I previously mentioned the GenomeWeb blog post that suggested IVDMIA will be delayed at least 90 days because OMB wants to take IVDMIA through a Notice of Proposed Rule-Making (NPRM) process. Subsequently, a blogger at Gerson Lehrman has repeated this story as though it were established fact.
I can't rule out the possibility that the NPRM story is true, but it's certainly not an established fact. I've talked with some folks at FDA and so far they don't seem to know where this story comes from or who the sources might be. It may also bear mentioning that it's still not in the Federal Register. FDA has submitted two NPRMs this year (one as recently as yesterday) and IVDMIA isn't one of them. If this is the final hurdle IVDMIA needs to clear, why wouldn't it have moved forward by now?
The lack of evidence is not the only reason to be skeptical, however. NPRM is, as the name suggests, a process for announcing new rules. IVDMIA is not a new rule. It is a guidance that clarifies existing authority. If OMB has requested that FDA file an NPRM, I would guess that it has touched off an inter-agency turf war to clarify whether such a request is warranted.
As far as IVDMIA's timing goes, that could amount to the same thing, as a bureaucratic scuffle could easily take as long to resolve as an NPRM. Then again, it might not. All of which puts us back in the position we were in a couple weeks ago: having no idea when IVDMIA will finally come out.
Even so, it's worth knowing what you don't know.
[EDIT: clarified source of second link, changed ambiguous reference]
