New data from the US Food and Drug Administration shows the growth of its breakthrough devices program, but may raise questions as to how effective the program is in getting innovative devices to market.
The breakthrough devices program, which launched as the expedited access pathway in 2015, grants regulatory advantages to some innovative devices that treat serious conditions. Products accepted to the pathway may benefit from “sprint discussions” with the FDA about the device development process and prioritized review of future regulatory submissions, among other perks