What is the 510(k)?
Balancing Benefits, Safety, and Patient Needs

What does a tongue depressor have in common with an artificial knee and a heart monitor?  This is not trick question or an unsolvable riddle—all three are medical devices that must go through the U.S. Food and Drug Administration (FDA) for approval.  Many of us are exposed to medical devices on a regular basis but few of us give much thought to who develops these products, and even fewer take the time to consider how their benefits and safety were measured.   The process by which these products are evaluated and allowed for public use is essential to the quality of life of millions of people in the U.S., however most Americans know very little about it.

Thirty four years ago a framework to classify different types of medical devices was established.  The goal was to make it easier for simple products like tongue depressors, bandages, and gauze to be brought to market quickly, while at the same time setting more stringent requirements for complex, riskier devices.  The FDA is currently conducting an internal audit of the process by which most medical devices are approved—the 510(k) process.  Most would agree that periodic investigation of a three decades old process is a positive and necessary exercise, but it may affect you so it’s important to know the facts.

Changing the Norm

Simply put, many companies planning to introduce a medical device to the U.S. market must submit an application to the FDA called a 510(k).  Devices like medical imaging equipment and orthopedic implants are subject to the 510(k) process.  This process examines whether a new device is equivalent to an existing device.  To be cleared for sale, a new device must be as safe as an existing device and provide similar levels of benefits.  In certain cases, the FDA must also determine whether or not additional tests are needed before the device can be sold. 

The 510(k) process is more widely used now than ever before.  By one estimate, approximately 90% of medical devices in the U.S. have been evaluated through the 510(k) process.  Technological advances are driving this growth and the FDA leadership involved recognizes the importance of determining whether or not the process still provides the safest and most effective devices for consumers. 

Woodrow Wilson once said “if you want to make enemies, try to change something.” Because the FDA has not yet disclosed the scope of its audit, or the extent to which it intends to modify the 510(k) process, the media has fueled speculation that changes to the process could be significant and would result in costly delays for companies trying to bring new devices to market.  This has also led to fear among patient advocates that delays and new barriers to approval could force companies to reevaluate their future investments in new devices for patients who need them.  Further adding to the uncertainty and tension is an external review of the same process by the Institute of Medicine that was requested in conjunction with the internal FDA review. 

So how can the FDA adapt requirements to meet the complexities of twenty-first century technologies, appease critics who feel that the current 510(k) requirements are not strict enough, and avoid creating additional burdens on device makers that unintentionally stifle new product development?  The good news is they may be moving in the right direction.  Public reports have shown that the FDA’s goal is not to require huge increases in the amount of data required to prove safety and effectiveness of every new device, but rather to provide more clarity on what applications would require more data.  Collaborations between FDA experts and the scientific community are also being considered to help companies solve problems before products are even submitted for approval.  Only time will tell if these types of solutions will satisfy everyone.   

Ensuring Patient Access

The FDA is due to release a report on the 510(k) process this summer.  At a recent town hall meeting on the topic, the head of the FDA’s Center for Devices & Radiological Health said that the FDA would seek public comments on the report before making any changes.  While it has not yet decided what changes will be implemented, the agency has signaled a commitment to fostering innovation.

Many patient organizations are currently considering the pros and cons that a revamp of the 510(k) process will have on patient access to new medical devices.  When the FDA’s report is released, many of these organizations will likely weigh in on the proposed changes. By supporting groups like the Alliance for Aging Research and sharing your stories of how medical products have enhanced your life, you can help ensure that the voice of patients is heard on this issue.