FDA finalizes new 510(k) guidance, shifts away from aging predicate devices

The new guidance aims to modernize the process and generate more market competition.
By Laura Lovett
02:17 pm

Looking to modernize the 510(k) process, yesterday the FDA announced its final guidance establishing the framework for the new Safety and Performance Based Pathway. 

The biggest change to the 510(k) program is that instead of testing a new device in comparison to what is already on the market, new technology seeking clearance can be measured against a set of “objective, transparent and well validated safety and performance metrics.”

“The benefit of this approach is that the pathway will benchmark modern technology against modern standards while, at the same time, offering a potentially more efficient way to demonstrate that a new device is substantially equivalent to devices already on the market, and thereby ensure patients have timely access to beneficial products,” FDA Comissioner Dr. Scott Gottlieb and Dr. Jeff Shuren, director of the Center for Device and Radiological Health, wrote in a release announcing the news. “We also believe this new approach may drive greater market competition to develop safer devices. By using this pathway, manufacturers would have demonstrated that their products meet objective safety and performance criteria that are based on modern technological principles.”

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The officials also announced that the agency is seeking public comments on new ways to encourage innovation in the process. 

Gottlieb and Shuren note that the agency is considering whether or not to post a list of FDA-cleared devices which “demonstrate substantial equivalence to older predicate devices.” It said that on the plus side, this could create more transparency; however, it recognized that some older devices don’t need improvements and “reliance on older predicates would not only be appropriate but necessary.” 

Why it matters

According to the agency, 2017 saw 3,173 devices cleared through the 510(k) pathway, constituting 82 percent of all green lit devices that year. Of these, roughly 20 percent are based on predicate devices that are more than 10 years old and would fall under the scope of the finalized guidance.

What's the trend

This change has been on the table for a while. In November the agency released a statement announcing that it was eyeing potential updates to the 510(k) clerance pathway for medical devices, and in the time since has offered a steady drip of amendment proposals for the clearance process. 

“To be clear, we don’t believe devices that rely on old predicates are unsafe, or that older devices need to be removed from the market,” Gottlieb and Shuren wrote in the November statement. “However, we believe that encouraging product developers to use more modern predicates would give patients and their doctors a choice among older and newer versions of a type of device, promote greater competition to adopt modern features that improve safety and performance, and help make sure that newer devices reflect more modern technology and standards that can improve patient care and outcomes. It would help the overall product environment continue to evolve in the direction toward more modern performance standards.”


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