What is the FDA's 510(k) Device Approval Process?

When discussing the approval of certain medical devices, companies sometimes invoke a process called 510(k). But what is the Food and Drug Administration’s 510(k) approval process? First, there are three levels of medical devices classified by the FDA. Class III devices are those with the highest risk, usually those that keep a patient alive or something similar. Class II devices are an intermediate range, where the FDA allows a given amount of information to suffice for approval. Class I devices present minimal risk to consumers and are often items like arm slings that need minimal approval and oversight. The 510(k) approval process is used for Class II and Class III devices, of which it is estimated that the majority (if not close to all) are cleared through this expedited procedure.

Congress has been pushing the FDA to revamp its 510(k) process, and the agency recently said that it would consider 25 changes to the system.

As part of the premarket submission process, a device manufacturer must prove that a prospective device is “safe and effective.” One way companies can do this is by proving that their product is functionally identical to a previous product considered safe and effective. The 510(k) approval process requires manufacturers to demonstrate "substantial equivalence" (SE) to a legally marketed device. Premarket notification requires companies to report their intents to the FDA at least 90 days before marketing. Companies are required to do this for any new device or one that has been significantly altered.

There are significant and obvious problems with this process, though:

• First, this process is substantially cheaper and easier than premarket approval. Companies need not conduct clinical research, and thus there is no guarantee that the product is safe.
• Second, the new device is not required to be superior in quality or efficacy to the previous device, just functionally equivalent. Therefore, these products may be only as effective as products that were made 25 years ago.
• Third, if the predicate device is ever found to be defective or is pulled for safety reasons, the devices based on it (and approved due to it) are allowed to remain in the market. The Institute of Medicine said that about 29 percent of devices cleared through this system are no longer on the market but can be cited as the rationale for another product’s safety.
• Fourth, every device made does not have to refer back to the original pre-1976 predicate. Any device approved in the 510(k) approval process can then be used as a predicate for another device.

The FDA 510(k) approval process has gotten some press recently as it was invoked by Johnson & Johnson when their Ethicon unit released the Gynecare Prolift vaginal implant in March, 2005. The problem is, the product was not officially approved by the FDA until 2008, and it has reportedly caused serious problems in thousands of women around the world. J&J’s Prolift and Gynecare TVT meshes were based on Boston Scientific Corp. (BSX)’s ProteGen mesh, which was pulled after safety concerns. The FDA said that the 510(k) did not apply in this case, concluding that marketing and sale of the product began “without appropriate” clearance, but not clarifying their stance.

Congress has been pushing the FDA to revamp its 510(k) process, and the agency recently said that it would consider 25 changes to the system. Until then, though, the thousands of women that have experienced serious problems with J&J transvaginal mesh and other products cleared through the 510(k) process will likely not find much comfort in this type of system. It is clear that an overhaul is necessary injured by a medical device, you may be eligible to file a lawsuit against the manufacturer seeking compensation for any damages incurred. To receive a free consultation, fill out the no-obligation form on the right.