Statement from FDA Commissioner Scott Gottlieb, M.D., on how modern predicates can promote innovation and advance safety and effectiveness of medical devices that use 510(k) pathway
Earlier this week, the FDA announced new steps to modernize FDA’s 510(k) clearance pathway, used for low- to moderate-risk devices that are substantially equivalent to a device already on the market, known as a predicate device. These changes include a new pathway for these devices that we laid out in a draft guidance and discussed in our Medical Device Safety Action Plan that we issued in April.
The 510(k) pathway is used for the majority of devices that the FDA reviews. Manufacturers often rely on comparative testing to predicate devices to demonstrate that a new device is substantially equivalent to the predicate. A key part of our announcement is our intent to use our authorities to push for the use of more modern predicate devices. Today, I want to explain why predicate modernization is a key component of promoting innovation to help patients access safe and effective treatments.
When new devices rely on older predicates, they may not be accounting for, in their new submissions to the FDA, the latest advances in technology that could benefit patients. Older predicates might not reflect the newest performance standards or the FDA’s most recent understanding of the benefits and risks associated with a type of device. We want to create policy vehicles that will move the market toward reliance on newer predicates that reflect more modern characteristics related to their safety and performance. Among the immediate steps we’re seeking are to make public information about cleared devices that demonstrated substantial equivalence to older predicate devices, focusing on those that use predicates that are more than 10 years old. We’ll seek public feedback on whether predicates older than 10 years are the right starting point and if there are other actions we should take to advance the use of modern predicates.
We know that from 2015 through 2018, approximately 20 percent of 510(k)s that were cleared based on substantial equivalence to a predicate device relied on a predicate that was more than 10 years old. We don’t think these devices are unsafe—they met our standards for reasonable assurance of safety and effectiveness—but we are concerned that this practice of relying on predicates that are old, and may not reflect modern performance characteristics, means that some devices are not continually improving. Yet beneficial iteration is at the heart of health technology advancements that can truly benefit patients.
As devices become increasingly complex, it’s important that they meet the latest standards for cybersecurity, interoperability, biocompatibility and usability engineering. The FDA has recently advanced policies on these issues, and we know that older predicates often don’t meet our more recent expectations.
For example, older bedside monitoring systems that are interconnected to nursing stations may not incorporate the latest protections against cybersecurity threats. Older devices that rely on wireless communication may not incorporate the latest protections against interference from other technologies. And older devices that incorporate radiofrequency or laser technology may not meet the newer consensus standards adopted by the FDA. In these cases, manufacturers of new devices may use these older devices as predicates to obtain FDA clearance, but given ongoing improvements in technology, we must evaluate whether it’s best for patients when manufacturers rely on predicates for demonstrating substantial equivalence that don’t reflect features that have improved the safety and performance of modern products.
As we consider the use of older predicates, we will also identify device types where there are clear benefits to relying on more modern technology to demonstrate substantial equivalence and obtain FDA clearance of a 510(k). For example, hemodialysis systems have modernized through miniaturization to improve usability. X-ray systems have modernized using controls to limit patient exposure to radiation. Infusion pumps have modernized to better detect and measure the formation of drops of the medication they are intended to deliver. These are examples of device types where pushing for the use of more modern predicates, and sunsetting older predicates as appropriate, could improve patient care and outcomes.
Our efforts at 510(k) modernization—and our efforts to promote reliance on more up-to-date predicates—will also include a closer examination of devices with documented safety issues that were cleared based on older predicates. We want to push product developers to embrace newer predicates with improvements in technology so that patients and providers will continually have access to safer and more effective devices.
At the same time that we pursue efforts to sunset older predicates, we are advancing new policies to make it more efficient to develop new predicates that reflect modern principles for safety and performance.
In the coming months, you’ll hear more from us about the use of older predicates, as we seek to provide additional transparency around this practice. We believe that encouraging product developers to use more recent predicates will advance health technology and lead to more competition in the marketplace.
We’ll be taking additional steps to enhance the FDA’s review of medical devices and ensure we maintain our global gold standards for safety and effectiveness.