FDA Commissioner Scott Gottlieb recently emphasized that “the most impactful way that we can promote innovation and improved safety in the 510(k) program is to drive innovators toward reliance on more modern predicate devices or objective performance criteria when they seek to bring new devices to patients.”
Common sense indicates that when conducting comparative testing on new devices, the benefits and risks of more modern technology should be considered. Conversely, older predicates (devices already on the market) might not closely imitate the new technology in modern devices. This is the current standard. Now, there is an efficient way to demonstrate that a new device is substantially equivalent to predicate devices.
“One of our goals is to ensure that the 510(k) program is keeping pace with the important innovations we’re seeing in device development,” according to Gottlieb. “We believe this means that, where appropriate, new medical devices coming to market under the 510(k) pathway should either account for advances in technology that can improve the safety or performance of these products, or demonstrate that they meet more modern safety and performance criteria.”
The FDA’s announcement reflects innovations on more modern predicate devices. Under the current framework, manufacturers can avoid a rigorous scientific standard to prove safety and efficacy by simply showing the new device is substantially equivalent to a predicate device, and that may grandfather back to another predicate device, until you get to a device that decades ago was proven to be safe and effective. But these older predicate devices may not reflect the modern technology so it really cannot be assumed that the 51ok devices are safe and effective. From 2015 to 2018, approximately 20 percent of 510(k)s were cleared based on substantial equivalence to a predicate device and relied on a predicate that was over 10 years old.
Even though technology is rapidly improving, consumers and patients can now have high confidence in their devices.
“Doing so would create more transparency about these technologies, with the goal of driving device manufacturers to offer patients devices with the latest improvements,” added Gottlieb. “However, we recognize that for some types of well-established technologies there is not a need for improvements, and reliance on older predicates would not only be appropriate but necessary.”
After the announcement, FDA Commissioner Scott Gottlieb, M.D., stated, “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.”