chevyman, on that page to the medical devices site...from the link.
on your computer do a (ctrl "f") with your keyboard keys hold down the contorl key and then the f key... this means "control find" and brings up a small window to type in a keyword(s) search on a webpage...
to this and then type in the word "label." you'll find a little more insight on "labeling" and "use."
as far as finding an equivalent... i presume yes...in the bigger picture...
thus, i again think the labeling thing is dotting i's crossing t's.
however, as simple as this dotting i's and crossing t's can be, i think it is wise that dean is going to reply to the FDA thoughtfully (i.e., not just send in a working prefab templated indication statement), and consider the FDA progress pertaining to the DViS and take a week and a half or so as his time-point goal to reply to them...
ask yourself this, did you ever have an idea and then try to put it down on paper and then have the pencil/pen in your hand and not be able to write... i've submitted manuscript for peer-reviewed medical journals... to write an abstract of the article is sometimes sorta tough depending on the article content. the abstract tells the readers what the article is... but the editor for the publication want the author(s) to also submit a cover letter telling them what it is... but wait isn't this what the abstract is... which is already a necessary piece of the manuscript pie... it can sorta hard to again paraphrase what you've already paraphrased... and the authors are speaking as the experts who have an intimate insight of the topic... i'm drifting but hopefully you get my point...
dean's gotta take in all the recent inquires by the FDA on the DViS and act accordingly to what the DViS is...in his reply.
for example, i've looked at this post 3 times in preview and made some corrections before submitting it.
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