The FDA 510 (K) Approval Process

The 510 (k) Clearance or approval process is one of two ways that a medical device manufacturer can obtain Food and Drug Administration approval, although legally, a device authorization in this section is not a true "approval." 510 (k) Authorization simply gives the company permission to market its product, as opposed to a "predicate" device.

The 510k approval process has sparked some controversy in recent years as it has led to the availability of several harmful devices, including metal-on-metal hip implants 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 in one of 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 received FDA approval and has been on the market (this is known as the" predicate device"). If the manufacturer can successfully demonstrate such equivalence, the safety testing requirements will be waived.

Devices that are eligible for 510 (k) clearance are those that fall within the FDA's Class III category. These are devices that are permanently implanted in the body of a patient through surgery and include pacemakers, joint prostheses, and IVC Filters used to prevent embolisms, among other products.

To get 510 (k) Clearance, the manufacturer has yet to compare the safety and efficacy of its product to a similar model that is currently legally marketed. The type of comparison required varies depending on the device and the degree of risk to the patients who will use it.

Such a comparison can examine the new device for its physical characteristics and how well it performs compared to the predicate device, using standard methods.

In other cases, the application is based on "lab tests" of the new device, during which its performance is compared with the known characteristics of the predicate device. Some devices are required to comply with regulations set by the FDA's Center for Devices and Radiological

Read More :- 510k submission