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FDA To Let Unauthorized COVID-19 LDTs Stay On Market During Review

By Kelly Lienhard / January 12, 2022 at 4:07 PM
FDA will let unauthorized laboratory-developed COVID-19 tests remain on the market while they undergo review by the agency, as long as developers submit data by this Friday (Jan. 14), an FDA official told test developers Wednesday (Jan. 12). The agency plans to reach out directly to developers with any questions. “We wanted all the tests that had been developed to be able to stay on the market while we review,” Timothy Stenzel, director of FDA’s in vitro diagnostics and radiological...


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