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Home » FDA town hall provides no additional clarity on non-review of LDTs for pandemic
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FDA town hall provides no additional clarity on non-review of LDTs for pandemic

Oct. 21, 2020
By Mark McCarty
The U.S. FDA’s recent decision to pass on any emergency use authorization (EUA) filings for tests for the COVID-19 pandemic is well known, but the agency had a chance to lend some additional information on that question in the Oct. 21 town hall. Despite the opportunity to clarify some of the underlying questions, Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health (OIR), said little more than that the change was made “largely because the FDA cannot require an EUA, according to the HHS statement.”
Medical technology Regulatory Coronavirus FDA

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