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BioWorld - Friday, April 17, 2026
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Home » FDA’s Stenzel: Agency willing to be ‘very flexible’ for at-home COVID-19 test
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FDA’s Stenzel: Agency willing to be ‘very flexible’ for at-home COVID-19 test

Sep. 17, 2020
By Mark McCarty
The diagnostic industry in the U.S. and elsewhere has scrambled to keep up with the COVID-19 pandemic, and one of the key developments will be a test that can be used at home without medical supervision. However, Tim Stenzel, director of the U.S. FDA’s Office of In Vitro Diagnostics and Radiological Health, said on the Sept. 16 diagnostic town hall that the agency is keen on authorizing such a test, but has yet to receive any emergency use authorization filings. “We want to see a home test submission, and we’re willing to be very flexible here,” Stenzel said.
Medical technology Regulatory Diagnostics Coronavirus U.S. FDA

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