10/7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。
l10/7付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19
l10/7付Updated「Coronavirus (COVID-19) Update: Daily Roundup October 7, 2020」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-october-7-2020
l10/7付News Release「FDA Issues Warning Letter to Battelle Memorial Institute, a Manufacturer of an Authorized Decontamination System Used on Respirators」～警告通知です。
https://www.fda.gov/news-events/press-announcements/fda-issues-warning-letter-battelle-memorial-institute-manufacturer-authorized-decontamination-system
［上記関連ニュース記事］
l10/7付RAPS「FDA warns Battelle over EUA conditions for N95 decontamination system」
https://www.raps.org/news-and-articles/news-articles/2020/10/fda-warns-battelle-over-eua-conditions-for-n95-dec
l10/7付「Recommendations on Providing Clear Instructions to Patients Who Self-Collect an Anterior Nares (Nasal) Sample in a Health Care Setting for SARS-CoV-2 Testing - Letter to Health Care Providers」
https://www.fda.gov/medical-devices/letters-health-care-providers/recommendations-providing-clear-instructions-patients-who-self-collect-anterior-nares-nasal-sample
l10/7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
l10/7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#offeringtests
l10/7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#VTM
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。
l10/7付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-
l10/7付Updated「Coronavirus (COVID-19) Update: Daily Roundup October 7, 2020」
https://www.fda.gov/news-
l10/7付News Release「FDA Issues Warning Letter to Battelle Memorial Institute, a Manufacturer of an Authorized Decontamination System Used on Respirators」～警告通知です。
https://www.fda.gov/news-
［上記関連ニュース記事］
l10/7付RAPS「FDA warns Battelle over EUA conditions for N95 decontamination system」
https://www.raps.org/news-and-
l10/7付「Recommendations on Providing Clear Instructions to Patients Who Self-Collect an Anterior Nares (Nasal) Sample in a Health Care Setting for SARS-CoV-2 Testing - Letter to Health Care Providers」
https://www.fda.gov/medical-
l10/7付Updated「In Vitro Diagnostics EUAs」
https://www.fda.gov/medical-
l10/7付Updated「FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-
l10/7付Updated「FAQs on Viral Transport Media During COVID-19」
https://www.fda.gov/medical-
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