The FDA Medical Device Safety Approval Process is Flawed and May Get Worse

The U.S. Food and Drug Administration (FDA) is currently using a flawed regulatory framework to approve medical devices. The current framework has been unsuccessful in protecting people from dangerous drugs and defective medical devices, and it is unclear how an even faster track approval process is going to safeguard American consumers.

How does the FDA 510(k) approval process work now?

If a medical device manufacturer wants to get a medical device approved, and that device is similar to a device which already exists on the market, then the company can file a Premarket Notification, also called a 510(k) form. The 510(k) “is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to [Pre-Market Approval] PMA. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalence claims.”

To qualify as a “substantial equivalent,” the manufacturer must prove that the device:

• has the same intended use as the predicate; and
• has the same technological characteristics as the predicate; or
• has the same intended use as the predicate; and
• has different technological characteristics and does not raise different questions of safety and effectiveness; and
• the information submitted to FDA demonstrates that the device is at least as safe and effective as the legally marketed device.

If the FDA agreed with the equivalence, then it will grant the manufacturer clearance to market the device.

Upcoming changes to the 510(k) approval process

The issue that the FDA appears to have with the current process has to do with the equivalence requirement for the other devices, called predicate devices. As the Commissioner of the U.S. Food and Drug Administration, Dr. Scott Gottlieb, explains in a blog post, “FDA’s regulatory process has remained largely unchanged since it was first implemented 40 years ago. As a consequence, there are an increasing number of cases where this basic framework isn’t well-suited to reflect the innovation that we see today in certain technologies, and how we must evaluate those technologies.” He goes on to point out that “the predicate devices that new products must compare themselves to are sometimes 40 years old.”

Dr. Gottlieb’s argument is that proving equivalence between a product made with today’s technology, and one made with technology from 40 years ago, places undue burden on innovators and manufacturers.

To which we say, so what?

A less rigorous process is not the right answer

First of all, technology changes constantly; think of how often your cell phone needs to be updated, or how quickly a computer can become obsolete without upgrades. If a manufacturer creates a device that is dissimilar to anything created in the last 40 years, it is not equivalent – it is a brand-new device. And as such, it should be subject to a different set of rules.

More important, however, is this: There have been countless medical devices that passed through the 510(k) process and were implanted into the bodies of hundreds of thousands of patients, only to later discover that the medical product was defective. The following are just a few examples of defective medical devices that were 510(k) cleared, but still caused injury and illness in patients:

• Vaginal mesh
• Hernia mesh
• Metal-on-metal hip replacement
• Stents
• Pacemakers
• IVC blood clot filters

Obtaining FDA approval should not be easy. It should only be granted to products which have proven themselves safe, effective and necessary. While some adjustments could probably be made to a process that is 40 years old, saying that “certain issues could be ultimately resolved in the post-market setting, rather than the pre-market setting,” as Dr. Gottlieb does, strikes us as flippant. If a potentially life-threatening device can make it to market, it is the FDA’s job to stop it before it reaches the public – not deal with the fallout once it has already hurt an innocent person.

If you or a loved one has suffered an injury due to a defective medical device, the trial attorneys at McGowan, Hood, Felder & Phillips, LLC can help you obtain the justice and compensation you deserve. We handle complex cases and are committed to delivering results on your behalf. To set up a free consultation with a defective medical device attorney from our team, complete our contact form or simply call us today at 803-327-7800.