It seems that the FDA is moving forward to update their overall medical device approval process.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626838.htm
Manufactures currently have essentially been able to expedite the approval process if they could prove that their new product was substantially equivalent to a predicate.
This new announcement is encouraging companies to base new products on devices that are no older than ten years.
It seems that 20% of products cleared through the 510(k) pathway are based on a predicate device that is more than ten years old.
It appears that the FDA has plans to finalize it’s guidance on establishing an alternative accelerated pathway in 2019.
