CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

CDRH New

September 29, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on September 28, 2020. To view listings for other dates, see CDRH New - News and Updates.

• New Emergency Use Authorizations
  • Genetrack SARS-CoV-2 Molecular Assay (Genetrack Biolabs, Inc.)
  • MosaiQ COVID-19 Antibody Magazine (Quotient Suisse SA)
• Updated Emergency Use Authorizations
  • Appendix A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China
  • Appendix B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories
  • OraRisk COVID-19 RT-PCR (Access Genetics, LLC)
  • AvellinoCoV2 test (Avellino Lab USA, Inc.)
  • PerkinElmer New Coronavirus Nucleic Acid Detection Kit (PerkinElmer, Inc.)
• Breast Implants - Certain Labeling Recommendations to Improve Patient Communication - Guidance for Industry and Food and Drug Administration Staff
• Saline, Silicone Gel, and Alternative Breast Implants - Guidance for Industry and FDA Staff
• Electronic Product Radiation Control (EPRC) Variance Application Process| FDA
• Federal Register: Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use
• Federal Register: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use
• Federal Register: Breast Implants; Certain Labeling Recommendations to Improve Patient Communication