On Thursday, there was a bit of a whisper going around that HHS Secretary Leavitt had killed the IVDMIA guidance. I'm not sure where this rumor came from, but couldn't help noticing that Thursday was also the last day of a major healthcare conference in the Bay Area.
In any event, I thought I should comment.
At this point, it's safe to say that IVDMIA will not be enacted under the Bush Administration. It's difficult to predict whether IVDMIA will move higher or lower on the priority under the Obama Administration. There are so many other priorities it could complete with... on the other hand, it's an easy win.
There's no way to know for sure how this will play out, but I'll stick my neck out to predict one thing: the rumors of IVDMIA's death are greatly exaggerated. FDA has given no indication that they are losing interest in complex LDTs and headlines like the Quest Vitamin D snafu aren't helping create a mood for reduced oversight.
IVDMIA may not be happening as soon as we thought it might. It may not even end up being the specific guidance document we're expecting. But you can take this to the bank: One way or another, stricter, IVDMIA-type rules will come to pass in the lifespan of the product you're developing now. If you're making any important decisions based on rumors, I'd urge you to reconsider.
