I’ve gotten a couple calls about the recent XDx AlloMap IVD MIA 510(k) clearance. Many of my clients are wondering how a product can be cleared under guidelines that are still draft. What is going on over at OIVD?
Labs have always had the opportunity to get FDA clearance or approval on their assays. This has happened long before IVD MIA was first published. In addition, the FDA, in the draft guideline, maintains that they have always had the authority to regulate these types of assays, but have shown enforcement discretion so far.
It’s not outside of the FDA's authority to require applications for these assays and is certainly not a problem if they want to accept and clear applications for them before the guideline is finalized.
At the moment FDA is giving assay developers a choice as to whether or not CLIA labs want to bring their multivariate assays to FDA for review. And for those that believe that gaining FDA clearance or approval is the right approach, they now have a clear path to do so. However, this optional approach won’t last forever. Even if IVD MIA doesn’t get finalized, it appears there is agreement that multianalyte tests and in particular complex genetic tests may need additional regulation (SACGHS Report).
There’s going to be a lot more discussion about IVD MIAs coming up. One forum to get some answers at is the upcoming AMDM meeting. I’ll be talking along with other IVD experts including Elizabeth Mansfield from the FDA.