Monday, December 18, 2017

Regulatory Nerd Corner: The Regulation for the MSK IMPACT test does not exist in the CFR


For regulatory nerds, the MSK IMPACT test, recently cleared by the FDA as a de novo Class II test, has a product code (PZM) and a regulatory classification, 21 CFR 866.6080.

The Class II decision memorandum is here (DEN170058).   The product code PZM webpage at FDA is here.

  • However, the US Code of Federal Regulations or CFR has no regulation under 21 CFR 866.6080.  Regulations stop at 866.6060.  Here.
  • Yet, the FDA has a webpage saying that 866.6080 was created on April 1, 2017.
    •  (Ha ha?  Not only was that April Fool's Day, but it was a Saturday, when the Fed Reg doesn't publish).  Here.  
  • In short, the regulation as numbered on the FDA CFR webpage at FDA fail to foot to any actual regulation in the real Code of Federal Regulations, which would be here.    
The solution to the puzzle is not entirely satisfying, but here it is.  In order to clear a product as a de novo 510(k) product, there has to be a classification order which means there has to be a 510(k) category to put the product "into" such as 21 CFR 866.nnnn.    (See the FDA guidance on de novo classification processes, October 2017, here.)     So yes, the FDA internally created 21 CFR 866.6080 (sic), but will (eventually) publish an article in the Federal Register creating that regulation, at which point the new category will appear in the national CFR that everyone can access.  In the guidance (UCM080197), FDA says (a) it will issue the order to the sponsor and classify the device in that letter, and (b) "we will then publish a final order in the Federal Register, etc.   So it gives the appearance that the "regulation" exists on the FDA website before it appears in the FR or CFR.  And in this case, the FDA regulatory creation is dated April 2017, the Sloan Kettering first example of a product is November 2017, and the Federal Register publication will be December 2017 or in 2018. 

I suppose a Sherlock Holmes FDA sleuth could have figured out that something big was up if they tracked the sudden mystery appearance of 866.6080 on the FDA website as a Class II gene panel test last spring, but he wouldn't have known it would contain oncology genes that are otherwise PMA level CDx biomarkers. web page for the regulation, 21 CFR 866.6080 ("Created April 1")

Actual 21 CFR 866.nnnn Section at Federal CFR (Dec 18 2017)

FDA has a page on procedures for Direct Final Rulemaking, but it is predicated on publication in the Federal Register, which I've been unable to find for 866.6080.  Here.

FDA Commissioner Gottlieb was sworn in May 11, 2017.