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Home » FDA eyes self-administered testing for COVID-19 antigen tests
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FDA eyes self-administered testing for COVID-19 antigen tests

Sep. 2, 2020
By Mark McCarty
The need for self-administered surveillance testing finally has a few candidates, thanks to labs and test developers across the globe, and the U.S. FDA is keen on exploiting the opening. Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said on the agency’s Sept. 2 testing town hall that the agency is interested in a test intended to be self-administered multiple times compared to a test validated under a single test approach, a flexibility that may prove critical in advancing the U.S. approach to testing for the COVID-19 pandemic.
BioWorld MedTech Regulatory Coronavirus Diagnostics U.S. FDA

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