How the FDA’s 510(k) Pathway Can Lead to Unsafe Medical Devices for Patients


Medical devices drive the progress and innovation of modern healthcare. Yet monitoring the safety and effectiveness of these devices is crucial for patient well-being. The US Food and Drug Administration (FDA) is responsible for medical device clearance and regulations. It has several pathways for approving these devices as well as measures to order FDA medical device recalls should they prove unsafe after going to market. One widely used pathway is the 510(k) pathway as it allows medical device manufacturers to bring their products to market faster. However, critics have scrutinized this pathway for allowing unsafe devices onto the field via loopholes and lax standards. Below, we will discuss the 510(k) pathway and how it can lead to unsafe medical devices for patients.

What is the 510(k) Pathway?

The 510(k) pathway is a premarket clearance process that allows a device to be cleared for market without the need for clinical trials if the FDA deems it “substantially equivalent” to a device already on the market. This means that if a new device is similar to a device already cleared for market, the new device in question can skip clinical trials in the approval process and doesn’t have to prove that it is safe or effective. The 510(k) pathway exists to expedite the market-clearance process for non-life-supporting or life-sustaining devices without unreasonable risk to the public.  Often advertisements for devices will claim to be FDA approved when they are only cleared. Most physicians and the public do not understand the significance of this difference.

Why The Pathway is Problematic

Critics have voiced concerns about the 510(k) pathway regarding its loophole allowing unsafe medical devices to be sold to patients. The main problem with the pathway is that it relies on the “substantially equivalent” standard, which is not always a reliable indicator of safety and effectiveness. The standard allows devices to go to market without the need for clinical trials. The reasoning is based on the argument that the medical devices in question are similar enough to those already on the market.

Another problem with the 510(k) pathway is that it does not require companies to disclose post-market safety data about the devices that they are using as comparators (i.e. the predicate device). Sometimes the predicate device is not even used in the same part of the body as the new cleared device. An example is the SiBone (iFuse) system which is used at the sacro-ileal region of the lower back and has been attributed to several deaths in the FDA’s adverse event database (called MAUDE). The predicate device was used in the foot.  

Additionally, the 510(k) pathway does not require companies to conduct pre-market safety studies to ensure that their devices are safe and effective. This means that if the agency clears a device through the 510(k) pathway and is later found to be unsafe, it can be difficult for the FDA to recall the device. 99% percent of device recalls are voluntary, not mandatory. 

Another worrying statistic concerning this pathway is it facilitates FDA clearance for over 95% of medical devices sold in the US. Yet manufacturers can leverage it to get clearance for their devices faster based on predicate devices. Many of these predicate devices are unsafe themselves.

Fortunately, the FDA has recognized there is potential for harm in the current 510(k) pathway. It is currently working towards strengthening the program with new guidance and criteria. Note, however, that this new pathway is optional for manufacturers.

Unsafe Devices Approved & Why An FDA Medical Device Recall May Not Be Sufficient

Fortunately, FDA medical device recalls can remove unsafe devices from the field. However, the best way to ensure patient safety is through prevention. Recalls, whether by manufacturer decision or issued by the FDA, are a lengthy process. By the time a manufacturer or the FDA issues medical device recalls, it may have already caused otherwise avoidable damage.

Several cases of unsafe medical devices approved through the 510(k) pathway support the criticisms against it. The DePuy ASR hip implant, for example, achieved FDA market clearance through the 510(k) pathway in 2005. The device was later found to be unsafe and was recalled in 2010. Another example is the power morcellator, a device used to remove uterine fibroids. The device made it through market clearance via the 510(k) pathway in 1991. Yet it went on to cause cancer in some patients. The damage continued until the FDA issued a warning about it in late 2013.

While there were no FDA medical device recalls issued for the device, the warning prompted medical device giant Johnson & Johnson to issue a voluntary worldwide recall, but they were the only manufacturer to voluntarily take swift action. Meaning while these devices caused harm under the radar, they continued to do so well after the FDA’s warning.

Don’t Wait On FDA Medical Device Recalls To Take Action

The FDA’s 510(k) pathway for medical device clearance has significant flaws that can lead to unsafe devices reaching the market. Manufacturers’ ability to clear devices through comparisons to similar, already-marketed devices has led to inadequate safety testing. Combine that with the lack of clinical trial requirements, and the frontline for patient safety becomes much less effective. The FDA’s limited resources and funding for post-market surveillance undermine its ability to quickly identify and address.Does your company, or any organization it depends on, rely on medical devices? If so, hoping that the FDA properly filters out all unsafe medical devices from the market is a risky decision. Instead, be proactive with Device Events. Our software decodes complex FDA medical device recalls and medical device reports to make your search more intuitive and faster than ever. Want to learn more about how we can help you keep your organization protected? Contact us today to take matters into your own hands.