Replies to post #216253 on Biotech Values

[biomaven0]

>>The above sounds like a non-ITT comparison, but this is a press release from the FDA itself!

But it's from the device side rather than the drug side. My impression is they tend to be much more casual.

This is of interest though:

The Dermapace System was reviewed through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices of a new type for which there is no legally marketed predicate device to which the device can claim substantial equivalence. This action also creates a new regulatory classification that would allow future devices to go through the FDA's 510(k) process, whereby devices can demonstrate substantial equivalence to this predicate device.