FDA to Phase Out 510(k) Pathway in Favor of New Safety and Performance Based Framework

FDADirectorScott GottliebPh.D., Director of the Center for Devices and Radiological Health (CDRH)Jeff ShurenA Statement on Reform Was Recently ReleasedFDA 510 (k)Regulations, letFDAThe approval pathway can keep pace with the rapid development of complex technologies.

A 510(k) submission is a premarket application filed with the U.S. Food and Drug Administration (FDA) to demonstrate that the device seeking market clearance is as safe and effective as a legally marketed device that is not subject to Premarket Approval (PMA), i.e., it is substantially equivalent. In simple terms, the applicant must compare the device seeking clearance with one or more similar devices already on the U.S. market and provide evidence to support the conclusion of substantial equivalence.

FDAAnnounced that it will2019a comprehensive replacement launched in [Year]510（k) new approval pathway. For legacy devices (predicate device) will consider setting up10-year time limit.FDAaspect stated that this move is a practice ofFDAThis year4Medical Device Safety Plan Released in May. 

“The new technologies we are witnessing bring immense new hope to patients, but progress also introduces significant complexity, making the assessment of safety and efficacy more challenging,” the statement said. “The proposed improvements aim to effectively advance technologies that benefit patients while reinforcing the FDA’s gold standard to ensure safety.”

The 510(k) pathway has been in effect since 1976, but it has faced increasing scrutiny in recent years. The fact that the 510(k) framework, established in 1976, is undergoing reform at this juncture is largely attributable to Jeff Shuren, who spearheaded these changes. One year after he assumed the role of Director of the Center for Devices and Radiological Health (CDRH) in 2011, the CDRH conducted an assessment and ultimately recommended that the FDA completely abandon the 510(k) pathway.

Previously, the FDA dismissed these recommendations; however, as it refines policies to encourage innovation, news continues to emerge regarding efforts to enhance the safety of medical devices and phase out legacy baseline equipment.

Just one day before the FDA announced its reforms, the findings of an investigative journalism project led by the International Consortium of Investigative Journalists (ICIJ) were released. The investigation involved 252 journalists from 59 media outlets across 36 countries, including the BBC, The Guardian, and BMJ. The investigation revealed that implantable medical devices were inadequately tested, or in some cases not tested at all, before being used on patients, causing serious harm. The report also noted that, according to data from the U.S. Food and Drug Administration, more than 1.7 million people in the United States were injured and nearly 83,000 deaths over a ten-year period may have been related to medical devices. In addition, Netflix released a documentary in April this year titled Bleeding Edge, which exposes the realities of the medical device industry and has attracted significant attention.

Most people believe that high-risk medical devices implanted in their bodies are brought to market only after rigorous testing has proven them safe and effective. However, this is not the case. The U.S. Congress intends for all new devices to undergo premarket approval (PMA). Similar to the process for new drugs, PMA requires clinical trials in humans, compilation of all data, and submission to FDA scientists for review.

However, for the medical device industry, annual product improvements are common, and conducting human clinical trials for every change would be prohibitively expensive. Consequently, Congress established the 510(k) pathway. Under the 510(k) process, manufacturers need only demonstrate that their device is substantially equivalent to one or more legally marketed predicate devices.

David Kessler, who served as FDA Commissioner from 1990 to 1997, criticized this by stating: “The 510(k) pathway was originally intended for exceptional cases and is essentially a loophole, but the exception has become the norm. Unfortunately, most medical devices are now regulated under this framework.” Last year, the CDRH approved 3,173 products through the 510(k) process, accounting for 82% of all medical devices cleared by the FDA.

This has led to a vicious cycle, in which a medical device is approved based on its substantial equivalence to a previously approved device, which in turn was approved based on its substantial equivalence to an even earlier device.

In the documentary “Bleeding Edge,” Deborah Cohen, editor-in-chief of The BMJ, pointed out: “A cyclical chain has ultimately formed, and you will find that some previously approved devices have been recalled due to defects.”

The FDA does not evaluate predicate devices; even if a device has been recalled due to safety concerns, it can still serve as a predicate device, allowing another device to gain clearance through the substantial equivalence pathway.

However, the FDA has stated that data show nearly 20% of current 510(k) clearances are based on predicate devices that are more than 10 years old. This does not mean the products are unsafe; rather, it indicates that certain devices may not undergo continuous improvement, thereby hindering innovation in medical technology.

As evident from the FDA’s public statements, the Agency has been continuously refining the 510(k) submission process. Through this reform, the FDA aims to incorporate more modern and innovative medical devices and objective performance criteria into the 510(k) pathway. Specifically, the FDA will phase out legacy predicate devices, introduce objective standards, and comprehensively overhaul the 510(k) program.

First, the FDA stated in its announcement that a 10-year time limit would be imposed on predicate devices. This means that if a device manufacturer seeks marketing approval by demonstrating substantial equivalence to a predicate device, that predicate device must have been on the market for no more than 10 years.

The statement indicates that specific measures will continue to be advanced. In the coming months, CDRH is considering publicly posting on its website a list of devices marketed as substantially equivalent to predicate devices that have been on the market for more than 10 years.

The FDA also announced that it would finalize guidance in early 2019 to establish an alternative pathway to the 510(k) clearance process. The statement indicated that this alternative approval pathway would mean medical device manufacturers would rely on objective safety and effectiveness criteria to demonstrate substantial equivalence. The FDA stated that this approach updates the previous method of directly comparing new devices with predicate devices, thereby facilitating the adoption of modern standards to support emerging products.

The new approach will be renamed the Safety and Performance Based Pathway.

“Through this new approach, device manufacturers can directly demonstrate that a new device complies with modern device standards, which the FDA will establish or recognize as reflecting current technological principles. We hope that this effective new pathway will ultimately replace the practice of manufacturers technically comparing their new devices to specific, and sometimes older, medical devices.”