Good Morning everybody,
I need to request some mechanical test results to make a side-by-side comparison between a predicate device and my subject device which I'm seeking clearance through a 510(k).
The doubt is if this kind of information could be released under a FOI request or not? If not, how would I know if the predicate mechanical properties are equivalent my subject device?
I need to request some mechanical test results to make a side-by-side comparison between a predicate device and my subject device which I'm seeking clearance through a 510(k).
The doubt is if this kind of information could be released under a FOI request or not? If not, how would I know if the predicate mechanical properties are equivalent my subject device?