5/6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。
この数週間の緊急通知発出を見る限り、米国の医療状況が相当苦しんでいることが窺われます。
本邦が同様の状況に陥らないことを期待しましょう。
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。
l5/6付Updated「Coronavirus (COVID-19) Update: Daily Roundup May 6, 2020」
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-may-6-2020
l5/6付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19
l5/6付ガイダンス「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」～医療機器の不足を防止または軽減するためのガイダンスです。
https://www.fda.gov/media/137712/download
l5/6付Webinar通知「Webinar - 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 - May 11, 2020」
https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-notifying-cdrh-permanent-discontinuance-or-interruption-manufacturing-device-under-section
［上記関連ニュース記事］
l5/6付RAPS「CDRH explains notification requirements for device shortages under CARES Act」
https://www.raps.org/news-and-articles/news-articles/2020/5/cdrh-explains-notification-requirements-for-device
l5/6付Updated「FAQs on Diagnostic Testing for SARS-CoV-2」
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2
l5/4付通知「Medical Gloves for COVID-19: Manufacturing, Purchasing, Importing and Donating Gloves During the Public Health Emergency」
https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/medical-gloves-covid-19-manufacturing-purchasing-importing-and-donating-gloves-during-public-health
この数週間の緊急通知発出を見る限り、
本邦が同様の状況に陥らないことを期待しましょう。
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
l5/6付Updated「Coronavirus (COVID-19) Update: Daily Roundup May 6, 2020」
https://www.fda.gov/news-
l5/6付Updated「Coronavirus Disease 2019 (COVID-19)」
https://www.fda.gov/emergency-
l5/6付ガイダンス「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」～
https://www.fda.gov/media/
l5/6付Webinar通知「Webinar - 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 - May 11, 2020」
https://www.fda.gov/medical-
［上記関連ニュース記事］
l5/6付RAPS「CDRH explains notification requirements for device shortages under CARES Act」
https://www.raps.org/news-and-
l5/6付Updated「FAQs on Diagnostic Testing for SARS-CoV-2」
https://www.fda.gov/medical-
l5/4付通知「Medical Gloves for COVID-19: Manufacturing, Purchasing, Importing and Donating Gloves During the Public Health Emergency」
https://www.fda.gov/medical-
執筆者について
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
コメント
/
/
/
コメント