the agency’s high standards.”

Critics of the 510(k) program say patients pay the price for its failings when they are treated with faulty products that make it to market without full testing.

Examples are transvaginal meshes, which have caused countless injuries and whose failures are the subject of thousands of lawsuits nationwide. Most transvaginal mesh devices on the market bypassed FDA testing because they were modeled after Boston Scientific’s ProtoGen sling. Even though the company later recalled the device because of shoddy design and a growing number of injuries, many other manufacturers still use the ProtoGen sling as a predicate device and model theirs after it.

Device manufacturers are also facing repercussions from similar problems related to metal-on-metal hip implants and other medical devices.

Courts have repeatedly held that the 510(k) review process does not relate to safety or effectiveness of medical devices. And because such devices do not have the government’s stamp of approval in these areas, the courts have made it easier to file lawsuits against manufacturers of devices that are cleared through this process than against makers of devices that withstood the stricter scrutiny of the premarket approval process.