Nerdy Deep Dive on MSK IMPACT Approval Categories

This is a side bar to the main article, found here.
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De Novo Classification

The MSK IMPACT test was approved through a 510(k) De Novo pathway, which is familiar enough.  Classification letter here.

Regulatory Category 866.6080?

The letter classifies IMPACT as Regulatory Category 21 CFR 866.6080. 

Oddly enough, this category appears to be absent at eCFR, which I think of as the categorical reference for Code of Federal Regulations.   (Here, and look for 866.6080: the official CFR stops at 866.6060.)

However, the FDA's own website has a webpage for 866.6080, here.   It says the regulation was created on April 1, 2017.   This was a Saturday, a day when the Federal Register isn't published.  FDA just lists the name of the category, not further detail.

So 21 CFR 866.6080 appears to be a sort of phantom regulatory category --  found on the FDA's "CFR" page but not on the federal CFR page, despite having a claimed creation date of April 2017, plenty of time for the two sites to sync up.

Product Category PQM versus PQZ

Oncomine Target Dx is classed as Product Class PQP, "NGS Oncology Panel, somatic or germline variant detection system."   PQP is always a PMA submission.   See FDA webpage here.    Manufacturers using Class PQM include Illumina, Foundation, Thermo Fisher; see here.

Product Category PQZ has its own webpage also, here.   This is for  "Next generation sequencing based tumor profiling test."   It's classed as 510(k) based on 21 CFR 866.6080.  It is eligible for "Third Party Review," specifically, by the New York State Department of Health.

A PowerPoint that walks through all this with screen shots is here.