3 ms·

What happened in-regards to the device in the article? What class is it?

• Thriptic 9y ago
  It was one of 19 devices that were class 3 (high risk) but granted 510(k) exemptions due to precedent. Ultimately all of these devices were intended to be transitioned to the higher standard pma approval process normally associated with class 3 devices, but were allowed to leverage moderate risk 510(k) pathways typically granted to class 2 devices until pma processes were developed for them. FDA was slow in orchestrating the change, and so this was allowed to continue until these safety concerns manifested, forcing FDA's hand. I was actually not aware that this had happened as by the time I entered this space almost all of the class 3 devices in question had transitioned to pma. To my knowledge there are very few devices left where this is still the case.