CDRH New - March 18, 2021

If your email program has trouble displaying this email, view as a webpage. March 18, 2021 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on March 17, 2021. To view listings for other dates, see CDRH New - News and Updates. Revoked Emergency Use Authorizations BioFire Respiratory Panel 2.1 (RP2.1) Template for Test Developers of Serology Tests that Detect or Correlate to Neutralizing Antibodies (Word - 189 kb) Serology Template for Test Developers (Updated) (Word - 172kb) Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200031 added) Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - March 24, 2021 Class I Recall: ACIST Recalls Kodama Intravascular Ultrasound Catheter Due to Risk of Broken O-Ring Pieces Flushing into Arteries During Use Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated) Removal Lists of Tests that Should No Longer Be Used and/or Distributed for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated) FAQs on Viral Transport Media During COVID-19 (Updated)

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