FAQs on Diagnostic Testing for SARS-CoV-2 | FDA - 0 views
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Dennis OConnor on 02 Apr 20Explanation from DeAunne Denmark, MD, PhD : And just to clarify for all, since all of the testing jargon and landscape can be *extremely* confusing, especially now: The FDA has currently relaxed regulations for COVID diagnostics under "Emergency Use" (EUA). This authorizes, not approves, test kits, machines and devices to run those kits, and all other aspects involved in diagnostic testing. Authorize vs approve are very different animals under FDA. And you will see this repeatedly emphasized on the FDA site. But most often neglected, skipped over, mistaken in the wider press. Many articles and press releases use "approve" which is technically wrong - they mean authorize, or "grant use", or "use will not be objected to by FDA." If you have the stamina, I highly recommended reading as much of this as you can: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2 "Validation" is yet an additional aspect that is probably the grayest zone of all, since it is left to each company/testing entity how exactly this is done. Validation can range from excellent to pretty cruddy science and still meet FDA "standards". These will be the devilish details we need to sort out re: collaborating with partners. And will unfortunately likely be a big mess for many outpatient Drs trying to figure out which test to order.