米国FDA/COVID-19絡みのガイダンス等の発出と更新(2021年7月16日付)

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の更新通知等をご参照ください。

●  7/16付Updated「Coronavirus (COVID-19) | Drugs
https://www.fda.gov/drugs/emergency-preparedness-drugs/coronavirus-covid-19-drugs

●  7/16付News Release「Coronavirus (COVID-19) Update: July 16, 2021
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-july-16-2021

●  7/16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

●  7/15付Updated「Removal Lists of Tests That Should No Longer Be Used and/or Distributed for COVID-19: FAQs on Testing for SARS-CoV-2
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/removal-lists-tests-should-no-longer-be-used-andor-distributed-covid-19-faqs-testing-sars-cov-2

●  7/15付Updated「Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/notifications-and-emergency-use-authorizations-faqs-testing-sars-cov-2

●  7/15付New「Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices - New Product Codes
https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices

●  7/15付Updated「Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance Documents
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/adverse-event-reporting-medical-devices-under-emergency-use-authorization-eua-or-discussed-covid-19

●  7/15付Updated「Risk of False Results with the Curative SARS-Cov-2 Test for COVID-19: FDA Safety Communication
https://www.fda.gov/medical-devices/safety-communications/risk-false-results-curative-sars-cov-2-test-covid-19-fda-safety-communication

●  7/15付Updated「In Vitro Diagnostics EUAs - Molecular Diagnostic Tests for SARS-CoV-2
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2

●  7/15付Updated「In Vitro Diagnostics EUAs - Serology and Other Adaptive Immune Response Tests for SARS-CoV-2
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-serology-and-other-adaptive-immune-response-tests-sars-cov-2

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