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BioWorld - Thursday, December 18, 2025
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Home » U.S. FDA encouraging COVID-19 test developers to file 510(k)s
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U.S. FDA encouraging COVID-19 test developers to file 510(k)s

May 27, 2020
By Mark McCarty
The number of tests of various types for the SARS-CoV-2 virus are still growing, but the emergency use authorization (EUA) program is not the only option for developers. Timothy Stenzel, director of the Office of In Vitro Diagnostics and Radiology, said on the agency’s May 27 town hall that the agency would like to see test developers file for a 510(k) for their tests when the data are sufficient to support an application, adding that any such clearances will not affect the U.S. FDA’s interest in keeping plenty of similar tests on the market via the EUA mechanism.
BioWorld MedTech Regulatory Coronavirus Diagnostics 510(k) FDA

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