Tim G said...
Stephen S said...
I find this disclaimer the FDA forced Quest to make amazingly ironic given how badly the CDC/FDA screwed this up back in January/February.
This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA (Emergency Use Authorization) for use by authorized laboratories.
Thats like.... a feature! A selling point! Its something Quest and Labcorp should put on marketing material to sell more tests.
In general, the FDA does not approve or authorize the development and use of laboratory tests. CLIA '88 allows laboratories to develop and approve tests without approval from FDA or CMS. The FDA sounds a bit disingenuous ("We wash our hands of responsibility") The FDA is concerned with food and drug regulation (a good book to read about
the FDA is 'Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation' by Philip Hilts. The book responsible for the FDA's beginning was Upton Sinclair's "The Jungle", about
the meat processing industry in America( It reminds one of the descript
ion of the exotic animal market in Wuhan, China where coronavirus originated)******
Sinclair wrote the jungle to point out labor practices in the meat industry which exploited waves of immigrants, and he was also promoting socialism, ironically.
we had tests offered to use by the WHO which we refused and we were told coronavirus was under control and that 15 cases would soon go to near zero.
the horse is out of the barn but we do need the tests.