The rumor mill has been buzzing today about the imminent release of the finalized IVDMIA guidance.
When politics are involved, you don't want to count any un-hatched chickens. Especially not this chicken. Even so, my sources are telling me this is happening in December. I'm sure I'll have more to say when we see the final guidance. For now, let the wailing and gnashing of teeth commence.
But wait, there's more. In what is perhaps the regulatory equivalent of a Black Friday doorbuster, we may be getting two new guidances in December instead of just one.
There is also apparently a new guidance on the way that covers marketing activities around RUO products. It's hard to say much about this until I see it (or even know for sure that it's real) but it's fair to say that this could be a significant document. It'll also be draft, I assume, so that will give us all something new to talk about in 2010.
We don't have a lot of extra capacity, but we do have a little. If you don't already have a plan for IVDMIA, this might be a good time to give us a call.
Tags: Advertising & Promotion, FDA, IVD, IVDMIA
