※追記更新（2020.08.20）
8/18付の米国FDAによるCOVID-19絡みガイダンス等の発出について、筆者のお好みでお伝えします。
関係者および興味のある方は、下記URLsのNews Release等をご参照ください。
l8/18付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19
l8/18付Updated「Coronavirus (COVID-19) Update: Daily Roundup August 18, 2020」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-august-18-2020
l8/18付Updated「In Vitro Diagnostics EUAs」
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas#individual-molecular
l8/18付「Considerations for Selecting Respirators for Your Health Care Facility」
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/considerations-selecting-respirators-your-health-care-facility
l8/18付「Manufacturing and Distributing Respirators for Health Care Use in the United States Under an Existing Emergency Use Authorization (EUA) During the COVID-19 Pandemic」
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/manufacturing-and-distributing-respirators-health-care-use-united-states-under-existing-emergency
l8/18付Updated「FAQs on Emergency Use Authorizations (EUAs) for Medical Devices During the COVID-19 Pandemic」
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/faqs-emergency-use-authorizations-euas-medical-devices-during-covid-19-pandemic
l8/18付Updated「FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/faqs-testing-sars-cov-2
l8/18付Updated「FAQs on Viral Transport Media During COVID-19」
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/faqs-viral-transport-media-during-covid-19
8/18付の米国FDAによるCOVID-19絡みガイダンス等
関係者および興味のある方は、下記URLsのNews Release等をご参照ください。
l8/18付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-
l8/18付Updated「Coronavirus (COVID-19) Update: Daily Roundup August 18, 2020」
https://www.fda.gov/news-
l8/18付Updated「In Vitro Diagnostics EUAs」
https://www.fda.gov/medical-
l8/18付「Considerations for Selecting Respirators for Your Health Care Facility」
https://www.fda.gov/medical-
l8/18付「Manufacturing and Distributing Respirators for Health Care Use in the United States Under an Existing Emergency Use Authorization (EUA) During the COVID-19 Pandemic」
https://www.fda.gov/medical-
［8/20付追記更新：上記関連ニュース記事］
●8/19付RAPS「FDA updates respirator EUA workflow」
https://www.raps.org/news-and-
l8/18付Updated「FAQs on Emergency Use Authorizations (EUAs) for Medical Devices During the COVID-19 Pandemic」
https://www.fda.gov/medical-
l8/18付Updated「FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-
l8/18付Updated「FAQs on Viral Transport Media During COVID-19」
https://www.fda.gov/medical-
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