Since the university’s August announcement, the federal government has changed its guidelines for laboratory-developed tests like the one created by the U. of I., no longer requiring FDA emergency use authorization if the lab is appropriately federally regulated, according to the U.S. Department of Health and Human Services.
In August, Pritzker said FDA had given emergency use authorization to the U. of I.’s saliva-based COVID-19 test. FDA now says it never issued any such OK.
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