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Home » FDA’s Stenzel: EUA conversion draft in the works, but agency still swamped with EUAs
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FDA’s Stenzel: EUA conversion draft in the works, but agency still swamped with EUAs

Nov. 18, 2020
By Mark McCarty
Many of the developers of in vitro diagnostic tests will seek to convert their emergency use authorizations (EUAs) to conventional premarket filings, and Tim Stenzel, director of the U.S. FDA’s Office of In Vitro Diagnostics and Radiological Health (OIR), said a draft guidance for this conversion is in process. However, Stenzel said he could not predict when that draft might emerge, given that the agency is still scrambling to keep up with both EUA and conventional applications.
BioWorld MedTech Regulatory Coronavirus Diagnostics U.S. FDA

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