fda, page-4

Interesting issue harvett.

My understanding is that equivalency with urine is now off the agenda - that it is now recognised that the 510k route is not the appropriate path to take for FDA clearance. There are apparently other mechanisms (but I am not up to speed on this) which require more lab evidence and studies - but not in terms of establishing equivalency with a predicate device (ie urine device). The process continues with a different set of parameters - this time hopefully achievable, albeit taking more studies to get it there.

I'm looking forward to an investor update that clarifies these issues - plus the outcomes of meetings with FDA officials later this month. We should know a lot more after that.