CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

CDRH New

October 8, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on October 7, 2020. To view listings for other dates, see CDRH New - News and Updates.

• New Emergency Use Authorizations
  • AQ-TOP COVID-19 Rapid Detection Kit PLUS (SEASUN BIOMATERIALS, Inc.)
  • UCLA SwabSeq COVID-19 Diagnostic Platform (University of California, Los Angeles (UCLA))
  • ZEUS ELISA SARS-CoV-2 IgG Test System (ZEUS Scientific, Inc.)
• Re-issued Emergency Use Authorization
  • Aptima SARS-CoV-2 assay (Hologic, Inc.)
• Updated Emergency Use Authorizations
  • MobileDetect Bio BCC19 (MD-Bio BCC19) Test Kit (Detectachem Inc.)
  • OmniPATH COVID-19 Total Antibody ELISA Test (Thermo Fisher Scientific)
  • Appendix A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China
• Recommendations on Providing Clear Instructions to Patients Who Self-Collect an Anterior Nares (Nasal) Sample in a Health Care Setting for SARS-CoV-2 Testing - Letter to Health Care Providers
• FAQs on Testing for SARS-CoV-2 (Updated)
• FAQs on Viral Transport Media During COVID-19 (Updated)
• Presentation and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - September 30, 2020
• Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - October 14, 2020
• Press Release: FDA Issues Warning Letter to Battelle Memorial Institute, a Manufacturer of an Authorized Decontamination System Used on Respirators
• Clinical Outcome Assessments (COAs) in Medical Device Decision Making (Updated)
• Patient Preference Information (PPI) in Medical Device Decision-Making (Updated)
• List of Patient Preference-Sensitive Priority Areas (Updated)