Pathway's New World of Hurt

Wednesday, September 28, 2011

As far as I'm able to see it, the Pathway Genomics business plan comes from the Underpants Gnomes, to wit:

  1. Make large, FDA-flaunting announcement
  2. ???
  3. Profit!

Pathway, you'll recall, was responsible for the Walgreens debacle that helped put DTCG vendors under the hot glare of the regulators. Now they're back for a repeat performance, claiming that FDA has classified their saliva collection tube as Class I, 510(k) exempt.

That might come as a surprise to other saliva collection vendors, who seem to believe that 510(k) clearance is required. That's our interpretation too.

It will be interesting to see what gets published first: the retraction or the warning letter. I expect to see one or the other pretty soon.


UPDATE (9/29/11) FDA weighs in: "Registration is not a classification process"


Tags: 510(k), Advertising & Promotion, FDA, Public Statements, Warning Letters

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