※追記更新（2020.04.08）
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のガイダンス等をご参照ください。
l4/6付Updated「Coronavirus (COVID-19) Update: Daily Roundup April 6, 2020」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-april-6-2020
l4/6付Updated「Medical Devices and the COVID-19 (Coronavirus) Pandemic」
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/medical-devices-and-covid-19-coronavirus-pandemic
l4/6付Updated「FAQs on 3D Printing of Medical Devices, Accessories, Components, and Parts During the COVID-19 Pandemic」
https://www.fda.gov/medical-devices/3d-printing-medical-devices/faqs-3d-printing-medical-devices-accessories-components-and-parts-during-covid-19-pandemic
l4/6付「Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency」
https://www.fda.gov/media/136733/download
l4/6付「Enforcement Policy for Extracorporeal Membrane Oxygenation and Cardiopulmonary Bypass Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency」
https://www.fda.gov/media/136734/download
l4/6付「Temporary Policy Regarding Enforcement of 21 CFR Part 118 (the Egg Safety Rule) During the COVID-19 Public Health Emergency」
https://www.fda.gov/media/136732/download
《注》食品関係です。
【4/8付追記更新】
4/7付のRAPSが「FDA Offers Expanded Use for ECMO, Cardiopulmonary Bypass and Ophthalmic Devices Amid COVID-19」と題して、上記通知の一部について関連記事を掲載しています。
興味のある方は、下記URLのニュース記事をご参照ください。
https://www.raps.org/news-and-articles/news-articles/2020/4/fda-offers-expanded-use-for-ecmo-cardiopulmonary-b
米国FDAによるCOVID-19絡みガイダンス等の発出につい
関係者および興味のある方は、下記URLsのガイダンス等をご参
l4/6付Updated「Coronavirus (COVID-19) Update: Daily Roundup April 6, 2020」
https://www.fda.gov/news-
l4/6付Updated「Medical Devices and the COVID-19 (Coronavirus) Pandemic」
https://www.fda.gov/medical-
l4/6付Updated「FAQs on 3D Printing of Medical Devices, Accessories, Components, and Parts During the COVID-19 Pandemic」
https://www.fda.gov/medical-
l4/6付「Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency」
https://www.fda.gov/media/
l4/6付「Enforcement Policy for Extracorporeal Membrane Oxygenation and Cardiopulmonary Bypass Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency」
https://www.fda.gov/media/
l4/6付「Temporary Policy Regarding Enforcement of 21 CFR Part 118 (the Egg Safety Rule) During the COVID-19 Public Health Emergency」
https://www.fda.gov/media/
《注》食品関係です。
【4/8付追記更新】
4/7付のRAPSが「FDA Offers Expanded Use for ECMO, Cardiopulmonary Bypass and Ophthalmic Devices Amid COVID-19」と題して、
興味のある方は、下記URLのニュース記事をご参照ください。
https://www.raps.org/news-and-
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経歴 ※このプロフィールは掲載記事執筆時点での内容となります
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