11/15付までの米国FDAによるCOVID-19絡みガイダ
関係者および興味のある方は、下記URLsの更新通知等をご参照
l 11/15付 News Release「Coronavirus (COVID-19) Update: FDA Updates Test Policies to Help to Ensure Accuracy and Reliability of Tests and Increase Access to At-Home Tests」
https://www.fda.gov/news-
［上記関連ニュース記事］
l 11/15付RAPS「FDA revises COVID test approach after HHS reverses Trump-era LDT directive」
https://www.fda.gov/news-
l 11/15付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-
l 11/15付Revised「Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised)」
https://www.fda.gov/media/
l 11/15付Revised「Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)」
https://www.fda.gov/media/
l 11/15付Updated「Coronavirus (COVID-19) and Medical Devices」
https://www.fda.gov/medical-
l 11/15付Updated「FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-
l 11/15付Reissued「Reissued the EUA for Molecular Diagnostic Tests for SARS-CoV-2 Developed And Performed By Laboratories Certified Under CLIA To Perform High Complexity Tests」
https://www.fda.gov/medical-
l 11/15付New「Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing」
https://www.fda.gov/medical-
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