※追記更新（2020.12.03）
11/25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。
l11/25付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19
l11/25付News Release「Coronavirus (COVID-19) Update: FDA Issues New Policy on Dry Heat for Reuse of Certain Respirators」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-new-policy-dry-heat-reuse-certain-respirators
l11/25付最終ガイダンス「Enforcement Policy for Bioburden Reduction Systems Using Dry Heat to Support Single-User Reuse of Certain Filtering Facepiece Respirators During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency」
https://www.fda.gov/media/143985/download
l11/25付最終ガイダンス「Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency (Revised)」
https://www.fda.gov/media/137712/download
［12/3付追記更新：上記関連ニュース記事］
l12/2付RAPS「Device shortage guidance gets a COVID update from FDA」
https://www.raps.org/news-and-articles/news-articles/2020/12/device-shortage-guidance-gets-a-covid-update-from
l11/25付New「Bioburden Reduction Systems Frequently Asked Questions」～GMPとしても適用可能な内容です。
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/bioburden-reduction-systems-frequently-asked-questions
l11/25付Updated「Personal Protective Equipment EUAs」
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/personal-protective-equipment-euas#exhibit1
l11/25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
l11/25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
11/25付の米国FDAによるCOVID-19絡みガイダンス
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
l11/25付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-
l11/25付News Release「Coronavirus (COVID-19) Update: FDA Issues New Policy on Dry Heat for Reuse of Certain Respirators」
https://www.fda.gov/news-
l11/25付最終ガイダンス「Enforcement Policy for Bioburden Reduction Systems Using Dry Heat to Support Single-User Reuse of Certain Filtering Facepiece Respirators During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency」
https://www.fda.gov/media/
l11/25付最終ガイダンス「Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency (Revised)」
https://www.fda.gov/media/
［12/3付追記更新：上記関連ニュース記事］
l12/2付RAPS「Device shortage guidance gets a COVID update from FDA」
https://www.raps.org/news-and-
l11/25付New「Bioburden Reduction Systems Frequently Asked Questions」～GMPとしても適用可能な内容です。
https://www.fda.gov/medical-
l11/25付Updated「Personal Protective Equipment EUAs」
https://www.fda.gov/medical-
l11/25付Updated「Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2」
https://www.fda.gov/medical-
l11/25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-
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