7/13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。
l7/13付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19
l7/13付Updated「Coronavirus (COVID-19) Update: Daily Roundup July 13, 2020」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-july-13-2020
l7/13付Federal Register「Authorization of Emergency Use of Certain Medical Devices during COVID-19」
https://www.federalregister.gov/documents/2020/07/14/2020-15137/authorization-of-emergency-use-of-certain-medical-devices-during-covid-19
l7/13付Federal Register「Revocation of Authorization: Emergency Use of an In Vitro Diagnostic Device for Detection of Antibodies Against SARS-CoV-2, the Virus that Causes Coronavirus Disease 2019 (COVID-19)」
https://www.federalregister.gov/documents/2020/07/14/2020-15138/revocation-of-authorization-emergency-use-of-an-in-vitro-diagnostic-device-for-detection-of
l7/13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
l7/13付Updated「FAQs on Diagnostic Testing for SARS-CoV-2」
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-testing-sars-cov-2
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。
l7/13付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-
l7/13付Updated「Coronavirus (COVID-19) Update: Daily Roundup July 13, 2020」
https://www.fda.gov/news-
l7/13付Federal Register「Authorization of Emergency Use of Certain Medical Devices during COVID-19」
https://www.federalregister.
l7/13付Federal Register「Revocation of Authorization: Emergency Use of an In Vitro Diagnostic Device for Detection of Antibodies Against SARS-CoV-2, the Virus that Causes Coronavirus Disease 2019 (COVID-19)」
https://www.federalregister.
l7/13付Updated「In Vitro Diagnostics EUAs」
https://www.fda.gov/medical-
l7/13付Updated「FAQs on Diagnostic Testing for SARS-CoV-2」
https://www.fda.gov/medical-
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