FDA to modernize 510(k) medical device approval process
FDA Commissioner, Scott Gottlieb, M.D., announced Monday that the FDA is going to overhaul the 510(K) approval process for medical devices. The current process, approved in 1976, allowed medical device manufacturers to pursue an expedited approval for a device if they could prove the new product was substantially equivalent to those that were grandfathered in when Congress established the pathway.
Currently, 4 out of 5 devices are cleared through the 510(k) pathway.
The proposed change is to improve the process by requiring new devices to be compared to the benefits and risks of more modern technology, specifically, devices that are no more than 10 years old.
Gottlieb took to Twitter to explain the agency's reasoning for the change. He labeled the exchange a 'TWEETORIAL':
The 510(k) program has been strengthened and refined in many ways, especially in recent years, as the FDA’s Device Center has made a systematic, concerted effort to improve the program’s performance, predictability, efficiency and safety.— Scott Gottlieb, M.D. (@SGottliebFDA) November 26, 2018
The announcement from Gottlieb and the FDA comes on the heels of several news outlets publishing investigations into medical device injuries. The timing of this announcement very well could have been to show the media and public that safety is the agency's main priority in the modernization process of the 510(k) pathway.
We believe in merits of 510(k) process, but also believe it must be modernized to reflect advances in technology, safety, capabilities of newer devices. It’s time to fundamentally modernize an approach first adopted in 1976 c/w Medical Device Safety Action we issued in April 2018— Scott Gottlieb, M.D. (@SGottliebFDA) November 26, 2018
Gottlieb went on to explain that they are working to push innovation forward while ensuring that new and existing devices meet the FDA's gold standard for safety and effectiveness.
In 510(k), manufacturers often rely on comparative testing vs predicate devices to show a new device is as safe and effective as the predicate. But older predicates might not closely reflect the modern tech embedded in new devices or more current understanding of benefits & risks— Scott Gottlieb, M.D. (@SGottliebFDA) November 26, 2018
Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.— Scott Gottlieb, M.D. (@SGottliebFDA) November 26, 2018
Gottlieb share that in the next few months, CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. The agency is considering focusing on predicates that are >10 years old as a starting point, so the public is aware of those technologies.
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 while promoting greater competition to adopt modern features that improve safety and performance.— Scott Gottlieb, M.D. (@SGottliebFDA) November 26, 2018
You can read the full announcement here.