The FDA has no role in creating this test – or any other. They've just dangled a threat of prosecution over companies, hospitals, research labs, and universitie

The FDA has no role in creating this test – or any other. They've just dangled a threat of prosecution over companies, hospitals, research labs, and universities who wanted to develop & use a variety of tests – including tests that have proven very useful elsewhere. When they "authorize" something, all they've really done is removed the prior threat of fines & imprisonment. This threat exists even if the thing they're holding up had little to no risk of harm or confusing anyone. (People, especially those in research labs and the medical profession, are not idiots! Even all sorts of long-approved diagnostic tests have significant errors associated that doctors & patients need to discuss & account for! This administrative-law threat exists even if traditional product liability – as applies for all sorts of other product/service/info-product category – would be more than sufficient to ensure quality, & punish recklessness. The FDA's delays have held back US testing capacity for months. The current economic disaster, & many deaths, are a direct outgrowth of both the legislation which gives them this veto-power, and their incompetent exercise of the various discretionary powers they have. They could have offered the same arbitrary waiver that they finally did, on February 29, back in last December! Even now, urgently needed medical supplies are held up, waiting for FDA inspection/certification backlogs to clear: A news story: https://www.washingtonexaminer.com/opinion/fda-inspections-craziness-preventing-coronavirus-response https://www.washingtonexaminer.com/opinion/fda-inspections-c... Testimony from a Google employee & philanthropic investor: https://twitter.com/mekkaokereke/status/1241151194812186624 https://twitter.com/mekkaokereke/status/1241151194812186624 The FDA shouldn't get to tout themselves as doing a good thing with this "authorization" – when the risk of harm of such vitally-necessary new testing options is so small that a delay of days, much less months, is unwarranted. Let scientists, doctors, & patients experiment!