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BioWorld - Wednesday, May 21, 2025
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Home » Stenzel says FDA sees pressing need for automated reporting of at-home tests
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Stenzel says FDA sees pressing need for automated reporting of at-home tests

Sep. 12, 2023
By Mark McCarty

The U.S. FDA is keen on developing policies to guide testing regimes for future pandemics based on the experience with COVID-19, and the FDA’s Tim Stenzel said on a Sept. 8 advisory hearing that automated reporting of at-home tests would clarify questions such as the spread of the pathogen and how well the tests are performing. Stenzel, who is the director of the Office of In Vitro Diagnostics and Radiological Health at the FDA, said the U.S. government agencies have made a number of grants for development of automated reporting mechanisms for at-home tests, signaling an interest on the FDA’s part that automated reporting capabilities will be a priority when the next pandemic strikes.

BioWorld MedTech Diagnostics U.S. FDA

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