The 510(k) Clearance process is one of two ways by which a medical device manufacturer can obtain approval from the Food and Drug Administration, although legally, a device clearance under this section is not a true “approval.” 510(k) Clearance simply gives the company permission to market its product, based on comparison to a “predicate” device. The 510(k) Clearance process has stirred some controversy in recent years, as it has led to the availability of a number of harmful devices, including metal-on-metal hip implants, artificial knees and mesh repair products.
Specifically, this section of the Federal Food, Drug and Cosmetic Act “...allows [the] FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories” when a manufacturer wishes to “reintroduce a device that will be significantly changed or modified.” The applicant must demonstrate that the new device is “substantially equivalent” to one that has already been granted FDA approval and has been on the market (this is known as the “predicate device”). If the manufacturer can successfully demonstrate such equivalence, safety testing requirements are waived.
Devices that are eligible for 510(k) Clearance are those that fall into the FDA's Class III category. These are devices that are permanently implanted into a patient's body by means of surgery, and include pacemakers, joint prostheses, and IVC filters used to prevent embolisms, among other products.
In order to obtain 510(k) Clearance, the manufacturer must still compare its product's safety and efficacy with a similar model currently being legally marketed. The type of comparison required varies, depending on the device and the degree of risk to the patients who will be using it. Such a comparison may examine the new device for its physical characteristics and how well it performs compared to the predicate device, using standard methods.
One example of this would be surgical gloves, which are typically tested using standardized methods established by recognized organizations such as ASTM International and the International Organization for Standardization (ISO). These tests would measure the material of the glove for durability and compatibility with the human tissues and fluids with which it would come into contact.
In other cases, the application is based on “bench tests” of the new device, during which its performance is compared to the known characteristics of the predicate device. There are also devices that are required to conform to regulations established by the FDA's Center for Devices and Radiologic Health (CDRH), known as “Special Controls.” These regulations can govern anything from the labeling of a given product to the design of specific components.
In a number of instances, “equivalency” has been an inadequate measure of device safety and efficacy. One example was a prosthesis known as the Attune Knee System, manufactured by Johnson & Johnson's DePuy division. When DePuy applied for pre-market approval under Section 510(k), it claimed the Attune product was “substantially equivalent” to a similar knee replacement from Zimmer Biomet, the NextGen CR Knee System. However, the “equivalence” stopped short when it came to the surface of the tibial tray, which is attached to the top of the shinbone. Because the surface was smooth, the cement used for the adhesion had nothing to which it could stick, resulting in a high number of device failures.
The Attune Knee represents one of several devices that have “slipped through the cracks” and have turned out to be defective and dangerous, even though they were supposed to be “substantially equivalent” to a similar predicate device. Because of this issue, the 510(k) process has drawn criticism from consumer watchdog groups. Despite numerous failures, injuries and resultant lawsuits, this process continues to be available to medical device manufacturers.