As far as I'm able to see it, the Pathway Genomics business plan comes from the Underpants Gnomes, to wit:
- Make large, FDA-flaunting announcement
- ???
- 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
