CDRH New - September 24, 2021

U.S. Food and Drug Administration sent this bulletin at 09/24/2021 09:11 AM EDT

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U.S. Food and Drug Administration - CDRH New

September 24, 2021

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on September 23, 2021. To view listings for other dates, see CDRH New - News and Updates.

New Emergency Use Authorization
- Life Sciences Testing Center COVID-19 Test
Updated Emergency Use Authorizations
Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200080 added)
Class I Recall: Armstrong Medical Limited Recalls AMSORB PLUS PREFILLED G-CAN 1.0L Due to Reduced Gas Flow to Patients During Anesthesia
Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - October 6, 2021
Federal Register: Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability

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