CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

CDRH New

October 2, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on October 1, 2020. To view listings for other dates, see CDRH New - News and Updates.

• New Emergency Use Authorizations
  • Alimetrix SARS-CoV-2 RT-PCR Assay (Alimetrix, Inc.)
  • iC SARS-CoV2 Test (Tempus Labs, Inc.)
  • Access IL-6 (Beckman Coulter, Inc.)
• Updated Emergency Use Authorizations
  • Appendix A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China
  • Xpert Xpress SARS-CoV-2/Flu/RSV (Cepheid)
• MQSA National Statistics
• Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - October 7, 2020
• FAQs on Testing for SARS-CoV-2 (Updated)
• Presentation and Transcript added to Safety and Performance Based Pathway Criteria for Certain Device Types Final Guidances Webinar - September 24, 2020