FDA to modernize 510(k) medical device approval process

Posted on November 27, 2018


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 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.



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.


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.

You can read the full announcement here.