Is the 510k Approval Process Outdated?

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Does new always equal better?

“New” and “improved” have been marketing buzzwords ever since the early days of Madison Avenue. A newer version of a car or airplane or charcoal grill usually is the culmination of years of use and lessons learned from failures. It’s logical to believe that the newest version of something represents the best that technology and human ambition have to offer. But do they always mean the same thing? And how does this relate to medical devices?

The 510k process requires a predicate device

More than eight out of every 10 medical devices that made it to market in 2018 were cleared through the 510k submission process. This is also required when an existing device has significant changes or modifications to design, components, methods of manufacture, or intended uses. The route to the market for these Class II medical devices includes comparisons to a previous device. This is called a predicate. The choice of a predicate device resolves a number of complexities in the approval process. An existing device is assumed to be safe and effective and serves as physical proof that the device is appropriate for medical use. By comparing a new device to this, it creates a standard that the FDA can use to determine the efficacy of the new device.

The issue is that some predicate devices are more than 10 years old. This is an indication that the devices aren’t undergoing significant improvements.

What happens when new doesn’t equal better?

Many Class II medical devices have been recalled or taken out of the market because they were not as good as their predicates. If a device that was cleared is found to not perform as well as the predicate device, it is possible for a manufacturer to use the newer device as a predicate for another device. This would be done to avoid comparisons to an older device that performs better leading to a deterioration of the standard. When new advances in technology are compared to older technology that has successfully been used as a predicate, the new technology may be prevented from reaching the patient.

The FDA is working to streamline the process

It is comforting to think that all medical devices get better with new advancements in technology and by knowledge gained through clinical trials and actual use. The FDA regulations are there to make sure the process evaluates new devices against advances in technology. This new 510k clearance pathway will allow a medical device manufacturer to compare the performance of some new devices to FDA-identified criteria rather than measuring them against predicates. This final guidance is planned to be released by the FDA in 2019. The hope is that these guidelines will be a more logical way to validate new devices, be a quicker pathway to acceptance and use, and eventually supplant predicate device comparisons.